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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359639
Other study ID # USM/JEPeM/KK/23080645
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date September 2024

Study information

Verified date April 2024
Source Universiti Sains Malaysia
Contact Michelle Choong
Phone +60169150941
Email breakupresearch.usm@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Michelle Choong Poh Kin

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Primary 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. 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.
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