- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040972
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Compassion
-
Fundación Saldarriaga ConchaPontificia Universidad Javeriana; Ministerio de Ciencia, Tecnología e InnovaciónNot yet recruitingResilience, Compassion
-
University of CoimbraFundação para a Ciência e a TecnologiaActive, not recruiting
-
Firat UniversityRecruitingSelf-Compassion TrainingTurkey
-
Hospital Israelita Albert EinsteinCompletedAttention | Self-compassionBrazil
-
University of Texas at AustinCompleted
-
Beijing Normal UniversityCompleted
-
Mackay Medical CollegeCompletedCompassion | Educational Problems | CompetenceTaiwan
-
Brigham Young UniversityTerminatedCompassion | Guilt | Self-Criticism | ShameUnited States
-
Universitat Jaume IEuropean Social Fund; Generalitat ValencianaCompletedCompassion | Mental Health Wellness 1Spain
-
Boston University Charles River CampusCompleted
Clinical Trials on Compassion Focussed Therapy
-
Charite University, Berlin, GermanySana-Klinikum Lichtenberg; Vivantes Klinikum am Urban; Park-Klinik Berlin Weißensee and other collaboratorsRecruiting
-
University of SevilleNot yet recruiting
-
National University of Ireland, Galway, IrelandUnknown
-
Institute of Psychiatry, LondonSouth London and Maudsley NHS Foundation TrustRecruitingBipolar Affective DisorderUnited Kingdom
-
King's College LondonCompleted
-
University of EdinburghNHS LothianUnknown
-
King's College LondonNot yet recruitingAcquired Brain Injury Including Stroke
-
NHS Greater Glasgow and ClydeUniversity of GlasgowTerminatedDepression | Anxiety DisordersUnited Kingdom
-
Christal L BadourRecruitingStress Disorders, Post-Traumatic | Guilt | Shame | Sexual Assault and RapeUnited States