NCT07808021Not yet recruiting
Comparative Effects of Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, and Treatment-as-Usual on Depression Among People With Marital Crisis
Comparative Effects of Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, and Treatment-as-Usual on Depression and Its Related Psychosocial Issues Among People With Marital Crisis in China
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Universiti Sains Malaysia
- Diseases
- Depression
- NCT number
- NCT07808021
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Jan 2027 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of any structured psychotherapy before study enrollment.
Other illness
- 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.
- Severe physical illness or cognitive impairment that would prevent meaningful participation in group therapy sessions or completion of assessment instruments.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yunfu City Yuncheng District People's Hospital Coordinator of this site? Confirm its status | Yunfu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.