Application Of Cognitive Behavior Therapy-Based Intervention On Psychological Distress And Coping Skills Among Women With PCOS: A Randomized Controlled Trial

Last registered on January 16, 2025

Pre-Trial

Trial Information

General Information

Title
Application Of Cognitive Behavior Therapy-Based Intervention On Psychological Distress And Coping Skills Among Women With PCOS: A Randomized Controlled Trial
RCT ID
AEARCTR-0014402
Initial registration date
September 20, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 26, 2024, 12:28 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
January 16, 2025, 8:35 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Primary Investigator

Affiliation
National University of Medical Sciences

Other Primary Investigator(s)

PI Affiliation
National University of Medical Sciences

Additional Trial Information

Status
On going
Start date
2024-08-19
End date
2025-01-25
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Background: Polycystic Ovarian Syndrome (PCOS) is an endocrine disorder effecting up-to 8-13% of women during their reproductive age. Along with health-related concerns, PCOS impacts the emotional and psychological well-being of individuals, leading to symptoms such as body image concerns, low self-esteem, and psychological distress related to physical symptoms (Azizi & Elyasi, 2017; Dewani et al., 2023). In addressing these challenges, the effectiveness of coping skills emerges as a crucial factor. Effective strategies, such as problem-focused coping, can mitigate stress and enhances quality of life (Morshedi et al., 2021), whereas maladaptive strategies, like escape-avoidance are linked to increased psychological distress, greater interpersonal sensitivity and social difficulties (Ding et al., 2021). Despite incredible advancements in treatment of endocrine disorders, little is known about causes and consequences of PCOS, which limits our understanding of its psychological management. To address this gap, the present study will provide insights into CBT-based intervention for PCOS and examine its effectiveness.
Objectives: The study will focus on managing psychological distress and developing effective coping skills (primary outcomes); and improving body image, self-esteem, interpersonal sensitivity and PCOS related quality of life (secondary outcomes).
Research Design: Young women diagnosed with PCOS (N= 46) aged 20-39 years will be recruited for the study. The study will be a randomized controlled trial, therefore, the participants will be divided equally into an experimental group (N=23) and a waiting list group (N=23). The study will be divided into three phases; pretest, intervention, and post-test. Participants in both groups will be administered in the pretest and post-test. However, the intervention will be given only to the experimental group. The participants (N=46) will be asked to fill Depression Anxiety Stress Scale-21 (Lovibond & Lovibond, 1995), Brief-Coping Orientation to Problems Experiences Inventory (Carver, 1997), Body Self-Image Questionnaire Short-Form (Rowe, 2005), Rosenberg Self-esteem Scale (Rosenberg, 1997), Interpersonal Sensitivity Measure (Boyce & Parker, 1989) and Polycystic Ovarian Syndrome Quality of Life Scale (Williams et al., 2018) during pretest and post-test. The intervention phase will comprise of 12 sessions which will be divided across 6-weeks,and will be a CBT-based intervention plan.
Statistical analysis: IBM-SPSS-26 will be utilized to assess the efficacy of a CBT-based intervention plan for both primary and secondary outcomes. The study will employ t-test to confirm the study hypotheses.
Anticipated Results & Significance: The study is expected to show significant improvement in psychological distress and coping skills among women with PCOS after CBT-based intervention, with positive effects on secondary variables. These results will provide empirical evidence supporting role of CBT in managing PCOS, promoting holistic treatment approaches that address both the psychological and physical aspects of PCOS
External Link(s)

Registration Citation

Citation
Altaf, Kishwar and Muhammad Rizwan. 2025. "Application Of Cognitive Behavior Therapy-Based Intervention On Psychological Distress And Coping Skills Among Women With PCOS: A Randomized Controlled Trial." AEA RCT Registry. January 16. https://doi.org/10.1257/rct.14402-2.1
Experimental Details

