Randomized controlled trial of emotion regulation therapy versus cognitive behavioral therapy to address distress in cancer caregivers

Introduction

Up to 6 million people in the U.S. serve as family caregivers—partners, parents, siblings, children, extended relatives, and friends—to patients with cancer, 1 hereafter referred to as “caregivers.” Cancer care increasingly relies on caregivers to shoulder demanding responsibilities 1 , 2 at substantial costs: approximately half report clinically significant depression and/or anxiety, 3–8 often at higher rates than patients. 3 , 4 , 9 Caregivers frequently experience fear of cancer recurrence, a loss of control while witnessing suffering, and difficulties balancing hope with anticipatory grief during cycles of treatment and toxicities. 10–14 Untreated distress increases over time, 8 , 9 undermining caregivers’ ability to fulfill their essential role on the healthcare team. 15–18

Cognitive Behavioral Therapy (CBT) has the strongest evidence broadly in patient populations across the lifespan, 19–27 including dementia caregivers. 19–21 , 28–35 Among cancer caregivers, a growing literature shows some benefits of CBT for anxiety, depression, and insomnia. Our 2017 meta-analysis 36 of 36 CBT trials showed small effects on psychological, physical, and interpersonal wellbeing (Hedge’s g s < 0.20), and a more recent meta-analysis of 17 studies reported moderate effects on depression and anxiety ( g s = 0.32-.36). 37 Two trials of CBT integrating acceptance and commitment therapy (ACT) components (eg, acceptance, mindfulness) have shown efficacy among cancer caregivers. 38–41 However, a recent scoping review of contemporary CBT-based approaches for cancer caregivers reported inconsistent outcomes across studies. 42 These mixed findings likely reflect heterogeneity in how CBT-based approaches have been defined, adapted, and delivered across caregiver populations.

Emotion Regulation Therapy (ERT) 43 is a CBT-consistent approach that adds attention-regulation (eg, flexible shifting and sustained attention) and metacognitive regulation (eg, observing thoughts with distance and reinterpreting meaning to shift emotional responses) 44 , 45 together with mindfulness practices and emotional exposure exercises to target internal distress. ERT has established efficacy for chronic anxiety and depression in the general population, 46–48 and given its targeting of processes that commonly drive caregiver distress, 49–51 we adapted ERT for cancer caregivers (Emotion-Regulation Therapy for Cancer Caregivers; ERT-C). We subsequently demonstrated ERT-C’s feasibility, acceptability, and promising effects on anxiety, depression, worry, emotion regulation, and perseverative negative thinking in an open trial among caregivers of patients with diverse cancers, 52–54 and in addition to promising outcomes for caregivers, our initial RCT of ERT-C compared to waitlist control demonstrated improved quality-of-life (QOL) in the patients cared for by enrolled caregivers. 54 Together, these trials suggested that ERT-C, a contemporary CBT-based approach targeting regulatory mechanisms implicated in caregiver distress, may offer particular benefit for distressed caregivers.

In our overburdened healthcare system and given caregivers’ limited time, efficient, high-yield approaches are needed. No trial has directly compared 2 active, manualized CBT-based psychotherapies for cancer caregivers. ERT-C and CBT-C differ in therapeutic strategies, skill-building targets, and session content, 55 with ERT-C focused on attentional and metacognitive regulation, and values-guided re-engagement, while CBT is focused on cognitive restructuring, behavioral strategies, psychoeducation, and relaxation. As compared to CBT-C, ERT-C emphasizes homework and between-session skills practice, including the completion of daily monitoring forms. However, the approaches share a common CBT framework and include structured skills training and a focus on caregiver-specific distress. Moreover, while most prior studies of CBT-based approaches for cancer caregivers focused on specific cancers (eg, brain tumors), interventions must be tested across diagnoses to maximize reach and resource efficiency. Additionally, the inconsistent findings to date may also reflect the inclusion of caregivers without baseline distress, whereas robust effects depend on delivering interventions to individuals experiencing caregiving-related distress. To advance the field, we compared the immediate and longer-term efficacy of ERT-C versus traditional CBT for Caregivers (CBT-C) in distressed caregivers across cancer types and stages. We hypothesized that ERT-C would produce greater reductions in anxiety, depression, worry, and rumination (primary outcomes), as well as caregiver quality of life (QOL), burden, and patient-reported quality of life (secondary outcomes).

Materials and methods

Design and procedures

This multicenter randomized controlled trial compared the efficacy of ERT-C and CBT-C in improving anxiety, depression, worry, and rumination (primary outcomes), and QOL and caregiver burden (secondary outcomes) among distressed caregivers of patients with varying sites and stages of cancer. A full study design description has been previously published. 55 Participants completed assessments via REDCap at baseline (T1), within 1 week of the last session (T2), and at 3 (T3) and 6 (T4) months post-treatment. Following consent, caregivers were randomized to ERT-C or CBT-C and met with an interventionist for 8, 1-hour telemedicine sessions, completed within 16 weeks. Caregivers received both printed and digital copies of the intervention manual. Participants also completed a small battery of assessments in advance of each ERT-C/CBT-C session. Patients cared for by participating caregivers were invited to complete measures of QOL, perceived stress, and healthcare utilization at T1 and T3. Caregiver participation was independent of patient participation. Both patients and caregivers received digital gift cards or eChecks as incentives (caregivers received $5 for T1, $10 for each session, $10 for T2, $15 for T3, and $20 for T4; patients received $25 for T3). The study was approved by the IRBs at Memorial Sloan Kettering (IRB #20-407) and Dana-Farber Harvard Cancer Center (IRB #21-074) and registered at ClinicalTrials.gov ( NCT04802720 ).

