跳至主要内容
临床试验/NCT06082089
NCT06082089尚未招募不适用

A Structured and Empirically Validated Multidimensional Intervention Program to Improve Postdivorce Adjustment and Psychological Well-Being for Divorced Women

Dokuz Eylul University0 个研究点目标入组 120 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Fisher Divorce Adjustment Scale-Short Form (FDAS-SF)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •(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

研究组 & 干预措施

Postdivorce Intervention Program

Experimental

The experimental arm will receive the 5- or 6-session online group intervention program developed for divorced women.

干预措施: Divorce Adjustment Program (DAP) (Behavioral)

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.

结局指标

主要结局

Fisher Divorce Adjustment Scale-Short Form (FDAS-SF)

时间窗: 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.

次要结局

  • The Depression Anxiety Stress Scale-21 (DASS-21)(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)(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)(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)(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adviye Esin Yılmaz

Professor, Clinical Psychologist

Dokuz Eylul University

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