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

Last registered on May 02, 2025
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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
May 02, 2025, 1:28 AM EDT

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

Locations

Country
Pakistan
Region
Rawalpindi/Islamabad

Primary Investigator

Name
Kishwar Altaf
Affiliation
National University of Medical Sciences
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Muhammad Rizwan
PI Affiliation
National University of Medical Sciences
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2024-08-19
End date
2025-01-25
Keywords
Behavior
Additional Keywords
CBT for PCOS
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Polycystic Ovarian Syndrome (PCOS) is a common hormonal disorder among women of reproductive age that extends beyond physical symptoms to affect mental and emotional health. Women with PCOS often experience challenges such as low self-worth, dissatisfaction with body image, and elevated emotional distress. Coping strategies play a critical role in managing these difficulties, with adaptive approaches linked to better psychological outcomes. This study investigates the effectiveness of a cognitive behavioral therapy (CBT)-based intervention in reducing psychological distress and enhancing coping strategies in women diagnosed with PCOS. A randomized controlled design will be employed with 46 participants, divided equally into intervention and waitlist control groups. The CBT program will span six weeks and consist of twelve structured sessions. Standardized tools will be used to assess emotional distress, coping patterns, body image perception, self-esteem, interpersonal sensitivity, and quality of life before and after the intervention. It is expected that the intervention group will show notable improvements across all measured domains. The results aim to highlight the relevance of incorporating psychological interventions like CBT into the holistic management 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. May 02. https://doi.org/10.1257/rct.14402-2.3
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Participants assigned to the experimental group will take part in a six-week individual cognitive behavioral therapy (CBT) program, drawing upon Beck’s framework (1979). The intervention comprises 12 structured sessions, held twice weekly, each lasting approximately 45 minutes. The primary aim is to reduce emotional distress and enhance adaptive coping, while also promoting improvements in body image, self-worth, interpersonal sensitivity, and quality of life specific to PCOS. Sessions will include psychoeducation, techniques to manage symptoms of depression, anxiety, and stress, and the development of healthier coping strategies. A structured intervention protocol will guide the sessions, and participants will be supported with printed materials, including worksheets and informational handouts to reinforce session content.
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)
Supporting Documents and Materials
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
Analysis Plan

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