DivorcedNCT06082089
Divorce Adjustment Program for Women
A study testing Divorce Adjustment Program (DAP) in people with Divorced and Adjustment Reaction, run by Dokuz Eylul University.
Trial summary
This study is the randomized controlled trial (RCT) part of a broader project aiming to develop and evaluate the effectiveness and feasibility of a structured, culture-sensitive brief divorce adjustment program (DAP) for women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Divorced, Adjustment Reaction
- What is being tested?
- Divorce Adjustment Program (DAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Structured and Empirically Validated Multidimensional Intervention Program to Improve Postdivorce Adjustment and Psychological Well-Being for Divorced Women
This study is the randomized controlled trial (RCT) part of a broader project aiming to develop and evaluate the effectiveness and feasibility of a structured, culture-sensitive brief divorce adjustment program (DAP) for women. The present pilot RCT will be the first to test the potential effectiveness of the DAP to be delivered in an online group format in comparison to a wait-list control group. The feasibility of the program will be evaluated considering 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.
Read the 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.
- Conditions
- Divorced, Adjustment Reaction
- Being tested
- Divorce Adjustment Program (DAP)
- Keywords
- divorce, postdivorce adjustment, psychological well-being, intervention program
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divorce Adjustment Program (DAP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Postdivorce Intervention Program | Experimental | The experimental arm will receive the 5- or 6-session online group intervention program developed for divorced women. Receives: Behavioral: Divorce Adjustment Program (DAP) |
| Wait List and Delayed Intervention | No 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 being measured
The primary outcome is the main question the study is designed to answer.
Fisher Divorce Adjustment Scale-Short Form (FDAS-SF)
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.
Measured: 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 outcomes (4)
The Depression Anxiety Stress Scale-21 (DASS-21)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DivorcedStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Adviye Esin Yılmaz, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082089
- Sponsor's protocol ID
- 218K458
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured and Empirically Validated Multidimensional Intervention Program to Improve Postdivorce Adjustment and Psychological Well-Being for Divorced Women
- ClinicalTrials.gov ID
- NCT06082089
- Acronym / sponsor ID
- 218K458
- Conditions
- Divorced, Adjustment Reaction
- Keywords
- divorce, postdivorce adjustment, psychological well-being, intervention program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Oct 2023 (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.
This study is the randomized controlled trial (RCT) part of a broader project aiming to develop and evaluate the effectiveness and feasibility of a structured, culture-sensitive brief divorce adjustment program (DAP) for women. The present pilot RCT will be the first to test the potential effectiveness of the DAP to be delivered in an online group format in comparison to a wait-list control group. The feasibility of the program will be evaluated considering 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postdivorce Intervention Program | Experimental | Behavioral: Divorce Adjustment Program (DAP)The experimental arm will receive the 5- or 6-session online group intervention program developed for divorced women. |
| Wait List and Delayed Intervention | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Divorce Adjustment Program (DAP)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. | Behavioural | Postdivorce Intervention Program |
Primary outcome
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.
4 secondary outcomes
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
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
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Divorce Adjustment Program (DAP) in people with Divorced and Adjustment Reaction, run by Dokuz Eylul 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adviye E Yılmaz-Samancı, PhD (905326500674, esin.yilmaz@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 13 Oct 2023.