Compassion-Focused Therapy for Chronic Pain

April 30, 2018 updated by: University of Edinburgh

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Please note this study is only recruiting people who have been referred and accepted onto NHS Lothian's Pain Management Programme (part of the Lothian Pain Service at the Astley Ainslie Hospital).

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Active substance misuse
  • Active suicidality
  • Terminal illness
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compassion-Focused Therapy
Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]
Other: Compassion-Focused Therapy
Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Strength of Self-Compassion as a mediator at Week 11
Time Frame: Week 1
Week 1
Strength of Psychological Flexibility as a mediator at Week 11
Time Frame: Week 1
Week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Minimum score: 12; maximum score: 60; higher score indicates higher level of self-compassion
[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]
Minimum score: 24; maximum score 144; higher score indicates higher level of psychological flexibility
[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]
Minimum score: 0; maximum score 110; higher score indicates greater level of pain severity and pain interference (severity max 40 / interference max 70)
[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]
Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
[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]
Minimum score: 0; maximum score: 42; higher score indicates higher level of anxiety and depression (anxiety max 21 / depression max 21)
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Su Tin, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S0815692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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