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Compassion-Focused Therapy for Chronic Pain

Primary Purpose

Chronic Pain, Psychological Distress

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compassion-Focused Therapy
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Chronic Pain, Compassion-Focused Therapy, Self-Compassion, Psychological Flexibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Astley Ainslie HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compassion-Focused Therapy

Arm Description

Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]

Outcomes

Primary Outcome Measures

Strength of Self-Compassion as a mediator at Week 11
Strength of Psychological Flexibility as a mediator at Week 11

Secondary Outcome Measures

Self-Compassion Scale (short form, SCS-SF; Neff, 2003)
Minimum score: 12; maximum score: 60; higher score indicates higher level of self-compassion
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
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)
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
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)

Full Information

First Posted
November 6, 2017
Last Updated
April 30, 2018
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT03471637
Brief Title
Compassion-Focused Therapy for Chronic Pain
Official Title
How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Psychological Distress
Keywords
Chronic Pain, Compassion-Focused Therapy, Self-Compassion, Psychological Flexibility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compassion-Focused Therapy
Arm Type
Experimental
Arm Description
Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]
Intervention Type
Other
Intervention Name(s)
Compassion-Focused Therapy
Intervention Description
Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on "Compassion-Focused Therapy for Dummies" (Welford, 2016)]
Primary Outcome Measure Information:
Title
Strength of Self-Compassion as a mediator at Week 11
Time Frame
Week 1
Title
Strength of Psychological Flexibility as a mediator at Week 11
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Self-Compassion Scale (short form, SCS-SF; Neff, 2003)
Description
Minimum score: 12; maximum score: 60; higher score indicates higher level of self-compassion
Time Frame
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Title
Multi-Dimensional Psychological Flexibility Inventory (short form, MPFI-SF; Rolffs et al., 2016)
Description
Minimum score: 24; maximum score 144; higher score indicates higher level of psychological flexibility
Time Frame
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Title
The Brief Pain Inventory (short form, BPI-SF; Cleeland & Ryan, 1994)
Description
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
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Title
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (Tennant et al., 2007)
Description
Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing
Time Frame
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]
Title
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)
Description
Minimum score: 0; maximum score: 42; higher score indicates higher level of anxiety and depression (anxiety max 21 / depression max 21)
Time Frame
[Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su Tin
Phone
0044 131 537 9128
Email
su.tin@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
David Gillanders
Phone
0044 131 651 3946
Email
david.gillanders@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Tin
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Astley Ainslie Hospital
City
Edinburgh
State/Province
Edinburgh City
ZIP/Postal Code
EH9 2HL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Tin, MA
Phone
0131 537 9128
Email
su.tin@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Shona Brown, DClinPsy
Phone
0131 537 9128
Email
shona.brown@nhslothian.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17444920
Citation
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.
Results Reference
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PubMed Identifier
21377652
Citation
McCracken 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.
Results Reference
background
PubMed Identifier
16300724
Citation
Hayes 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.
Results Reference
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Compassion-Focused Therapy for Chronic Pain

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