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Clinical Trials/NCT04040972
NCT04040972
Completed
Not Applicable

Rebalance: Group Compassion Focussed Therapy for People With Transdiagnostic Chronic Health Conditions - a Case Series

University of Edinburgh1 site in 1 country6 target enrollmentJuly 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Adjustment
Sponsor
University of Edinburgh
Enrollment
6
Locations
1
Primary Endpoint
The Warwick-Edinburgh Mental Well-being scale (assessing change over time)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study evaluates the use of group Compassion Focussed Therapy in a population with various and/or multiple long term health conditions. A multiple baseline, single case experimental design will be used with a view to evaluate changes in psychological adjustment and compassion. Daily data and weekly questionnaire batteries will be collected across a baseline period and ten weeks of group intervention. Participants will be those already referred to the group by a clinician as part of their routine care.

Registry
clinicaltrials.gov
Start Date
July 4, 2019
End Date
May 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Experiencing difficulties adjusting to one or more chronic physical health condition(s)
  • Willing and motivated to attend a nine-week group facilitated in English
  • Exhibit sufficient interpersonal skills and impulse control to allow them to engage with group members without disrupting group dynamics
  • Able to provide informed consent

Exclusion Criteria

  • Moderate or severe impairment of cognitive function
  • Primary problem related to drug or alcohol misuse
  • Actively suicidal or experiencing an acute deterioration in their mental health including experiencing an acute psychotic episode

Outcomes

Primary Outcomes

The Warwick-Edinburgh Mental Well-being scale (assessing change over time)

Time Frame: Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up

A 14 item measure of psychological wellbeing scored 1 (none of the time) to 5 (all of the time).

The compassionate engagement and action scales (assessing change over time)

Time Frame: Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up.

Measure of compassion compromising three subscales. Each scale contains two sub-sections. All answers on scale of 1 (Never) to 10 (Always).

Work and social adjustment scale (assessing change over time)

Time Frame: Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up

A 5-item measure of functional impairment due to a specified stressor. Each question is scored 1 (Not at all) to 8 (very severely)

Self-efficacy for managing chronic disease scale (assessing change over time)

Time Frame: Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up

A 6-item measure of perceived self-efficacy to adherence to recommended self-management programs. Each item scored 1 (not at all confident) to 10 (totally confident).

Illness Cognition Questionnaire (assessing change over time)

Time Frame: Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up

18 items each rated on a four-point scale with high internal validity (all above 0.81. Assessing three domains of perceiving illness (helplessness, acceptance and perceived benefits) this tool identifies maladaptive cognitive styles surrounding illness which are linked to poorer psychological outcomes. Scored 1 (not at all) to 4 (completely)

Secondary Outcomes

  • Daily diary questions (assessing change over time)(Daily throughout baseline (14-5 days) and intervention (10 weeks). May also be collected for 7 days at time of three month follow up.)

Study Sites (1)

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