NCT03471637

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

November 6, 2017

Last Update Submit

May 8, 2024

Conditions

Chronic PainPsychological Distress

Keywords

Chronic PainCompassion-Focused TherapySelf-CompassionPsychological Flexibility

Outcome Measures

Primary Outcomes (2)

  • Strength of Self-Compassion as a mediator at Week 11

    Week 1

  • Strength of Psychological Flexibility as a mediator at Week 11

    Week 1

Secondary Outcomes (5)

  • Self-Compassion Scale (short form, SCS-SF; Neff, 2003)

    [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: 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: 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: 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: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy]

Study Arms (1)

Compassion-Focused Therapy

EXPERIMENTAL

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

Other: Compassion-Focused Therapy

Interventions

Compassion-Focused TherapyOTHER

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

Compassion-Focused Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Astley Ainslie Hospital

Edinburgh, Edinburgh City, EH9 2HL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 17444920BACKGROUND

  • 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.

    PMID: 21377652BACKGROUND

  • 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.

    PMID: 16300724BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Su Tin

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

March 20, 2018

Study Start

February 27, 2018

Primary Completion

March 31, 2019

Study Completion

May 31, 2019

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)