Participants and recruitment

Participants were recruited between March 2021 and April 2024 via digital fliers on Memorial Sloan Kettering Cancer Center’s (MSK) and Massachusetts General Hospital’s (MGH) caregiver support pages, clinic schedule screening, and physician referrals. 55 Eligible caregivers were adults (≥18) of MSK or MGH patients treated within the past year, English-fluent, living in New York, New Jersey, or Massachusetts with any site/stage of cancer who received any type of treatment in the past 12 months whose self-reported Distress Thermometer scores were ≥4, with distress related to caregiving. Exclusion criteria were a history of bipolar disorder, schizophrenia, or schizoaffective disorder, or concurrent psychotherapy that could not be paused. Patients of enrolled caregivers were also invited if aged ≥18, English-fluent, and without severe cognitive impairment; only 1 caregiver per patient was allowed to enroll. All participants provided informed consent.

Randomization

Participants were randomized 1:1 to ERT-C or CBT-C using the MSK Clinical Research Database’s randomization module, stratified by site (MSK or MGH) with randomly permuted block lengths.

Interventions

Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

ERT-C is a CBT-based psychotherapy targeting early drivers of distress in caregiving—especially threat- and loss-related appraisals and associated unhelpful coping. 56 It trains caregivers to: (1) detect cues and link them to common response patterns (eg, worry, rumination, self-criticism, reassurance seeking, avoidance/withdrawal, compulsive behaviors); (2) use attentional skills to broaden, shift, and sustain attention under stress; (3) apply reflective thinking to step back from and reframe distressing thoughts; and (4) re-engage in rewarding, valued activities—even amid loss or threat—by practicing these skills in everyday caregiving situations.

Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)

CBT-C is grounded in the cognitive model, which posits that emotional, behavioral, and physiological responses stem from appraisals of situations. 57 Therapy focuses on modifying cognitions and automatic behaviors to improve emotion regulation and coping. For this study, CBT-C was adapted from prior trials with caregivers to include only traditional CBT components, 38 , 39 with modules on cognitive restructuring, relaxation, and caregiving-specific information.

Interventionists and adherence to treatment

Interventionists were pre- and post-doctoral clinical psychology externs trained to deliver ERT-C or CBT-C. Training included a half-day workshop and ongoing weekly group supervision to ensure fidelity. Intervention sessions were audio- and video-recorded, and a random subset of 60 cases was independently rated (by MH for CBT-C, MO for ERT-C) for treatment integrity. Raters scored frequency and skillfulness of interventionist actions across all 8 sessions per case. For frequency, ratings ranged from 0 (Interventionist did not address component/engage action) to 2 (Interventionist addressed component/engaged in action in more detail). Skillfulness ratings ranged from 0 (Interventionist was not skillful or performed poorly) to 2 (Interventionist performed action very skillfully).

Measures

Data were collected between March 2021 and February 2025.

Primary outcomes

Anxiety and depression were measured with the Hospital Anxiety and Depression Scale (HADS), 58 a 14-item questionnaire producing anxiety (HADS-A) and depression (HADS-D) subscales (range: 0-21). The HADS was administered at primary time points and weekly during the course of ERT-C/CBT-C. Worry was measured using the Penn State Worry Questionnaire (PSWQ), a 16-item measure of future oriented trait worry, 59 and rumination with the Rumination Subscale of the Rumination-Reflection Questionnaire (RRQ), a 12-item measure of perseverative thinking about the past. 60

Secondary outcomes

Caregiver quality of life was measured with the 35-item Caregiver Quality of Life Index-Cancer (CQOL), 61 and caregiver burden with the 24-item Caregiver Reaction Assessment (CRA), which evaluates self-esteem, family support, finances, and health. 62

Patients completed the following measures at T1 and T3: the PROMIS Global Health Scale (PROMIS-GH) 63 ; EORTC QLQ-C30, a 30-item questionnaire, to assess various domains of quality of life in patients with cancer 64 ; the Perceived Stress Scale (PSS), a widely used valid and reliable 9-item measure of the degree to which situations are perceived as stressful 65 ; and a 5-item National Survey on Drug Use and Health (NSDUH) module assessing health service utilization over the past 12 months. 66

Statistical analysis

The sample was described and dropouts (participants lacking T3 or T4) were compared to full study participants using a series of t -tests and Chi-square tests. Immediate effects (T1 to T2) on HADS-A and HADS-D were tested with mixed-effects regression models including time, arm, and their interaction, with random person-level intercepts and adjustment for site. This model incorporated weekly HADS scores during treatment and the parameter of interest was the interaction term. For other immediate outcomes that were not collected weekly during treatment and for maintenance effects (T2 to T4), the change score (T2-T1 for immediate, T4-T2 for maintenance) was regressed on a group indicator with adjustment for site. In mixed-effects models, missing data do not bias results under the missing at random assumption. 67 However, for modeling of change scores, we employed multiple imputation (MI) via chained equations with a fully conditioned specification model to account for missing data. 68 We used 20 imputed datasets, with outcomes at all timepoints (T1, T2, T3, T4), clinical site, randomization arm, and any baseline characteristics associated with completion included as auxiliary variables. Fit of the MI was evaluated by convergence and relative efficiency of the variance for the parameter of interest. As an additional exploratory analysis, effect sizes (Cohen’s d ) with 95% confidence intervals were calculated using Becker’s method and model-adjusted means reported for the overall sample and by arm. 69 Model-estimated means and effects sizes were extracted directly from the MI results and pooled, using Rubin’s method. 70 Change scores for patient outcomes were also regressed on arm, with adjustment for site. For one outcome, number of ER visits, a log link for Poisson regression was used due to the measure being a count. While not planned a priori , to protect against false discovery due to multiple testing, we adjusted all P values for the main parameter across all regression models using the false discovery rate (FDR) method. Treatment completion (all sessions) was compared between arms with Chi-square tests, and reasons for drop-out were summarized. The study was powered with the expectation of enrolling 240 caregivers, 120 patients, and with no greater than 20% attrition. Analyses were conducted in SAS version 9.4. 71

