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.
Meets DSM-5-TR diagnostic criteria for major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI) structured clinical interview (American Psychiatric Association, 2022).
Beck Depression Inventory-II (BDI-II) total score of 20 or above, indicating moderate to severe depressive symptoms (Beck et al., 1996).
Dyadic Adjustment Scale (DAS) total score of 97 or below, operationally defining marital crisis (Spanier, 1976).
Age between 20 and 60 years.
Current diagnosis of symptomatic bipolar mood disorder or psychotic disorder which would interfere with their ability to answer questionnaires and participate in the study.
History of substance abuse or acute alcohol use disorder.
Prior receipt of any structured psychotherapy before study enrollment.
Severe physical illness or cognitive impairment that would prevent meaningful participation in group therapy sessions or completion of assessment instruments.
Parallel
Acceptance and Commitment Therapy
BehavioralACT 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
BehavioralCBT 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.
Severity of depressive symptoms assessed by Beck Depression Inventory-II
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
Severity of comorbid anxiety symptoms assessed by 7-item Generalized Anxiety Disorder questionnaire
The severity of comorbid anxiety symptoms is measured using the Chinese version of the Generalized Anxiety Disorder 7-item scale (GAD-7), a self-report instrument with each item rated on a four-point scale from 0 (not at all) to 3 (nearly every day), generating a total score ranging from 0 to 21, with cut-off scores of 5, 10, and 15 indicating mild, moderate, and severe anxiety, respectively
The degree of marital satisfaction assessed by the Dyadic Adjustment Scale (DAS)
The degree of marital satisfaction is measured using the Chinese version of the Dyadic Adjustment Scale (DAS), a 32-item self-report instrument generating a total score ranging from 0 to 151, in which higher scores indicate better marital adjustment. A total score of 97 or below is applied as the operational cut-off for marital crisis in this study, serving as one of the inclusion criteria for participant enrollment
The degree of spousal intimacy assessed with the Personal Assessment of Intimacy in Relationships (PAIR)
The degree of relationship intimacy is measured using the Chinese version of the Personal Assessment of Intimacy in Relationships (PAIR) inventory, a 36-item self-report instrument with responses rated on a five-point scale from 1 (strongly disagree) to 5 (strongly agree), in which higher scores within each facet indicate greater intimacy in that domain of the relationship.
The degree of quality of life assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The degree of quality of life is measured using the Chinese version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF), a 26-item self-report instrument rated on a five-point scale per item, in which raw domain scores are transformed onto a 0 to 100 scale for ease of comparison, with higher scores indicating better quality of life within each domain.
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Universiti Sains Malaysia
Lead sponsor
Universiti Sultan Zainal Abidin
Sponsor institution
Universiti Sultan Zainal Abidin
Collaborator
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