NCT07736508

Brief Summary

The goal of this clinical trial (randomized controlled trial within a mixed-method study) is to learn whether Systemic Couple Therapy (SCT) can treat depression and improve relational functioning in married couples where at least one partner is experiencing mild to moderate depression and relational distress. The main questions it aims to answer are:

  • Does Systemic Couple Therapy improve relationship quality, marital communication, dyadic coping, interpersonal functioning, and overall mental health?
  • Does Systemic Couple Therapy reduce depressive symptoms compared to Treatment-as-Usual (TAU)? Researchers will compare Systemic Couple Therapy (intervention group) with Treatment-as-Usual (control group) to see if SCT leads to greater improvements in mental health and relational outcomes and greater reduction in depression. Participants will:
  • Complete standardized psychological assessments at baseline, post-treatment (8 weeks), and 3-month follow-up
  • Participate in 8 weekly Systemic Couple Therapy sessions (intervention group)
  • Receive Treatment-as-Usual such as routine couple therapy services or medication (control group)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable depression

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 19, 2026

Last Update Submit

July 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship Quality

    Relationship quality will be measured using the Relationship Quality Scale, a 9-item self-report questionnaire assessing participants' perceptions of the quality of their current relationship. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 9 to 45, with higher scores indicating better relationship quality. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

Secondary Outcomes (5)

  • Depression

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

  • Marital Communication

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

  • Dyadic coping

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

  • Interpersonal relationships

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

  • Mental Health

    Assessed at baseline (after enrollment and prior to intervention), immediately after completion of the 8-week intervention, and 3 months after completion of the intervention.

Study Arms (2)

Systemic Couple Therapy

EXPERIMENTAL

Systemic Couple Therapy

Behavioral: Systemic Couple Therapy

TAU

NO INTERVENTION

Treatment As Usual

Interventions

Systemic Couple Therapy for Depressive Sample

Systemic Couple Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participant must be 18 years or older to participate in the study.
  • At least one partner must meet the diagnostic criteria for depression (mild to moderate) as defined by the DSM-5 TR.
  • Participants must be married for at least a year to ensure adequate context for systemic couple therapy.
  • Both partners must agree to participate in the study, showing their willingness to engage in the intervention and complete all required assessments.

You may not qualify if:

  • Participants with severe depression, psychosis, bipolar disorder, or active substance use disorder will be excluded from the study due to potential interference with therapy.
  • Participants currently engaged in ongoing individual psychotherapy during the study period will be excluded to avoid confounding treatment effects.
  • Additionally, couples will be excluded if there is presence of domestic violence or abuse, as identified during the initial screening or clinical interview, to ensure participant safety.
  • Couple who will be undergoing legal separation or divorce proceedings will not be eligible to participate, as the focus of the systemic couple therapy is relational commitment and stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Tamkeen Saleem, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 30, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07