Results

Sample characteristics and attrition

Our CONSORT diagram is presented in Figure 1 . Of 414 potential participants screened, 253 consented and were randomized, 126 to ERT-C and 127 to CBT-C. Among randomized participants, 244 completed the baseline (T1) assessment, with 124 (51%) assigned to ERT-C. After baseline, 180 caregivers completed the post-treatment assessment (T2), 158 completed the 3-month assessment (T3), and 154 completed the 6-month follow-up assessment (T4). Overall, 80 (32.8%) of the 244 participants with T1 data had no T3 or T4 data, resulting in a 67.2% completion rate. Socioeconomic variables and assignment to condition did not account for differences between completers and non-completers. However, there were differences in psychosocial measures between completers and non-completers. On average, completers as compared to non-completers evidenced a 1.2-point lower HADS anxiety score ( P = .02), a 10-point lower QOL score ( P < .001), as well as lower impact of caregiving on their schedule ( P = .04) and finances ( P = .003).

Sociodemographic characteristics are presented in Table 1 . Participants were, on average, 52.9 years old and predominantly female (72.1%), white (80.7%), partnered (82.4%), and highly educated (52.9% reported completing professional/graduate school). Half of participants (51.2%) worked full time, and the majority (75.8%) reported a high annual income (>$75 000). In terms of caregiving characteristics, on average, caregivers had been in the role for 18.7 months and devoted 7.5 hours/day to caregiving, and the majority (70.5%) were the spouse/partner of the patient. The majority (82.8%) cohabitated with patients. In terms of patient characteristics, the majority had advanced cancer (15.6% Stage III, 42.2% Stage IV), with the most common sites being breast (13.9%) and brain (9.8%) cancer.

Treatment adherence

In terms of adherence to the treatment manuals, average ratings reflected close interventionist adherence: ERT-C frequency = 1.41, skillfulness = 1.82; CBT-C frequency = 1.71, skillfulness = 1.73. Raters also assessed treatment contamination (ie, elements of ERT-C in CBT-C, and vice versa) and interventionist engagement and rapport skills using a 0-4 scale (0 = Not Present, 4 = Always Present). Average contamination for ERT-C and CBT-C were low at 0.01 and 0.02, respectively. Ratings of interventionist engagement and rapport were high: 4.87 for ERT-C and 4.76 for CBT-C.

Primary and secondary caregiver outcomes

As seen in Table 2 and depicted in Figure 2 , analyses including weekly data that estimated the parameter of interest, time × group interaction, were not statistically significant (anxiety: P = .482; depression: P = .330) from baseline through post-treatment (immediate). That is, any improvements in these outcomes did not differ significantly between ERT-C and CBT-C. However, both models did reveal significant main effects of time (anxiety: b = −0.30, P < .001; depression: b = −0.20, P < .001).

Models of change scores are summarized in Table 3 . Consistent with the primary analytic results, the intercepts in models of the change scores for anxiety and depression were significantly less than zero but neither parameter estimate for the hypothesized randomization arm effect was significant. Two other immediate change scores, worry and caregiver QOL, also had significant intercepts, indicating an overall improvement across arms. However, the main effect of randomization arm was not significant in any of these models. All models across all imputations converged successfully and relative efficiency statistics for the parameter of interest (randomization arm) were all greater than 0.96.

The exploratory analysis of effect sizes for change scores includes both overall (aggregating across arms) and by arm. Overall, the greatest improvement immediately was demonstrated in anxiety (M = −3.44, SE = 0.3), which resulted in a large effect size ( d = −0.86). The other primary outcomes of depression (M = −1.74, SE = 0.3; d = −0.47) and worry (M = −4.60, SE = 0.7; d = −0.46) demonstrated medium sized effects, and rumination (M = −1.89, SE = 0.6; d = −0.24) a small effect. Overall, mean CQOL scores were reduced by over nine points (M = −9.59, SE = 1.4; d = −0.55). Of the burden domain scores, the largest effect was seen in Caregiver’s Esteem (M = 0.11, SE < 0.1; d = 0.22) which demonstrated a small-medium effect. Standardized effect sizes and model-adjusted means, for both time periods and randomization arms, are given in Table 4 .

