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Compassion-Focused Therapy for Chronic Pain

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ClinicalTrials.gov Identifier: NCT03471637
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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).


Condition or disease Intervention/treatment Phase
Chronic Pain Psychological Distress Other: Compassion-Focused Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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)]




Primary Outcome Measures :
  1. Strength of Self-Compassion as a mediator at Week 11 [ Time Frame: Week 1 ]
  2. Strength of Psychological Flexibility as a mediator at Week 11 [ Time Frame: Week 1 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471637


Contacts
Contact: Su Tin 0044 131 537 9128 su.tin@nhslothian.scot.nhs.uk
Contact: David Gillanders 0044 131 651 3946 david.gillanders@ed.ac.uk

Locations
United Kingdom
Astley Ainslie Hospital Recruiting
Edinburgh, Edinburgh City, United Kingdom, EH9 2HL
Contact: Su Tin, MA    0131 537 9128    su.tin@nhslothian.scot.nhs.uk   
Contact: Shona Brown, DClinPsy    0131 537 9128    shona.brown@nhslothian.scot.nhs.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Su Tin University of Edinburgh
  Study Documents (Full-Text)

Documents provided by University of Edinburgh:
Informed Consent Form  [PDF] January 25, 2018


Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03471637     History of Changes
Other Study ID Numbers: S0815692
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
Chronic Pain
Compassion-Focused Therapy
Self-Compassion
Psychological Flexibility

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms