- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07736508
Systemic Couple Therapy for Marital Dynamics and Mental Health
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:
- 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)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Tamkeen Saleem, Phd
- Numer telefonu: 923325412281
- E-mail: tamkeen.dcp@stmu.edu.pk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Inclusion criteria
- 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.
Exclusion Criteria:
• 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Systemic Couple Therapy
|
Systemic Couple Therapy for Depressive Sample
|
|
Brak interwencji: TAU
Treatment As Usual
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relationship Quality
Ramy czasowe: 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).
|
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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Depression
Ramy czasowe: 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.
|
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).
|
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
Ramy czasowe: 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 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).
|
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
Ramy czasowe: 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 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).
|
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
Ramy czasowe: 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 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).
|
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
Ramy czasowe: 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 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).
|
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.
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 484-25
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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