Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

NCT04040972 | Completed

• 1 other identifier: 18/SS/0164
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Adjustment; Compassion; Chronic Disease

Outcome Measures

Primary Outcomes (5)

• 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.

• 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

• 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

• 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

• 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 Outcomes (1)

• 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.

Study Arms (1)

Rebalance - Group Compassion Focussed Therapy

EXPERIMENTAL

Other: Compassion Focussed Therapy

Interventions

Compassion Focussed Therapy OTHER

Group compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time.

Rebalance - Group Compassion Focussed Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

NHS Lothian Clinical Health Psychology Service

Edinburgh, EH9 2HL, United Kingdom

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 1, 2019
• Study Start: July 4, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)