NCT07748845

Brief Summary

This study aimed to evaluate the effect of Gottman couple therapy program targeted for discordant couples struggling with the negative impact of depression of the female partner and compare between the outcome in case of usual treatment of depression and the outcome with applying Gottman program added to the usual treatment of depression in the female partner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
Last Updated

August 6, 2026

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

July 31, 2026

Last Update Submit

July 31, 2026

Conditions

Keywords

Gottman couple Therapyfemale partnersMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • severity of depression by Hamilton Depression Rating Scale

    Hamilton Depression Rating Scale (HDRS): The questionnaire is designed for adults and is used to rate severity of depression by probing mood, feeling of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss and somatic symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. The total score was calculated by summation of the first seventeen items. The severity of depression was divided into 4 categories as follows: 0- 7are considered as normal patients, 8-16 suggesting mild depression, 17-23 suggesting moderate depression and scores over 24 indicating severe depression.

    12 months

Secondary Outcomes (1)

  • Satisfaction score by ENRICH marital satisfaction scale

    12 months

Study Arms (2)

Group 1: receive Gottman couple therapy program

EXPERIMENTAL

Group 1: receive Gottman couple therapy program with their partners, in addition to the usual treatment of depression

Other: Gottman couple therapy

Group 2: undergo treatment as usual for depression.

PLACEBO COMPARATOR

Group 2: will undergo treatment as usual for depression.

Other: treatment as usual for depression

Interventions

Gottman Method for Couple Therapy is based on "sound relationship house" theory that proposes seven relational processes: 1. Build love maps. A love map is a road map of one's partner's inner world, built by asking open-ended questions. 2. Build the fondness and admiration system by expressing affection and respect in small, everyday moments. 3. Turn toward instead of away or against by noticing and responding to a partner's bids for emotional connection. 4. Allow positive sentiment override, which results in not taking negative partner actions personally, or give the partner the benefit of the doubt. 5. Take a two-pronged approach toward managing conflict by (a) using a gentle approach in presenting complaints, accepting influence, physiological soothing, and compromise, and (b) establishing a dialogue with perpetual problems that examines and honors the existential dreams of both partners within the conflict. 6. Honor one another's individual, and perhaps unshared, life dreams.

Group 1: receive Gottman couple therapy program

Group 2: undergo treatment as usual for depression

Group 2: undergo treatment as usual for depression.

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of partners: between 20 and 60 years
  • Married for at least 1 year.
  • Female partners meet the diagnostic criteria for major depressive disorder with a score of Hamilton Depression Rating Scale above 7
  • Discordant couples, as indicated by a score of 45 or lower on ENRICH Marital Satisfaction Scale.
  • Commitment to participate in the therapy sessions.

You may not qualify if:

  • Male partners who meet the diagnostic criteria for a depressive disorder.
  • Co-morbid psychiatric illness for any partner
  • Couples if one or both disclosed an act of infidelity or more than two acts of physical aggression in the preceding 3 months.
  • Couples on the verge of divorce
  • Co-morbid serious medical or neurological disorder (stroke, epilepsy, traumatic brain injury, ..etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 6, 2026

Study Start

April 30, 2023

Primary Completion

May 30, 2024

Study Completion

December 30, 2024

Last Updated

August 6, 2026

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations