NCT06359639

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

March 9, 2024

Last Update Submit

April 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Cognitive restructuring

EXPERIMENTAL
Behavioral: Cognitive restructuring

Supportive counselling

ACTIVE COMPARATOR
Behavioral: Supportive counselling

Interventions

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.

Cognitive restructuring

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.

Supportive counselling

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Consumption of psychiatric medications within past 8 weeks.
  • Currently receiving other psychological interventions.
  • Presence of significant psychotic or manic symptoms.
  • Severe suicide risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cognitive Restructuring

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Clinical Psychology candidate

Study Record Dates

First Submitted

March 9, 2024

First Posted

April 11, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share