- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359639
Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults
April 5, 2024 updated by: Michelle Choong Poh Kin
Randomised Controlled Trial of Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth
The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults.
Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts.
The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling?
Participants will receive five online sessions of either cognitive restructuring or counselling.
Data on participants' breakup distress and personal growth will be collected before and after completion of sessions.
The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michelle Choong
- Phone Number: +60169150941
- Email: breakupresearch.usm@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Malaysian young adults.
- Proficient in English.
- Basic technological skill and resources.
- Reported ongoing distress due to a breakup that occurred within the past 6 months.
- Current single relationship status.
Exclusion Criteria:
- Consumption of psychiatric medications within past 8 weeks.
- Currently receiving other psychological interventions.
- Presence of significant psychotic or manic symptoms.
- Severe suicide risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive restructuring
|
Five 50-60-minute videoconferencing sessions of cognitive restructuring based on Mind Over Mood: Second Edition (MOM2) (Greenberger & Padesky, 2016) and The Clinician's Guide to CBT Using MOM2 (Padesky & Greenberger, 2019) as guides.
The sessions will consist of understanding the cognitive model, filling in Thought Records, and complementary coping strategies of looking for evidence, action planning, and acceptance.
|
|
Active Comparator: Supportive counselling
|
Five 50-60-minute videoconferencing sessions of supportive counselling consisting of psychoeducation on breakup effects, validation of breakup experiences and emotions, introduction to deep breathing and progressive muscle relaxation, and identification of existing coping strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breakup distress
Time Frame: BDS will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
|
Breakup Distress Scale (BDS) (Field et al., 2009) will be used to assess breakup distress.
The total score ranges from 16 to 64 with higher scores indicating higher breakup distress.
|
BDS will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
|
|
Posttraumatic growth
Time Frame: PTGI will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
|
Posttraumatic Growth Inventory (PTGI) (Tedeschi & Calhoun, 1996) will be used to assess personal growth after breakup.
The total score ranges from 0 to 105 with higher scores indicating higher posttraumatic growth.
|
PTGI will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
March 9, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- USM/JEPeM/KK/23080645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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