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

Last registered on April 30, 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
April 30, 2025, 1:45 AM EDT

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
Completed
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 a prevalent endocrine disorder, affecting approximately 8–13% of women of reproductive age. Beyond its physiological implications, PCOS significantly influences emotional and psychological functioning, often manifesting in concerns related to body image, diminished self-esteem, and psychological distress tied to physical symptoms (Azizi & Elyasi, 2017; Dewani et al., 2023). Coping strategies play a pivotal role in navigating these challenges. Adaptive coping mechanisms, such as problem-focused strategies, have been shown to alleviate stress and enhance overall quality of life (Morshedi et al., 2021). Conversely, maladaptive responses like avoidance or escape strategies are associated with heightened distress, interpersonal difficulties, and increased sensitivity (Ding et al., 2021). Despite advancements in medical treatments for endocrine disorders, limited attention has been given to the psychological implications and management of PCOS. To bridge this gap, the present study aims to explore the impact of a CBT-based intervention in addressing psychological difficulties associated with PCOS.

Objectives: The primary aim is to reduce psychological distress and strengthen coping strategies in women with PCOS. Secondary objectives include improvements in body image, self-esteem, interpersonal sensitivity, and PCOS-related quality of life.

Research Design: A randomized controlled trial will be conducted involving 46 women aged 20–39 diagnosed with PCOS. Participants will be randomly assigned to either an experimental group (n = 23) or a waitlist control group (n = 23). The study will include three phases: pretest, intervention, and post-test. All participants will complete pre- and post-intervention assessments. However, only the experimental group will receive a 6-week CBT-based intervention, consisting of 12 structured sessions. Assessment tools will include the Depression Anxiety Stress Scale-21 (Lovibond & Lovibond, 1995), Brief COPE (Carver, 1997), Body Self-Image Questionnaire-Short Form (Rowe, 2005), Rosenberg Self-Esteem Scale (Rosenberg, 1997), Interpersonal Sensitivity Measure (Boyce & Parker, 1989), and the PCOS Quality of Life Scale (Williams et al., 2018).

Statistical Analysis: Data will be analyzed using IBM SPSS version 26. Paired and independent sample t-tests will be conducted to evaluate the effectiveness of the intervention on both primary and secondary outcomes.

Anticipated Results & Significance: The intervention is anticipated to yield significant reductions in psychological distress and improvements in coping abilities. Furthermore, favorable outcomes are expected in terms of body image, self-esteem, interpersonal sensitivity, and overall quality of life. Findings from this study will offer valuable evidence for the integration of CBT into comprehensive treatment plans for women with PCOS, addressing both psychological and physiological dimensions of the condition.
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. April 30. https://doi.org/10.1257/rct.14402-2.2
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)

Secondary Outcomes

Secondary Outcomes (end points)
relationship insensitivity, quality of life, body image, self-esteem
Secondary Outcomes (explanation)

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