DepressionNCT07736508
Systemic Couple Therapy for Marital Dynamics and Mental Health
A study testing Systemic Couple Therapy in people with Depression, run by Shifa Tameer-e-Millat University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Systemic Couple Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Systemic Couple Therapy for Enhancement of Marital Dynamics and Mental Health Among Individuals With Depression: A Mixed Method Approach
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:
Read more
- 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)
- Conditions
- Depression
- Being tested
- Systemic Couple Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Couple TherapyBehavioural
Systemic Couple Therapy for Depressive Sample
| Study group | Role | What they receive |
|---|---|---|
| Systemic Couple Therapy | Experimental | Systemic Couple Therapy Receives: Behavioral: Systemic Couple Therapy |
| TAU | No intervention | Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Depression severity will be measured using the Patient Health Questionnaire-9, a 9-item self-report questionnaire assessing the frequency of depressive symptoms experienced during the previous two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).
Measured: 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
Marital communication is defined as the verbal and nonverbal sharing of information among spouses. Marital communication will be assessed using the Dyadic Communication Assessment Scale. The scale consists of 16 items, each rated on a 5-point Likert scale ranging from 1 (Rarely) to 5 (Always). Total scores range from 16 to 80, with higher scores indicating better and more effective marital communication. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).
Measured: 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
Dyadic coping is the process by which couple assist each other when one or both are under stress. Dyadic coping will be assessed using the Dyadic Coping Inventory. The inventory consists of 37 items rated on a 5-point Likert scale ranging from 1 (very rarely) to 5 (very often). Total scores range from 37 to 185, with higher scores indicating more effective dyadic coping between partners. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).
Measured: 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
Interpersonal relationships will be assessed using the Interpersonal Relationships Rating Scale. The scale consists of 18 items rated on a 5-point Likert scale ranging from 1 (completely inconsistent) to 5 (completely consistent). Total scores range from 18 to 90, with higher scores indicating better interpersonal relationships and interpersonal functioning. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).
Measured: 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
Mental health will be measured using the Mental Health Inventory-38, a 38-item self-report questionnaire that assesses overall psychological well-being and psychological distress experienced during the previous month. Responses are recorded using 5-point or 6-point response options depending on the item, and scores are summed to produce a Mental Health Index ranging from 38 to 226. Higher scores indicate better overall mental health, reflecting greater psychological well-being and lower psychological distress. Assessments will be conducted at baseline (August) after enrollment, post-intervention (8-weeks )(September), and the 3-month follow-up (December).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamkeen Saleem, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736508
- Sponsor's protocol ID
- 484-25
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Couple Therapy for Enhancement of Marital Dynamics and Mental Health Among Individuals With Depression: A Mixed Method Approach
- ClinicalTrials.gov ID
- NCT07736508
- Acronym / sponsor ID
- 484-25
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Couple Therapy | Experimental | Behavioral: Systemic Couple TherapySystemic Couple Therapy |
| TAU | No intervention | –Treatment As Usual |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
- • Participants with severe depression, psychosis, bipolar disorder, or active substance use disorder will be excluded from the study due to potential interference with therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic Couple TherapySystemic Couple Therapy for Depressive Sample | Behavioural | Systemic Couple Therapy |
Primary outcome
Relationship Quality
Time frame: 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.
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).
5 secondary outcomes
Depression
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic Couple Therapy in people with Depression, run by Shifa Tameer-e-Millat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamkeen Saleem, Phd (923325412281, tamkeen.dcp@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Quality (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.