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Completed

NCT Number: NCT04040972

Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

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.

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Key information

Conditions

Psychological Adjustment Chronic Disease Compassion Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian Clinical Health Psychology Service

Edinburgh, EH9 2HL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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)

  3. 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).

  4. 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)

  5. 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).

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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