Patient outcomes

Among the 244 eligible patients of enrolled caregivers, 87 (36%) enrolled and completed T1. At baseline, patients exhibited scores near the midpoint for physical (M = 34.6, SD = 10.3), mental (M = 38.4, SD = 9.6), and global health scores (M = 46.8, SD = 17.7) as well as for perceived stress (M = 17.7, SD = 7.6; see Table 5 ). On average, patients had around one ER visit in the previous year (M = 1.2, SD = 1.4). About half ( n = 47, 54%) of enrolled patients completed the T3 assessment. Follow-up completion was not statistically associated with baseline patient demographics or study measures, but several baseline measures (ie, physical health P = .050, mental health P = .053, and global health P = .061) trended toward significance in the direction of completers having better baseline values. Overall, the sample significantly improved in perceived stress and number of ER visits, as seen via the model intercepts. As with caregiver measures, a complete case analysis found that none of the patient change scores differed significantly by randomization arm, thus providing no support for the hypotheses. When MI was used to handle missing data, changes in both physical ( b = 6.12, P = .013) and mental health ( b = 5.70, P = .011) were significantly higher in the ERT-C arm. These findings of a group effect did not, however, hold up after FDR adjustment for multiplicity (adjusted P = .163 for both).

Treatment completion

A significantly greater number of caregivers randomized to CBT-C versus ERT-C completed treatment (99 versus 86, P < .02). However, when excluding individuals who never initiated treatment (ie, attended no sessions), the difference in completion rates between arms was not statistically significant. Among caregivers who attended at least one session of ERT-C or CBT-C, retention rates were comparable across arms. Commonly reported reasons for withdrawal or non-initiation included time constraints ( N = 12 assigned to ERT-C, N = 8 assigned to CBT-C) and the therapy not being a good fit ( N = 6 assigned to ERT-C, N = 2 assigned to CBT-C).

Discussion

This multicenter RCT is among the largest trials comparing 2 active, manualized psychotherapies for distressed cancer caregivers. Both ERT-C and CBT-C produced clinically meaningful reductions in anxiety (Cohen’s d = 0.86), depression ( d = 0.47), and worry ( d = 0.46), along with improvements in caregiver quality of life from pre- to post-treatment. However, our a priori hypothesis that ERT-C would outperform CBT-C was not supported; the two conditions did not differ significantly on any primary or secondary outcome at any time point. The effect sizes reported here correspond favorably to findings from prior meta-analyses. 36 , 37 Although we anticipated that ERT-C’s attention and metacognitive skills training would yield greater improvement than a traditional CBT package, our results highlight a critical lesson: for distressed cancer caregivers, engagement in any evidence-based CBT-informed intervention targeting caregiver-specific distress may be beneficial.

While the predicted group differences were not detected, two patient outcomes improved across the full sample: perceived stress and ER utilization. This pattern aligns with a prior RCT comparing ERT-C to a waitlist control, in which patients of caregivers randomized to ERT-C reported gains in QOL despite no significant change in their psychological distress. 54 These findings reinforce the buffering effect of caregiver mental health on patient overall health and emotional functioning, and highlight the downstream effects of caregiver engagement in empirically supported approaches on patients and the healthcare system.

In terms of attrition, non-completers (32.8% of individuals providing baseline data) reported higher baseline anxiety, worse quality of life, and greater financial burden than completers, suggesting that the most distressed caregivers faced significant challenges to engagement. However, the between-arm difference in treatment completion was driven by caregivers who never initiated treatment; completion rates did not differ by condition among individuals who attended at least one session. While multiple imputation addressed missing data under MAR assumptions, the clinical profile of non-completers warrants caution about the completeness of that assumption. Importantly, the willingness of all eligible caregivers screened to enroll during COVID-19 lockdown, and the successful recruitment of more caregivers ( n = 253) than planned ( n = 200), underscores the urgency of delivering psychosocial care and the feasibility of targeted, time-limited telehealth support.

Despite unsupported hypotheses, the trial demonstrates the benefit of empirically supported therapeutic components embedded in these CBT-based packages to address distress across diagnoses and the caregiving trajectory. Indeed, the overall effects may have been driven, in part, by common factors, including therapeutic alliance, expectancy for improvement, manualization, structured skill training, the caregiver-specific focus, and weekly contact. 72 Convergence at the symptom level does not, however, preclude the possibility that the two treatments engage distinct change processes, and planned secondary analyses will examine differential mechanisms of action in treatment-engaged participants.

Although we found significant improvements overall, the absence of a no-treatment or waitlist control arm means that pre-post changes may partially reflect a natural recovery trajectory, and we cannot isolate the contribution of the interventions from passage of time or regression to the mean. Another limitation is the restricted sociodemographic profile of participants. Future trials should include a non-active or non-CBT comparator, recruit more ethno-racially and geographically diverse caregivers, and evaluate delivery models that address time constraints and fit of treatment. Studies are also needed to address scalability beyond NCI-designated comprehensive cancer centers and delivery by a wider group of healthcare professionals. Finally, future work should examine cultural and linguistic adaptations (eg, delivery in Spanish), and the use of asynchronous or digital therapeutic platforms. Overall, our findings underscore the benefits of caregiver engagement in CBT-based approaches to care for caregivers and patients and highlight the promise of both ERT-C and CBT-C to meet the psychosocial needs of distressed cancer caregivers.

