Chronic PainNCT03471637
Compassion-Focused Therapy for Chronic Pain
A study testing Compassion-Focused Therapy in people with Chronic Pain and Psychological Distress, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This research aims to study how Compassion-Focused Therapy (CFT) might work for people with chronic pain. People with chronic pain may feel shameful about their condition and this type of therapy aims to help people to view themselves and their difficulties in a kinder, less critical way (i.e. self-compassion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Psychological Distress
- What is being tested?
- Compassion-Focused Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2018to 31 May 2019
- 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
- Fluency of English sufficient for participation in the group and completion of questionnaires
- Aged 18+ (no upper age limit)
- Ability to provide informed consent (as defined by the Five Statutory Principles of the Mental Capacity Act, Code of Practice, 2007)
Who cannot join
- Active substance misuse
- Active suicidality
- Terminal illness
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Astley Ainslie Hospital
Edinburgh, Edinburgh City, EH9 2HL
About this study
Official title: How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?
This research aims to study how Compassion-Focused Therapy (CFT) might work for people with chronic pain. People with chronic pain may feel shameful about their condition and this type of therapy aims to help people to view themselves and their difficulties in a kinder, less critical way (i.e. self-compassion). Currently, no research is available on the effectiveness of CFT in helping people with chronic pain.
Participants attending a CFT-incorporated Pain Management Programme will complete a battery of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and at the end of the group (week 11).
Read the detailed description
Pain Management Programmes help people to manage their pain and improve quality of life, and this research will look into the processes by which this happens. This study will look at two psychological concepts: 'self-compassion' (kindness to self) and 'psychological flexibility' (willingness to tolerate difficult experiences in order to meet meaningful goals). These concepts help in understanding how people think about themselves in the context of pain.
Principle Research Question: Do self-compassion and psychological flexibility mediate change (anxiety/depression/well-being) in a Compassion-Focused Therapy group for adults with chronic pain?
Primary Outcome Measure: Strength of mediation effects
Sample Size:
[Reference 1] propose guidelines for recommended sample sizes in order to detect mediation effects with .8 power. These guidelines are informed by existing literature in the field. There is less robust research on self-compassion and chronic pain, therefore, this calculation is based on research in psychological flexibility and chronic pain.
[Reference 2] conducted correlational analyses on the processes of psychological flexibility following a group intervention based on ACT. These processes included acceptance of pain, mindfulness, psychological acceptance and values-based action (r values between 0.33 and 0.55). These positive correlations indicate that the group intervention was related to higher levels of psychological flexibility.
[Reference 3]'s review identified several studies that reported correlational effect sizes between acceptance, and depression/anxiety/daily functioning related to chronic pain (r = -0.58/-0.66/0.47 respectively). These negative correlations illustrate that higher levels of psychological flexibility were related to better outcomes.
Based on these correlational effect sizes, guidelines in [Reference 1] suggest that a sample size of 53-71 is required.
Analysis:
The analysis will focus on the proposed mediating factors (self-compassion and psychological flexibility) and how they explain the outcome of the CFT-incorporated group intervention. In order to study the processes of change, this study will measure change in mediators and outcomes over the course of the group.
In a mediation model, the effect of the independent variable (IV; CFT group) on a dependent variable (DV; outcome/change in symptoms) is conveyed through a third mediating variable. In order to be a mediator, a variable must change during the intervention, be associated with the intervention, and have an impact on the outcome.
In this study, it is hypothesised that self-compassion and/or psychological flexibility are the mediating variables that explain the influence of the group intervention on eventual outcome, i.e. the overall change in symptoms at the end of the group. Linear regression and nonparametric bias-corrected bootstrap, which corrects for skew in the data, will be applied to the data using SPSS, using the PROCESS macro. An effect of mediation will be indicated if the confidence interval does not contain zero.
Missing data will be handled using either the maximum likelihood or multiple imputation method, as recommended in literature.
- Conditions
- Chronic Pain, Psychological Distress
- Being tested
- Compassion-Focused Therapy
- Keywords
- Chronic Pain, Compassion-Focused Therapy, Self-Compassion, Psychological Flexibility
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Focused TherapyOther
Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]
| Study group | Role | What they receive |
|---|---|---|
| Compassion-Focused Therapy | Experimental | Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)] Receives: Other: Compassion-Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of Self-Compassion as a mediator at Week 11
Measured: Week 1
Strength of Psychological Flexibility as a mediator at Week 11
Measured: Week 1
Secondary outcomes (5)
Self-Compassion Scale (short form, SCS-SF; Neff, 2003)
Minimum score: 12; maximum score: 60; higher score indicates higher level of self-compassion
Measured: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Multi-Dimensional Psychological Flexibility Inventory (short form, MPFI-SF; Rolffs et al., 2016)
Minimum score: 24; maximum score 144; higher score indicates higher level of psychological flexibility
Measured: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Brief Pain Inventory (short form, BPI-SF; Cleeland & Ryan, 1994)
Minimum score: 0; maximum score 110; higher score indicates greater level of pain severity and pain interference (severity max 40 / interference max 70)
Measured: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (Tennant et al., 2007)
Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
Measured: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)
Minimum score: 0; maximum score: 42; higher score indicates higher level of anxiety and depression (anxiety max 21 / depression max 21)
Measured: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start27 Feb 2018
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Su Tin, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471637
- Sponsor's protocol ID
- S0815692
- Status last verified
- May 2024
- First submitted
- 6 Nov 2017
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fritz MS, Mackinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007 Mar;18(3):233-9. doi: 10.1111/j.1467-9280.2007.01882.x.
