Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

Sponsor

University of Edinburgh (Other)

Overall Status

Unknown status

CT.gov ID

NCT04040972

Collaborator

NHS Lothian (Other)

Enrollment

Location

Arm

12.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Adjustment Compassion Chronic Disease	Other: Compassion Focussed Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 4, 2019

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rebalance - Group Compassion Focussed Therapy	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.

Arm

Intervention/Treatment

Experimental: Rebalance - Group Compassion Focussed Therapy

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.

Outcome Measures

Primary Outcome Measures

The compassionate engagement and action scales (assessing change over time) [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) [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) [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) [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)
The Warwick-Edinburgh Mental Well-being scale (assessing change over time) [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).

Secondary Outcome Measures

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.]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHS Lothian Clinical Health Psychology Service	Edinburgh		United Kingdom	EH9 2HL

Sponsors and Collaborators

University of Edinburgh
NHS Lothian

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Edinburgh

ClinicalTrials.gov Identifier:

NCT04040972

Other Study ID Numbers:

18/SS/0164

First Posted:

Aug 1, 2019

Last Update Posted:

Aug 1, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Disease

Study Results

No Results Posted as of Aug 1, 2019