Acknowledgments

We thank our study interventionists for their generosity of time and thoughtful care for our participants (Richard Koch, Lauren Leffell, Julia Kurtz, Ayden Palmer, Amy Clara, Luciana Oliveira Dos Santos, Leah Walsh, Meghan McDarby, Kylie Steinhilber, Ivy Gosnell, Hillary Litwin, Allyana Wiviott, Ronit Yazdan, Brooke Duarte, Greta Jankauskaite, Stephen Lo, Leigh Andrews, Bianca Campagna, Lacey Granemann, Courteney Rae Koo, Hannah-Rose Mitchell, Laura Polacek, Hannah Schmitt, Ethan Metzger, Rohini Bagrodia, Roland Hart, Chantal Muse, Monica Kansas, Naomi Greenfield, Phillip Spaeth, Serena Mainiero, Esther Stern, Michal Clayton, Abby Szkutak, Josh Lipson, Swathi Srinivasan, and Nadine Taghian). We also thank our Clinical Research Coordinators, Morgan Loschiavo, Shibani Datta, Kate Morgan, Alison Wheeler, and Laura Dunderdale. Finally, we are so very grateful for the caregivers and patients who agreed to participate in this study.

Author contributions

Allison J. Applebaum (Data curation [lead], Formal analysis [equal], Funding acquisition [lead], Investigation [lead], Methodology [lead], Project administration [lead], Resources [lead], Supervision [equal], Writing—original draft [lead], Writing—review & editing [lead]), Jamie M. Jacobs (Conceptualization [supporting], Funding acquisition [supporting], Investigation [supporting], Methodology [supporting], Project administration [equal], Resources [equal], Supervision [equal], Writing—original draft [equal], Writing—review & editing [equal]), David M. Fresco (Conceptualization [equal], Funding acquisition [equal], Supervision [equal], Writing—original draft [supporting], Writing—review & editing [equal]), Michael A. Hoyt (Conceptualization [equal], Data curation [supporting], Funding acquisition [equal], Investigation [supporting], Methodology [supporting], Resources [equal], Writing—original draft [equal], Writing—review & editing [equal]), Elizabeth Schofield (Data curation [lead], Formal analysis [lead], Funding acquisition [equal], Methodology [supporting], Writing—original draft [equal], Writing—review & editing [equal]), Morgan J. Loschiavo (Data curation [lead], Project administration [lead], Writing—original draft [supporting], Writing—review & editing [supporting]), Mia S. O’Toole (Data curation [supporting], Writing—original draft [supporting], Writing—review & editing [supporting]), Laura E. Dunderdale (Data curation [equal], Project administration [equal], Writing—original draft [supporting], Writing—review & editing [supporting]), and Dougals S. Mennin (Conceptualization [equal], Funding acquisition [lead], Investigation [equal], Methodology [equal], Supervision [equal], Writing—original draft [supporting], Writing—review & editing [supporting])

Funding

This study was funded by the National Cancer Institute (R01CA244185, MPI A.J.A./D.S.M.).

Conflicts of interest

A.J.A. reports relationships with PsyOnc Partners, LLC, and Genmab. J.M.J. reports a consultant relationship with OncoveryCare, Inc. and Reunion Neuroscience. She serves on the board of directors for WeGotThis.org.

Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Ethics approval statement

All study procedures were approved by the Memorial Sloan Kettering Cancer Center (protocol 20-407) and the Massachusetts General Hospital Dana Farber/Harvard Cancer Center (protocol 21-074) Institutional Review Boards.

Patient consent statement

All participants were provided and signed the Institutional Review Board approved consent form.

Open science disclosure statement

The study was pre-registered at ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04802720?intr=Emotion%20Regulation%20Therapy%20for%20Cancer%20Caregivers%20%5C(ERT-C%5C)&rank=2 . The analysis plan was not formally pre-registered. De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author. Analytic code used to conduct the analyses presented in this study are not available in a public archive. They may be available by emailing the corresponding author. Materials used to conduct the study are not publicly available.

References

1 AARP National Alliance for Caregiving . Caregiving in the United States . AARP National Alliance for Caregiving ; 2020 .

2 Houser A , Gibson MJ. Valuing the Invaluable: The Economic Value of Family Caregiving, 2008 update . AARP ; 2008 .

3 Braun M , Mikulincer M , Rydall A , Walsh A , Rodin G. Hidden morbidity in cancer: spouse caregivers . J Clin Oncol . 2007 ; 25 : 4829 - 4834 . 10.1200/JCO.2006.10.0909 17947732

4 Cliff AM , MacDonagh RP. Psychosocial morbidity in prostate cancer: II. A comparison of patients and partners . BJU Int . 2000 ; 86 : 834 - 839 . 10.1046/j.1464-410x.2000.00914.x 11069410

5 Askari A , Madgaonkar JS , Rowell RK. Current psycho-pathological issues among partners of cancer patients . J Psychosoc Res . 2012 ; 7 : 77 - 85 .

6 Covinsky KE , Goldman L , Cook EF , et al The impact of serious illness on patients’ families. SUPPORT investigators. Study to understand prognoses and preferences for outcomes and risks of treatment . JAMA . 1994 ; 272 : 1839 - 1844 . 10.1001/jama.272.23.1839 7990218

7 Hudson PL , Thomas K , Trauer T , Remedios C , Clarke D. Psychological and social profile of family caregivers on commencement of palliative care . J Pain Symptom Manage . 2011 ; 41 : 522 - 534 . 10.1016/j.jpainsymman.2010.05.006 21123026

8 Lambert SD , Jones BL , Girgis A , Lecathelinais C. Distressed partners and caregivers do not recover easily: adjustment trajectories among partners and caregivers of cancer survivors . Ann Behav Med . 2012 ; 44 : 225 - 235 . 10.1007/s12160-012-9385-2 22740365

9 Kim SY , Kim SJ , Kim JM , et al Prevalence and predictors of major depressive disorder in bereaved caregivers at 6 and 13 months . Palliat Support Care . 2019 ; 17 : 300 - 305 . 10.1017/S1478951518000366 29806573

10 Applebaum AJ. Future directions for cancer caregiver research . In: Applebaum AJ , ed. Cancer Caregivers . Oxford University Press ; 2019 .

