Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

November 7, 2022 updated by: University of Edinburgh

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

6

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 Locations

      • Edinburgh, United Kingdom, EH9 2HL
        • NHS Lothian Clinical Health Psychology Service

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rebalance - Group Compassion Focussed Therapy
Group compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily diary questions (assessing change over time)
Time Frame: Daily throughout baseline (14-5 days) and intervention (10 weeks). May also be collected for 7 days at time of three month follow up.
3 questions relating to the participants sense of adjustment and self-compassion on that day. Each question uses a five-point likert scale from 1 (very poorly) to 5 (very well)
Daily throughout baseline (14-5 days) and intervention (10 weeks). May also be collected for 7 days at time of three month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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 (Actual)

July 4, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 18/SS/0164

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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