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

NCT07808021 | Not Yet Recruiting DMC

• 1 other identifier: UniSZA/1/9/2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression - Major Depressive Disorder; Anxiety; Marital Conflict

Keywords

randomized controlled trial; depression; marital conflict; anxiety; intention-to-treat analysis

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (5)

• Severity of comorbid anxiety symptoms assessed by 7-item Generalized Anxiety Disorder questionnaire

  Change in the GAD-7 score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention

• The degree of marital satisfaction assessed by the Dyadic Adjustment Scale (DAS)

  Change in the DAS score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention

• The degree of spousal intimacy assessed with the Personal Assessment of Intimacy in Relationships (PAIR)

  Change in the PAIR score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention

• The degree of quality of life assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)

  Change in the WHOQOL-BREF score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention

• The degree of experiential avoidance assessed by the Acceptance and Action Questionnaire-II (AAQ-II)

  Change in the AAQ-II score from baseline, 8 weeks at completion of intervention, 12 weeks after completion of intervention and 24 weeks after completion of intervention

Study Arms (3)

Acceptance and commitment therapy

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy

Cognitive behavioral therapy

ACTIVE COMPARATOR

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. 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.

Behavioral: Cognitive Behavioral Therapy

Treatment-As-Usual Control Group

NO INTERVENTION

Participants randomized to the TAU group continue the antidepressant regimen prescribed by their treating psychiatrist prior to study enrollment, maintained at the same dose throughout the study period. These participants attend routine psychiatric follow-up visits at the study site approximately once every four weeks, with each visit lasting approximately 15 to 20 minutes. The visits are conducted by board-certified psychiatrists who are not involved in the delivery of the ACT or CBT interventions and are focused on monitoring depressive symptoms, evaluating medication adherence and side effects, and providing supportive but non-directive communication. No structured psychotherapy, no manualized treatment components, and no group sessions are delivered to the TAU group.

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Acceptance and commitment therapy

Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive behavioral therapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Currently taking a single antidepressant medication for a minimum of two weeks. Rather than being required to remain on an unchanged dose, participants agree to have their antidepressant regimen managed by their treating psychiatrist according to clinical need for the duration of the study; any change in medication or dose is documented and included as a time-varying covariate in the analysis.

You may not qualify if:

• 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.
• Current exposure to active intimate partner violence or domestic abuse. This is screened at the face-to-face assessment using a brief standardized instrument, and it is applied to safeguard participant safety during the disclosure of marital distress in the group setting. Individuals who screen positive are not enrolled and are referred to appropriate local domestic-violence support services.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Universiti Sultan Zainal Abidin: collaborator

Study Sites (1)

Yunfu City Yuncheng District People's Hospital

Yunfu, Guangdong, 526060, China

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mohammad Farris Iman Leong Bin Abdullah, Doctor of Psychiatry

  Faculty of Medicine, Universiti Sultan Zainal Abidin

  STUDY CHAIR

Central Study Contacts

Shaofang Liang, Masters

CONTACT

+8613822611205; liangshaofangly@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)