11 Boehmer U , Tripodis Y , Bazzi AR , Winter M , Clark MA. Fear of cancer recurrence in survivor and caregiver dyads: differences by sexual orientation and how dyad members influence each other . J Cancer Surviv . 2016 ; 10 : 802 - 813 . 10.1007/s11764-016-0526-7 26899851 PMC5076855

12 Hunt G , Longacre M , Kent E , Weber-Raley L. Cancer Caregiving in the U.S.: An Intense, Episodic, and Challenging Care Experience . AARP ; 2017 .

13 Lin CR , Chen SC , Chang JT , Fang YY , Lai YH. Fear of cancer recurrence and its impacts on quality of life in family caregivers of patients with head and neck cancers . J Nurs Res . 2016 ; 24 : 240 - 248 . 10.1097/jnr.0000000000000169 27509212

14 Maguire R , Hanly P , Balfe M , et al Worry in head and neck cancer caregivers: the role of survivor factors, care-related stressors, and loneliness in predicting fear of recurrence . Nurs Res . 2017 ; 66 : 295 - 303 . 10.1097/nnr.0000000000000223 28654567

15 Broxson J , Feliciano L. Understanding the impacts of caregiver stress . Prof Case Manag . 2020 ; 25 : 213 - 219 . 10.1097/ncm.0000000000000414 32453176

16 Fujinami R , Sun V , Zachariah F , Uman G , Grant M , Ferrell B. Family caregivers’ distress levels related to quality of life, burden, and preparedness . Psychooncology . 2015 ; 24 : 54 - 62 . 10.1002/pon.3562 24789500 PMC4216636

17 Dionne-Odom JN , Azuero A , Taylor RA , et al Resilience, preparedness, and distress among family caregivers of patients with advanced cancer . Support Care Cancer . 2021 ; 29 : 6913 - 6920 . 10.1007/s00520-021-06265-y 34031751 PMC9733586

18 Hancock DW , Czaja S , Schulz R. The role of preparedness for caregiving on the relationship between caregiver distress and potentially harmful behaviors . Am J Alzheimer Dis Other Dement . 2022 ; 37 : 15333175221141552 . 10.1177/15333175221141552

19 Kaddour L , Kishita N , Schaller A. A meta-analysis of low-intensity cognitive behavioral therapy-based interventions for dementia caregivers . Int Psychogeriatr . 2019 ; 31 : 961 - 976 . 10.1017/s1041610218001436 30417806

20 Hopkinson MD , Reavell J , Lane DA , Mallikarjun P. Cognitive behavioral therapy for depression, anxiety, and stress in caregivers of dementia patients: a systematic review and meta-analysis . Gerontologist . 2019 ; 59 : e343 - e362 . 10.1093/geront/gnx217 29529290

21 Verreault P , Turcotte V , Ouellet MC , Robichaud LA , Hudon C. Efficacy of cognitive-behavioural therapy interventions on reducing burden for caregivers of older adults with a neurocognitive disorder: a systematic review and meta-analysis . Cogn Behav Ther . 2021 ; 50 : 19 - 46 . 10.1080/16506073.2020.1819867 33125307

22 Werson AD , Meiser-Stedman R , Laidlaw K. A meta-analysis of CBT efficacy for depression comparing adults and older adults . J Affect Disord . 2022 ; 319 : 189 - 201 . 10.1016/j.jad.2022.09.020 36113691

23 Zhang A , Borhneimer LA , Weaver A , et al Cognitive behavioral therapy for primary care depression and anxiety: a secondary meta-analytic review using robust variance estimation in meta-regression . J Behav Med . 2019 ; 42 : 1117 - 1141 . 10.1007/s10865-019-00046-z 31004323

24 Karyotaki E , Efthimiou O , Miguel C , et al ; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration . Internet-based cognitive behavioral therapy for depression: a systematic review and individual patient data network meta-analysis . JAMA Psychiatry . 2021 ; 78 : 361 - 371 . 10.1001/jamapsychiatry.2020.4364 33471111 PMC8027916

25 Cuijpers P , Berking M , Andersson G , Quigley L , Kleiboer A , Dobson KS. A meta-analysis of cognitive-behavioural therapy for adult depression, alone and in comparison with other treatments . Can J Psychiatry . 2013 ; 58 : 376 - 385 . 10.1177/070674371305800702 23870719

26 Hans E , Hiller W. Effectiveness of and dropout from outpatient cognitive behavioral therapy for adult unipolar depression: a meta-analysis of nonrandomized effectiveness studies . J Consult Clin Psychol . 2013 ; 81 : 75 - 88 . 10.1037/a0031080 23379264

27 Hofmann SG , Wu JQ , Boettcher H. Effect of cognitive-behavioral therapy for anxiety disorders on quality of life: a meta-analysis . J Consult Clin Psychol . 2014 ; 82 : 375 - 391 . 10.1037/a0035491 24447006 PMC4029924

28 Vernooij-Dassen M , Draskovic I , McCleery J , Downs M. Cognitive reframing for carers of people with dementia . Cochrane Database Syst Rev . 2011 ; 2011 : Cd005318 . 10.1002/14651858.CD005318.pub2 22071821 PMC12536931

