Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040972
• Other study ID #: 18/SS/0164
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: November 2022
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Compassion
• Psychological Adjustment

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	NHS Lothian Clinical Health Psychology Service	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up.
Primary	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)	Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Primary	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).	Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Primary	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)	Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Primary	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).	Recorded weekly throughout baseline period and ten week intervention. Also collected once at 3 month follow up
Secondary	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)	Daily throughout baseline (14-5 days) and intervention (10 weeks). May also be collected for 7 days at time of three month follow up.