PubMed 17444920McCracken LM, Gutierrez-Martinez O. Processes of change in psychological flexibility in an interdisciplinary group-based treatment for chronic pain based on Acceptance and Commitment Therapy. Behav Res Ther. 2011 Apr;49(4):267-74. doi: 10.1016/j.brat.2011.02.004. Epub 2011 Feb 15.
PubMed 21377652Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
PubMed 16300724
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?
- ClinicalTrials.gov ID
- NCT03471637
- Acronym / sponsor ID
- S0815692
- Conditions
- Chronic Pain, Psychological Distress
- Keywords
- Chronic Pain, Compassion-Focused Therapy, Self-Compassion, Psychological Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 20 Mar 2018 (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 research aims to study how Compassion-Focused Therapy (CFT) might work for people with chronic pain. People with chronic pain may feel shameful about their condition and this type of therapy aims to help people to view themselves and their difficulties in a kinder, less critical way (i.e. self-compassion). Currently, no research is available on the effectiveness of CFT in helping people with chronic pain.
Participants attending a CFT-incorporated Pain Management Programme will complete a battery of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and at the end of the group (week 11).
Detailed description
Pain Management Programmes help people to manage their pain and improve quality of life, and this research will look into the processes by which this happens. This study will look at two psychological concepts: 'self-compassion' (kindness to self) and 'psychological flexibility' (willingness to tolerate difficult experiences in order to meet meaningful goals). These concepts help in understanding how people think about themselves in the context of pain.
Principle Research Question: Do self-compassion and psychological flexibility mediate change (anxiety/depression/well-being) in a Compassion-Focused Therapy group for adults with chronic pain?
Primary Outcome Measure: Strength of mediation effects
Sample Size:
[Reference 1] propose guidelines for recommended sample sizes in order to detect mediation effects with .8 power. These guidelines are informed by existing literature in the field. There is less robust research on self-compassion and chronic pain, therefore, this calculation is based on research in psychological flexibility and chronic pain.
[Reference 2] conducted correlational analyses on the processes of psychological flexibility following a group intervention based on ACT. These processes included acceptance of pain, mindfulness, psychological acceptance and values-based action (r values between 0.33 and 0.55). These positive correlations indicate that the group intervention was related to higher levels of psychological flexibility.
[Reference 3]'s review identified several studies that reported correlational effect sizes between acceptance, and depression/anxiety/daily functioning related to chronic pain (r = -0.58/-0.66/0.47 respectively). These negative correlations illustrate that higher levels of psychological flexibility were related to better outcomes.
Based on these correlational effect sizes, guidelines in [Reference 1] suggest that a sample size of 53-71 is required.
Analysis:
The analysis will focus on the proposed mediating factors (self-compassion and psychological flexibility) and how they explain the outcome of the CFT-incorporated group intervention. In order to study the processes of change, this study will measure change in mediators and outcomes over the course of the group.
In a mediation model, the effect of the independent variable (IV; CFT group) on a dependent variable (DV; outcome/change in symptoms) is conveyed through a third mediating variable. In order to be a mediator, a variable must change during the intervention, be associated with the intervention, and have an impact on the outcome.
In this study, it is hypothesised that self-compassion and/or psychological flexibility are the mediating variables that explain the influence of the group intervention on eventual outcome, i.e. the overall change in symptoms at the end of the group. Linear regression and nonparametric bias-corrected bootstrap, which corrects for skew in the data, will be applied to the data using SPSS, using the PROCESS macro. An effect of mediation will be indicated if the confidence interval does not contain zero.
Missing data will be handled using either the maximum likelihood or multiple imputation method, as recommended in literature.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion-Focused Therapy | Experimental | Other: Compassion-Focused TherapyCompassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluency of English sufficient for participation in the group and completion of questionnaires
- Aged 18+ (no upper age limit)
- Ability to provide informed consent (as defined by the Five Statutory Principles of the Mental Capacity Act, Code of Practice, 2007)
Key exclusion criteria (4 listed)
- Active substance misuse
- Active suicidality
- Terminal illness
- Inability to provide informed consent
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-Focused TherapyCompassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)] | Other | Compassion-Focused Therapy |
Primary outcome
Strength of Self-Compassion as a mediator at Week 11
Time frame: Week 1
Strength of Psychological Flexibility as a mediator at Week 11
Time frame: Week 1
5 secondary outcomes
Self-Compassion Scale (short form, SCS-SF; Neff, 2003)
Time frame: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Multi-Dimensional Psychological Flexibility Inventory (short form, MPFI-SF; Rolffs et al., 2016)
Time frame: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Brief Pain Inventory (short form, BPI-SF; Cleeland & Ryan, 1994)
Time frame: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (Tennant et al., 2007)
Time frame: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)
Time frame: [Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
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 9 May 2024.
- Background: PubMed 17444920Fritz MS, Mackinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007 Mar;18(3):233-9. doi: 10.1111/j.1467-9280.2007.01882.x.
- Background: PubMed 21377652McCracken LM, Gutierrez-Martinez O. Processes of change in psychological flexibility in an interdisciplinary group-based treatment for chronic pain based on Acceptance and Commitment Therapy. Behav Res Ther. 2011 Apr;49(4):267-74. doi: 10.1016/j.brat.2011.02.004. Epub 2011 Feb 15.
- Background: PubMed 16300724Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- 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.
Su Tin principal investigator
University of Edinburgh
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-Focused Therapy in people with Chronic Pain and Psychological Distress, 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 3 inclusion and 4 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 9 May 2024. 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?
Strength of Self-Compassion as a mediator at Week 11 (time frame: Week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471637, which also lists 3 linked publications.
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 9 May 2024.