29 Scott JL , Dawkins S , Quinn MG , et al Caring for the carer: a systematic review of pure technology-based cognitive behavioral therapy (TB-CBT) interventions for dementia carers . Aging Ment Health . 2016 ; 20 : 793 - 803 . 10.1080/13607863.2015.1040724 25978672

30 Sun Y , Ji M , Leng M , Wang Z. Which cognitive behavioral therapy delivery formats work for depressive symptoms in dementia caregivers? - a systematic review and network meta-analysis of randomized controlled trials . J Affect Disord . 2022 ; 308 : 181 - 187 . 10.1016/j.jad.2022.04.055 35429541

31 McHugh M , Munsterman E , Cho H , Naylor MD. Effective solutions for caregivers of older adults: a review of systematic reviews . J Appl Gerontol . 2025 ; 44 : 1571 - 1583 . 10.1177/07334648241312999 39785108 PMC12238300

32 Kwon OY , Ahn HS , Kim HJ , Park KW. Effectiveness of cognitive behavioral therapy for caregivers of people with dementia: a systematic review and meta-analysis . J Clin Neurol . 2017 ; 13 : 394 - 404 . 10.3988/jcn.2017.13.4.394 29057632 PMC5653628

33 Kishita N , Hammond L , Dietrich CM , Mioshi E. Which interventions work for dementia family carers?: an updated systematic review of randomized controlled trials of carer interventions . Int Psychogeriatr . 2018 ; 30 : 1679 - 1696 . 10.1017/s1041610218000947 30017008

34 Chi NC , Han S , Lin SY , et al Resilience-enhancing interventions for family caregivers: a systematic review . Chronic Illn . 2024 ; 20 : 199 - 220 . 10.1177/17423953231174928 37259541

35 Cheng ST , Au A , Losada A , Thompson LW , Gallagher-Thompson D. Psychological interventions for dementia caregivers: what we have achieved, what we have learned . Curr Psychiatry Rep . 2019 ; 21 : 59 . 10.1007/s11920-019-1045-9 31172302 PMC6554248

36 O’Toole MS , Zachariae R , Renna ME , Mennin DS , Applebaum A. Cognitive behavioral therapies for informal caregivers of patients with cancer and cancer survivors: a systematic review and meta-analysis . Psychooncology . 2017 ; 26 : 428 - 437 . 10.1002/pon.4144 27147198 PMC5412844

37 Zhou S , Wang Y , Wang Q , Yang G , Ren H , Bao Y. A meta-analysis of the effects of cognitive behavioral therapy on quality of life and negative emotions of informal cancer caregivers . Front Psychiatry . 2022 ; 13 : 979158 . 10.3389/fpsyt.2022.979158 36506448 PMC9727093

38 El-Jawahri A , Jacobs JM , Nelson AM , et al Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: a randomized clinical trial . Cancer . 2020 ; 126 : 1758 - 1765 . 10.1002/cncr.32680 31899552 PMC7103553

39 Forst DA , Podgurski AF , Strander SM , et al NeuroCARE: a randomized controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumors . J Clin Oncol . 2024 ; 42 : 4252 - 4262 . 10.1200/jco.24.00065 39284103

40 Forst DA , Willis KD , Strander SM , et al Coping in caregivers of patients with primary malignant brain tumors: a mediation analysis of a randomized controlled trial . J Clin Oncol . 2024 ; 42 : 12110 - 12110 . 10.1200/JCO.2024.42.16_suppl.12110

41 Jacobs JM , Nelson AM , Traeger L , et al Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: identifying mechanisms of a multimodal psychosocial intervention . Cancer . 2020 ; 126 : 5337 - 5346 . 10.1002/cncr.33191 33026658 PMC7950641

42 Hong B , Yang S , Hyeon S , Kim S , Lee J. Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review . BMC Complement Med Ther . 2023 ; 23 : 360 . 10.1186/s12906-023-04186-3 37821898 PMC10566119

43 Mennin DS , Fresco DM. Emotion regulation therapy . In: Handbook of Emotion Regulation . 2nd ed. The Guilford Press ; 2014 : 469 - 490 .

44 Fresco DM , Moore MT , van Dulmen MH , et al Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering . Behav Ther . 2007 ; 38 : 234 - 246 . 10.1016/j.beth.2006.08.003 17697849

45 Ochsner KN , Gross JJ. The cognitive control of emotion . Trends Cogn Sci . 2005 ; 9 : 242 - 249 . 10.1016/j.tics.2005.03.010 15866151

46 Mennin DS , Fresco DM , O’Toole MS , Heimberg RG. A randomized controlled trial of emotion regulation therapy for generalized anxiety disorder with and without co-occurring depression . J Consult Clin Psychol . 2018 ; 86 : 268 - 281 . 10.1037/ccp0000289 29504794 PMC5841545

47 Mennin DS , Fresco DM , Ritter M , Heimberg RG. An open trial of emotion regulation therapy for generalized anxiety disorder and cooccurring depression . Depress Anxiety . 2015 ; 32 : 614 - 623 . 10.1002/da.22377 25945946 PMC4515189

48 Renna ME , Quintero JM , Soffer A , et al A pilot study of emotion regulation therapy for generalized anxiety and depression: findings from a diverse sample of young adults . Behav Ther . 2018 ; 49 : 403 - 418 . 10.1016/j.beth.2017.09.001 29704969 PMC7486678

