Breakup DistressNCT06359639
Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults
A study testing Cognitive restructuring and Supportive counselling in people with Breakup Distress and Posttraumatic Growth, run by Michelle Choong Poh Kin.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Breakup Distress, Posttraumatic Growth
- What is being tested?
- Cognitive restructuring and Supportive counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Consumption of psychiatric medications within past 8 weeks.
- Currently receiving other psychological interventions.
- Presence of significant psychotic or manic symptoms.
- Severe suicide risk.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Breakup Distress, Posttraumatic Growth
- Being tested
- Cognitive restructuring, Supportive counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive restructuringBehavioural
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.
Supportive counsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive restructuring | Experimental | Not described Receives: Behavioral: Cognitive restructuring |
| Supportive counselling | Active comparator | Not described Receives: Behavioral: Supportive counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breakup distress
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakup DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Choong Poh Kin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle Choong Poh Kin, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359639
- Sponsor's protocol ID
- USM/JEPeM/KK/23080645
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth
- ClinicalTrials.gov ID
- NCT06359639
- Acronym / sponsor ID
- USM/JEPeM/KK/23080645
- Conditions
- Breakup Distress, Posttraumatic Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Michelle Choong Poh KinUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive restructuring | Experimental | Behavioral: Cognitive restructuring |
| Supportive counselling | Active comparator | Behavioral: Supportive counselling |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Consumption of psychiatric medications within past 8 weeks.
- Currently receiving other psychological interventions.
- Presence of significant psychotic or manic symptoms.
- Severe suicide risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive restructuringFive 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. | Behavioural | Cognitive restructuring |
| Supportive counsellingFive 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. | Behavioural | Supportive counselling |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Breakup Distress
Recruiting
Psychodrama Group Therapy for Breakup Distress and Relationship Adjustment: A Randomized Trial
Breakup Distress, Dyadic Adjustment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive restructuring and Supportive counselling in people with Breakup Distress and Posttraumatic Growth, run by Michelle Choong Poh Kin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Choong (+60169150941, breakupresearch.usm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.