Psychological AdjustmentNCT04040972
Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group
A study testing Compassion Focussed Therapy in people with Psychological Adjustment and Compassion, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Adjustment, Compassion, Chronic Disease
- What is being tested?
- Compassion Focussed Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Lothian Clinical Health Psychology Service
Edinburgh, EH9 2HL
About this study
Official title: Rebalance: Group Compassion Focussed Therapy for People With Transdiagnostic Chronic Health Conditions - a Case Series
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
- Being tested
- Compassion Focussed Therapy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Focussed TherapyOther
Group compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time.
| Study group | Role | What they receive |
|---|---|---|
| Rebalance - Group Compassion Focussed Therapy | Experimental | Not described Receives: Other: Compassion Focussed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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)
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)
Measured: Daily throughout baseline (14-5 days) and intervention (10 weeks). May also be collected for 7 days at time of three month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start4 Jul 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological AdjustmentStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040972
- Sponsor's protocol ID
- 18/SS/0164
- Status last verified
- Nov 2022
- First submitted
- 23 Jul 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebalance: Group Compassion Focussed Therapy for People With Transdiagnostic Chronic Health Conditions - a Case Series
- ClinicalTrials.gov ID
- NCT04040972
- Acronym / sponsor ID
- 18/SS/0164
- Conditions
- Psychological Adjustment, Compassion, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebalance - Group Compassion Focussed Therapy | Experimental | Other: Compassion Focussed Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Focussed TherapyGroup compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time. | Other | Rebalance - Group Compassion Focussed Therapy |
Primary outcome
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).
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)
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).
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)
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Focussed Therapy in people with Psychological Adjustment and Compassion, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.