- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082089
Divorce Adjustment Program for Women
A Structured and Empirically Validated Multidimensional Intervention Program to Improve Postdivorce Adjustment and Psychological Well-Being for Divorced Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Considering the current pattern of rising divorce rates in all over the world, multi-dimensional, culturally-sensitive and well-structured interventions available for people in the post-divorce period has crucial importance in clinical practice. The divorce adjustment program (DAP) is such an group intervention that is designed in the previous stage of this study to improve the level of postdivorce adjustment and psychological well-being.
The main purpose of this study is to test the potential effectiveness of the DAP to be delivered in an online group format for Turkish women who might undergo a more challenging adaptation process than that of men as indicated by the relevant literature. The DAP is a 5-module intervention for women without children and has an extra children-focused module, making the program 6 modules for women with children.
Since the DAP has not been used and/or tested before, this study will be designed as a pilot RCT in which the program will be implemented in an online group format to Turkish divorced women reporting adjustment difficulties (as determined by having scores on the Fisher Divorce Adjustment Scale-Short Form [FDAS-SF] below the average that of reported in the Turkish adaptation study). The potential effectiveness of the DAP will be tested compared to a wait-list control group (with delayed intervention). On taking baseline assessments, eligible 60 participants with children and 60 participants without children will separately be randomized to either the experimental DAP group (n = 30 for women with children; n = 30 for women without children) or to the wait-list control group (n = 30 for women with children; n = 30 for women without children). If the time gap between baseline assessment and the first DAP session exceeds 1-week period, the pre-intervention assessments will be recurred. The effectiveness of the program will be evaluated by means of various measurements to be taken before the intervention, immediately after the completion of the program and at 1-month and 3-month follow-ups. All divorced women including drop-outs will be invited to outcome assessments. After completion of the follow-up assessment, the wait-list participants will be given opportunity to choose either participation to the DAP or receiving booklets including detailed information about the DAP content. The primary outcome measure will be divorce adjustment score and depression, anxiety, stress, life satisfaction, psychological well-being, and ego strength measures will be the secondary outcomes.
The feasibility of the program will be evaluated by assessing the percentages of attendance to the sessions, drop-out rates and qualitative assessments at the end of each session, as well as at the end of the program.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adviye E Yılmaz-Samancı, PhD
- Phone Number: 905326500674
- Email: esin.yilmaz@deu.edu.tr
Study Contact Backup
- Name: Zeynep Akyüz, Phd(c)
- Phone Number: 905392118809
- Email: zeynep.akyuz@omu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being legally divorced
- Adjustment difficulties to divorce as indicated by having a FDAS-SF score of 98 or below for those with children and 94 or below for those without children (these scores are the average scores determined in the FDAS-SF Turkish adaptation study)
- Not being remarried or involved in a current romantic relationship
- Not receiving concurrent psychotherapy
Exclusion Criteria (as determined by the Diagnostic and Statistical Manual-5 [DSM-5] Level 1 Cross-Cutting Symptom Measure and a confirmatory telephone screening with the eligible participants):
- Substance use problems
- Suicidal thoughts
- Psychotic symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postdivorce Intervention Program
The experimental arm will receive the 5- or 6-session online group intervention program developed for divorced women.
|
This is a brief group intervention program for divorced women.
It consists of 6 sessions for participants with children and 5 sessions for participants without children.
Each session lasts approximately 2.5-3 hours focusing on one of the difficulties experienced by women after divorce (i.e., self-perception, emotions and emotion regulation, social problems, family-related problems, problems with ex-spouse and children (for participants with children)).
In this study, the DAP will be implemented in online format.
|
|
No Intervention: Wait List and Delayed Intervention
In this arm, participants in the wait list control group will complete outcome measures without the intervention program being implemented.
After the post intervention assessments are completed, this group will receive either the online intervention program or booklets including detailed information about the program, depending on their preference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fisher Divorce Adjustment Scale-Short Form (FDAS-SF)
Time Frame: Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
The FDAS-SF is a 25-item measure of postdivorce adjustment in terms of grief reactions, disentanglement from the relationship, anger, trust and intimacy, and self-worth.
Items are scored as 5 (always) to 1 (never), providing a range between 25 to 125.
Higher scores indicate higher levels of adjustment to divorce.
|
Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Depression Anxiety Stress Scale-21 (DASS-21)
Time Frame: Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
It is a 21-item psychological distress measure assessing the presence and severity of symptoms of depression, anxiety and stress as separate components.
The items are rated on a 4-point scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time).
Since the DAS-21 is a shorter version of the 42 item DASS, the scores should be multiplied by 2 for calculating the final score of the DASS-21 subscales.
The ratings can be classified as normal, mild, moderate, severe, and extremely severe.
|
Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
|
The Satisfaction With Life Scale (SWLS)
Time Frame: Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
The SWLS is a 5-item measure of an individual's judgment of satisfaction with life as a whole.
The items scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree), revealing a range between 5 to 35.
Higher scores indicate higher levels of life satisfaction.
|
Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
|
Psychological Well-Being Scale (PWBS)
Time Frame: Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
The PWBS is a 8-item scale developed to evaluate socio-psychological well-being.
Items are scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree).
The total score of the PWBS ranges between 8 to 56 and higher scores indicate higher levels of psychological well-being.
|
Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
|
The Ego-Resiliency Scale (ERS)
Time Frame: Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
It is a 14-item scale that aims to assess the ability to adapt to stress and adversity.
Items are scored on a 4-point Likert-scale ranging from 1 (Does not apply at all) to 4 (Applies very strongly).
Higher scores indicate higher levels of psychological resilience.
|
Change from baseline assessment, at 1 week post-intervention assessment (6-7 weeks after baseline), change from post-assessment at 1 month post-intervention assessment (2.5-3 months after baseline), and change from at 3 month post intervention assessment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 218K458
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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