Efficacy of digital cognitive behavioral therapy for insomnia in hypnotic reduction among patients with insomnia: A randomized controlled trial.

BACKGROUND

This study evaluated the efficacy and adherence of digital cognitive behavioral therapy for insomnia (dCBT-I) for hypnotic medication reduction in patients with insomnia disorder comorbid with anxiety and depressive symptoms who require long-term pharmacotherapy.

METHODS

A single-center, randomized, double-blind, parallel-group trial was conducted at the Brain Hospital of Inner Mongolia Autonomous Region. A total of 112 adult outpatients who met the DSM-5 criteria for insomnia comorbid with anxiety and depressive symptoms were enrolled. Participants were randomly assigned (1:1) to receive either 4 weeks of dCBT-I (n = 56) or digital sleep hygiene education (dSHE; n = 56) as an active control. For participants who showed sleep improvement, a gradual tapering protocol was implemented for hypnotic medications at a rate of 25 % reduction from the initial dose per week. Dosages of antidepressants and hypnotics were converted to fluoxetine equivalents and alprazolam equivalents, respectively. The medication reduction rate (derived from the alprazolam equivalents dosage) and ISI scores were the primary outcomes, assessed at weeks 4, 8, and 12.

RESULTS

A total of 76 participants (42 in the dCBT-I group and 34 in the dSHE group) completed the 4-week intervention, yielding an overall adherence rate of 74. 5 %. Significant between-group differences favoring dCBT-I over dSHE in hypnotic medication reduction were observed at week 4 (β = -0.17, t = -2.17, P < 0.05), week 8 (β = -0.21, t = -2.70, P < 0.01), and week 12 (β = -0.18, t = -2.41, P < 0.05).

CONCLUSION

dCBT-I represents an effective and adherence-friendly treatment model for reducing hypnotic medication use in patients with insomnia comorbid with anxiety and depressive symptoms.