49 Özönder Ünal I , Ordu C. Decoding caregiver burden in cancer: role of emotional health, rumination, and coping mechanisms . Healthcare . 2023 ; 11 : 2700 . 37830736 10.3390/healthcare11192700 PMC10573024

50 Cao Z , Chen Y , Zhang H. Effects of fatigue, rumination thinking, and sleep quality on hopelessness in family caregivers of cancer patients . Support Care Cancer . 2023 ; 31 : 631 . 10.1007/s00520-023-08098-3 37843601

51 O’Rourke L , Fisher PL , Campbell S , Wright A , Cherry MG. Factors associated with fear of cancer recurrence in family caregivers of cancer survivors: a systematic review . Front Psychol . 2021 ; 12 : 625654 . 10.3389/fpsyg.2021.625654 34335354 PMC8323753

52 Applebaum AJ , Panjwani AA , Buda K , et al Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress . Transl Behav Med . 2020 ; 10 : 413 - 422 . 10.1093/tbm/iby104 30395306 PMC7394488

53 Mikkelsen MB , Elkjær E , Mennin DS , et al The impact of emotion regulation therapy on emotion differentiation in psychologically distressed caregivers of cancer patients . Anxiety Stress Coping . 2021 ; 34 : 479 - 485 . 10.1080/10615806.2021.1929934 34047220 PMC8364870

54 O’Toole MS , Mennin DS , Applebaum A , et al A randomized controlled trial of emotion regulation therapy for psychologically distressed caregivers of cancer patients . JNCI Cancer Spectr . 2020 ; 4 : pkz074 . 10.1093/jncics/pkz074 32337491 PMC7050163

55 Applebaum AJ , Loschiavo M , Morgan K , et al A randomized controlled trial of emotion regulation therapy for cancer caregivers: a mechanism-targeted approach to addressing caregiver distress . Contemp Clin Trials . 2022 ; 122 : 106923 . 10.1016/j.cct.2022.106923 36115638 PMC9769581

56 Emotion Regulation Therapy for Cancer Caregivers: Targeting Mechanisms of Distress . Oxford University Press ; 2019 . 10.1093/med/9780190868567.003.0013

57 Beck JS. Cognitive Behavior Therapy: Basics and Beyond , 3 rd ed. The Guilford Press ; 2021 : xvi, 414 .

58 Zigmond AS , Snaith RP. The hospital anxiety and depression scale . Acta Psychiatr Scand . 1983 ; 67 : 361 - 370 . 10.1111/j.1600-0447.1983.tb09716.x 6880820

59 Meyer TJ , Miller ML , Metzger RL , Borkovec TD. Development and validation of the Penn state worry questionnaire . Behav Res Ther . 1990 ; 28 : 487 - 495 . 10.1016/0005-7967(90)90135-6 2076086

60 Trapnell PD , Campbell JD. Private self-consciousness and the five-factor model of personality: distinguishing rumination from reflection . J Pers Soc Psychol . 1999 ; 76 : 284 - 304 . 10.1037//0022-3514.76.2.284 10074710

61 McMillan SC. Quality of life of primary caregivers of hospice patients with cancer . Cancer Pract . 1996 ; 4 : 191 - 198 . 8900760

62 Given CW , Given B , Stommel M , Collins C , King S , Franklin S. The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments . Res Nurs Health . 1992 ; 15 : 271 - 283 . 10.1002/nur.4770150406 1386680

63 Cella D , Riley W , Stone A , et al ; PROMIS Cooperative Group . The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008 . J Clin Epidemiol . 2010 ; 63 : 1179 - 1194 . 10.1016/j.jclinepi.2010.04.011 20685078 PMC2965562

64 Bjordal K , de Graeff A , Fayers PM , et al A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC quality of life group . Eur J Cancer . 2000 ; 36 : 1796 - 1807 . 10.1016/s0959-8049(00)00186-6 10974628

65 Cohen S , Kamarck T , Mermelstein R. A global measure of perceived stress . J Health Soc Behav . 1983 ; 24 : 385 - 396 . 10.2307/2136404 6668417

66 National Survey on Drug Use and Health , Substance Abuse and Mental Health Services Administration . CAI Specifications for Programming (English Version) . Center for Behavioral Health Statistics and Quality ; 2019 .

67 Peters SA , Bots ML , den Ruijter HM , et al ; METEOR Study Group . Multiple imputation of missing repeated outcome measurements did not add to linear mixed-effects models . J Clin Epidemiol . 2012 ; 65 : 686 - 695 . 10.1016/j.jclinepi.2011.11.012 22459429

68 van Buuren S. Multiple imputation of discrete and continuous data by fully conditional specification . Stat Methods Med Res . 2007 ; 16 : 219 - 242 . 10.1177/0962280206074463 17621469

69 Becker BJ. Synthesizing standardized mean-change measures . Br J Math Stat Psychol . 1988 ; 41 : 257 - 278 . 10.1111/j.2044-8317.1988.tb00901.x

70 Marshall A , Altman DG , Holder RL , Royston P. Combining estimates of interest in prognostic modelling studies after multiple imputation: current practice and guidelines . BMC Med Res Methodol . 2009 ; 9 : 57 . 10.1186/1471-2288-9-57 19638200 PMC2727536

71 SAS Institute Inc. SAS. Cary, NC.

72 Cuijpers P , Reijnders M , Huibers MJH. The role of common factors in psychotherapy outcomes . Annu Rev Clin Psychol . 2019 ; 15 : 207 - 231 . 10.1146/annurev-clinpsy-050718-095424 30550721