Back to resultsRebalance: Compassion Focused Therapy in a Transdiagnostic Health Group
Primary Purpose
Psychological Adjustment, Compassion, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compassion Focussed Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Adjustment
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
Sites / Locations
- NHS Lothian Clinical Health Psychology Service
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rebalance - Group Compassion Focussed Therapy
Arm Description
Outcomes
Primary Outcome Measures
The compassionate engagement and action scales (assessing change over time)
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)
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)
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)
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)
The Warwick-Edinburgh Mental Well-being scale (assessing change over time)
A 14 item measure of psychological wellbeing scored 1 (none of the time) to 5 (all of the time).
Secondary Outcome Measures
Daily diary questions (assessing change over time)
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)
Full Information
NCT ID
NCT04040972
First Posted
July 23, 2019
Last Updated
November 7, 2022
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT04040972
Brief Title
Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group
Official Title
Rebalance: Group Compassion Focussed Therapy for People With Transdiagnostic Chronic Health Conditions - a Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Adjustment, Compassion, Chronic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebalance - Group Compassion Focussed Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Compassion Focussed Therapy
Intervention Description
Group compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time.
Primary Outcome Measure Information:
Title
The compassionate engagement and action scales (assessing change over time)
Description
Measure of compassion compromising three subscales. Each scale contains two sub-sections. All answers on scale of 1 (Never) to 10 (Always).
Time Frame
Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up.
Title
Work and social adjustment scale (assessing change over time)
Description
A 5-item measure of functional impairment due to a specified stressor. Each question is scored 1 (Not at all) to 8 (very severely)
Time Frame
Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Title
Self-efficacy for managing chronic disease scale (assessing change over time)
Description
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).
Time Frame
Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Title
Illness Cognition Questionnaire (assessing change over time)
Description
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)
Time Frame
Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Title
The Warwick-Edinburgh Mental Well-being scale (assessing change over time)
Description
A 14 item measure of psychological wellbeing scored 1 (none of the time) to 5 (all of the time).
Time Frame
Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Secondary Outcome Measure Information:
Title
Daily diary questions (assessing change over time)
Description
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)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
NHS Lothian Clinical Health Psychology Service
City
Edinburgh
ZIP/Postal Code
EH9 2HL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group
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