Comparative Effects of Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, and Treatment-as-Usual on Depression Among People With Marital Crisis

Condition(s) studied

Investigational drug(s) / intervention(s)

Acceptance and Commitment Therapy: ACT combined with a single antidepressant. Participants randomized to the ACT arm receive an eight-week manualized group ACT program, with weekly 90-minute sessions delivered in closed groups of approximately 8 to 10 participants per group. The program is conducted in adherence to the ACT protocol developed by Hayes et al. (2012), targeting the six core processes of psychological flexibility, namely acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. To consider the program successfully completed, each participant is expected to attend at least 6 of the 8 sessions, with a maximum allowable late arrival of 10 minutes per session.

Cognitive Behavioral Therapy: CBT combined with a single antidepressant. Participants randomized to the CBT arm receive an eight-week manualized group CBT program, with weekly 90-minute sessions delivered in closed groups of approximately 8 to 10 participants per group, conducted in adherence to established cognitive behavioural therapy for depression adapted for delivery in a group format (Bieling et al., 2022). The CBT manual used in this trial is based on the validated cognitive therapy protocol for depression established by Beck, Rush, Shaw, and Emery (1979), comprising cognitive restructuring and behavioural activation, which remains the standard manualized protocol for cognitive therapy of depression and has been extensively validated in randomized controlled trials. To consider the program successfully completed, each participant is expected to attend at least 6 of the 8 sessions, with a maximum allowable late arrival of 10 minutes per session.

Study summary

This parallel three-arm, single-blind (assessor-blinded), randomized controlled trial (RCT) aims to compare the effects of ACT, CBT, and treatment-as-usual (TAU) on the severity of depressive symptoms (primary outcome), the severity of comorbid anxiety symptoms, marital satisfaction, intimacy with spouse, quality of life, and experiential avoidance (secondary outcomes) among people diagnosed with major depressive disorder (MDD) with marital crisis across four time points (T0 = baseline (pre-intervention), T1 = post-intervention (immediately after completion of the intervention, 8 weeks after its commencement), T2 = follow-up at 12 weeks after completion of the intervention, T3 = follow-up at 24 weeks after completion of the intervention).

A total of 120 MDD patients with marital crisis will be recruited from two study sites and randomized by stratified block randomization into three groups (ACT, CBT and TAU) in a 1:1:1 ratio. ACT group therapy will be conducted once a week for 8 weeks in the ACT group, while CBT group therapy once a week for 8 weeks will be carried out in the CBT group. During baseline assessment (T0), the demographic and clinical characteristics, the Chinese versions of the Beck Depression Inventory-II (BDI-II), the Generalized Anxiety Disorder 7-item scale (GAD-7), the Personal Assessment of Intimacy in Relationships (PAIR), the Dyadic Adjustment Scale (DAS), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and the Acceptance and Action Questionnaire-II (AAQ-II) will be administered to all participants. The re-administration of the BDI-II, GAD-7, PAIR, DAS, WHOQOL-BREF and AAQ-II will be carried out at T1, T2, and T3.

Eligibility

Primary outcome measure(s)

• Severity of depressive symptoms assessed by Beck Depression Inventory-II — Change of the BDI-II score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention
  The severity of depressive symptoms is measured using the Chinese version of the Beck Depression Inventory-II (BDI-II), a 21-item self-report instrument scored on a four-point scale (0 to 3) per item, generating a total score ranging from 0 to 63. Higher scores indicate greater symptom severity, with cut-off scores of 14, 20, and 29 demarcating mild, moderate, and severe depression, respectively

Trial sites (1)

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