Trials · 2023
Eye movement desensitization and processing for adolescents with major depressive disorder: study protocol for a multi-site randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Paauw C C, de Roos C, Koornneef M G T, Elzinga B M, Boorsma T M, Verheij M A, Dingemans A E
Аннотация
BACKGROUND: Major depressive disorder (MDD) is one of the most common mental disorders in adolescence carrying a serious risk of adverse development later in life. Extant treatments are limited in effectiveness and have high drop-out and relapse rates. A body of literature has been published on the association between distressing/ traumatic experiences and development and maintenance of MDD, but the effectiveness of a trauma-focused treatment approach for MDD has hardly been studied. This study aims to determine the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy as stand-alone intervention in adolescents diagnosed with MDD.
METHODS: This study will be a randomized controlled trial with two conditions: (1) EMDR treatment (6 sessions) and (2) waiting list condition (WL: 6 weeks, followed by EMDR treatment). First, participants receive a baseline measure after which they will be randomized. Participants will be assessed post-intervention after which the WL participants will also receive six EMDR sessions. Follow-up assessments will be conducted at 3 and 6 months follow-up.
STUDY POPULATION: In total, 64 adolescents (aged 12-18) diagnosed with a major depressive disorder (DSM-5) and identified memories of at least one distressing or traumatic event related to the depressive symptomatology will be included. Main study parameters/endpoints: Primary outcome variables will be the percentage of patients meeting criteria for MDD classification, and level of depressive symptoms. Secondary outcome measures include symptoms of PTSD, anxiety, and general social-emotional problems. At baseline, family functioning and having experienced emotional abuse or neglect will be assessed to explore whether these factors predict post-treatment outcome.
DISCUSSION: With the present study, we aim to investigate whether EMDR as a trauma-focussed brief intervention may be effective for adolescents with a primary diagnosis of MDD. EMDR has been proven an effective treatment for traumatic memories in other disorders. It is hypothesized that traumatic memories play a role in the onset and maintenance of depressive disorders. Particularly in adolescence, early treatment of these traumatic memories is warranted to prevent a more chronic or recurrent course of the disorder.
TRIAL REGISTRATION: International Clinical Trial Registry Platform (ICTRP): NL9008 (30-10-2020).
METHODS: This study will be a randomized controlled trial with two conditions: (1) EMDR treatment (6 sessions) and (2) waiting list condition (WL: 6 weeks, followed by EMDR treatment). First, participants receive a baseline measure after which they will be randomized. Participants will be assessed post-intervention after which the WL participants will also receive six EMDR sessions. Follow-up assessments will be conducted at 3 and 6 months follow-up.
STUDY POPULATION: In total, 64 adolescents (aged 12-18) diagnosed with a major depressive disorder (DSM-5) and identified memories of at least one distressing or traumatic event related to the depressive symptomatology will be included. Main study parameters/endpoints: Primary outcome variables will be the percentage of patients meeting criteria for MDD classification, and level of depressive symptoms. Secondary outcome measures include symptoms of PTSD, anxiety, and general social-emotional problems. At baseline, family functioning and having experienced emotional abuse or neglect will be assessed to explore whether these factors predict post-treatment outcome.
DISCUSSION: With the present study, we aim to investigate whether EMDR as a trauma-focussed brief intervention may be effective for adolescents with a primary diagnosis of MDD. EMDR has been proven an effective treatment for traumatic memories in other disorders. It is hypothesized that traumatic memories play a role in the onset and maintenance of depressive disorders. Particularly in adolescence, early treatment of these traumatic memories is warranted to prevent a more chronic or recurrent course of the disorder.
TRIAL REGISTRATION: International Clinical Trial Registry Platform (ICTRP): NL9008 (30-10-2020).