Interventions

Intervention(s)
Participants in the experimental group will undergo CBT-based intervention for a duration of 6 weeks. A brief description of the intervention plan is as follows:
12-session CBT-based Intervention (Beck, 1979). The goal of CBT-based intervention in the present research is to enable the participants to reduce psychological distress and develop effective coping skills (primary outcomes) and to improve body image, self-esteem, interpersonal sensitivity and PCOS-related quality of life (secondary outcomes). Participants of the present research will undergo 6-weeks CBT-based Intervention sessions (two sessions per week). These sessions will be designed to cover psycho-education; management of depression, anxiety, and stress; & developing effective coping skills. Each session will be of 45 minutes and will be taken one-to-one with the participants. The researcher will use a designed CBT-based intervention plan during the session. However, the participants will be facilitated through handouts and worksheets.
Intervention (Hidden)
Week # Session # Tasks & activities Homework
01 01 Psycho-education: discuss the symptoms, causes and effects of PCOS; intro to psychological distress and coping skills Self-monitoring thoughts chart
02 Introduction to CBT: CBT principles, ABC model, deep breathing mood and stress diary, deep breathing, self-monitoring thoughts chart
02 03 Automatic thoughts: information and identification of automatic thoughts, thought record form thought record form, deep breathing, mood & stress diary
04 Cognitive distortions: introduction and identification of cognitive distortions
Practicing PMRT cognitive distortions worksheet, progressive muscle relaxation technique, mood & stress diary
03 05 Cognitive restructuring: practice disputing negative thoughts
Behavioral activation: Engage in pleasurable and meaningful activities behavioral activation worksheets, mood & stress diary, PMRT
06 Coping skills: introducing different types of coping, practicing emotion focused coping (journalling & positive self-affirmations) journalling, behavioral activation worksheet, mood & stress diary, PMRT
04 07 Problem focused coping: problem-solving model, practice problem-solving steps journalling, behavioral activation worksheet, mood & stress diary
08 Practicing problem solving techniques problem solving worksheets, journalling, behavioral activation worksheet, mood & stress diary
05 09 Practicing problem solving techniques problem solving worksheets, journalling, behavioral activation worksheet, mood & stress diary
10 Stress management: introduction to stress management and Identification of stressors stressors worksheet, problem solving worksheet, journalling
06 11 Practicing stress management techniques stress management, problem solving worksheets, journalling, mood & stress diary
12 Reviewing all activities, Summarizing, providing handouts, reflect on progress
Intervention Start Date
2024-12-16
Intervention End Date
2025-01-25

Primary Outcomes

Primary Outcomes (end points)
Psychological distress, coping skills
Primary Outcomes (explanation)
1.here will be significant reduction in psychological distress after 12 sessions of CBT based intervention among women with PCOS
2.There will be significant improvement in coping skills after 12 sessions of CBT based intervention among women with PCOS
3.There will be significant reduction in psychological distress of women with PCOS in experimental group as compared to waiting list group after 12 sessions of CBT based intervention.
4.There will be significant improvement in coping skills of women with PCOS in experimental group as compared to waiting list group after 12 sessions of CBT based intervention.

Secondary Outcomes

Secondary Outcomes (end points)
relationship insensitivity, quality of life, body image, self-esteem
Secondary Outcomes (explanation)
1. There will be a significant improvement in body image, self-esteem and the quality of life after 12 sessions of CBT based intervention among women with PCOS
2. There will be a significant reduction in interpersonal sensitivity after 12 sessions of CBT based intervention among women with PCOS
3. There will be a significant improvement in body image, self-esteem and the quality of life of women with PCOS in the experimental group as compared to waiting list group after 12 sessions of CBT based intervention.
4. There will be a significant reduction in interpersonal sensitivity of women with PCOS in the experimental group as compared to waiting list group after 12 sessions of CBT based intervention.

Experimental Design

Experimental Design
The present quantitative research will use experimental research design to verify the research hypotheses. The study will be RCT (randomized controlled trial).
Experimental Design Details
Randomization Method
simple random sampling i.e; every first member from the group will be placed in experimental group and every second member from group of 2 will be selected in waiting list group
Randomization Unit
PCOS diagnosed females
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
4 hospitals
Sample size: planned number of observations
150 females
Sample size (or number of clusters) by treatment arms
46 participants (23 in experimental group and 23 in waiting list group)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
NUMS IRB & Ethical Committee
IRB Approval Date
2024-10-23
IRB Approval Number
06/IRB&EC/NUMS/101

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials