COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain (COMPACT)

December 20, 2019 updated by: Sérgio Andrade Carvalho, University of Coimbra

COMP.ACT: Testing the Effect of Explicit Self-compassion Exercises in an ACT Group Intervention for Chronic Pain

This study tests the efficacy of adding explicit self-compassion meditation exercises in an ACT intervention for chronic pain (COMP.ACT). COMP.ACT is an 8-session, 2h each, psychological intervention for women with chronic pain. Half of participants will receive an ACT intervention + 2 Q&A sessions, and half of participants will receive an ACT intervention + 2 compassion-focused sessions with explicit self-compassion exercises.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach, with empirical support in adapting to several chronic health conditions, such as chronic pain (CP), and its main purpose is to improve functioning and decrease interference of pain with valued life goals. Although the American Psychological Association (APA) has stated ACT as having empirical support in CP (http://www.div12.org/PsychologicalTreatments/treatments/chronicpain_act.html), with several studies showing its efficacy, there is still room for improvement. This might be attained by adding theoretically compatible components such as self-compassion. Although ACT has recently incorporated self-compassion as one of its outcomes, this has not been considered in any ACT intervention study for CP. Compassion-based approaches has been effective in targeting self-criticism, and has been effective in reducing a large array of psychopathological symptoms that are also common in CP (e.g. depression and anxiety). The current study aims to test the adding value of explicit self-compassion exercises in an ACT group intervention for CP.

General study design Participants previously diagnosed with CP by a physician will be assigned into two different conditions/groups: a group intervention for CP that includes explicit self-compassion exercises (COMP.ACT); and a group intervention that does not include explicit self-compassion exercises (ACT). The efficacy of COMP.ACT will be assessed by comparing it with the ACT condition.

Sample This study aims to focus on musculoskeletal CP as it is the most common cause of CP. Also, the study will recruit women with CP. Patients will be provided a study description, a consent form and the research team contact for further clarifications.

The COMP.ACT protocol has the following goals: (a) promote engagement in meaningful and effective activities, even with pain and distress, (b) improving present-focused awareness and acceptance of thoughts, feelings, and physiological sensations; (c) developing a self-compassion stance towards personal difficulties, and (d) promote commitment and engagement with valued actions.

Study Type

Interventional

Enrollment (Anticipated)

20

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 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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • chronic pain diagnosis(es),
  • age between 18-65,
  • residence in center region of Portugal,
  • Availability to attend sessions.

Exclusion Criteria:

  • Symptoms of psychosis,
  • Non-suicidal self-injury,
  • Suicide ideation,
  • Severe Depression,
  • Substance Abuse.

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acceptance & Commitment Therapy + Compassion (COMP.ACT)
an ACT intervention + 2 sessions of explicit self-compassion meditation exercises.
Behavioral: Acceptance & Commitment Therapy + Compassion (COMP.ACT)
8 sessions, 2h each. Intervention includes meditation exercises, behavioral exercises, group discussions, and the structure is the following Session 1: INTRODUCTION: control is the problem Session 2: THE BODY AS PRESENT: promoting body awareness through mindfulness Session 3: COMPASSION I: from self-criticism to self-care Session 4: COMPASSION II: the body as an anchor to self-compassion Session 5: ACCEPTANCE: there is more to accept than just pain Session 6: (RE)DISCOVERING VALUES: in search of a valued life Session 7: ACT NOW: from values to committed action Session 8: CARRY ON AFTER COMP.ACT: program summary
ACTIVE_COMPARATOR: Acceptance & Commitment Therapy (ACT)
an ACT intervention + 2 Q&A sessions.
Behavioral: Acceptance and Commitment Therapy (ACT)
8 sessions, 2h each. Intervention includes meditation exercises, behavioral exercises, group discussions, and the structure is the following Session 1: INTRODUCTION: control is the problem Session 2: THE BODY AS PRESENT: promoting body awareness through mindfulness Session 3: Q&A 1 Session 4: Q&A 2 Session 5: ACCEPTANCE: there is more to accept than just pain Session 6: (RE)DISCOVERING VALUES: in search of a valued life Session 7: ACT NOW: from values to committed action Session 8: CARRY ON AFTER COMP.ACT: program summary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from Numeric Pain Rating Scale at 2 months (post-intervention)
Time Frame: baseline, at 2 months (post-intervention)
Pain intensity - higher scores mean more pain intensity
baseline, at 2 months (post-intervention)
change from Pain Disability Index
Time Frame: baseline, 2 months (post-intervention), 6 months (follow-up)
Pain disability - higher scores mean more pain disability
baseline, 2 months (post-intervention), 6 months (follow-up)
change from World Health Organization Quality of Life - Bref
Time Frame: baseline, 2 months (post-intervention), 6 months (follow-up)
Quality of Life - higher scores mean more quality of life
baseline, 2 months (post-intervention), 6 months (follow-up)
change from Depression Anxiety and Stress Scale - 21 items
Time Frame: baseline, 2 months (post-intervention), 6 months (follow-up)
Depression, anxiety and stress symptoms - higher scores mean more depression, anxiety and stress symptoms
baseline, 2 months (post-intervention), 6 months (follow-up)

Collaborators and Investigators

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

Sponsor

University of Coimbra

Investigators

  • Principal Investigator: Sérgio Carvalho, CINEICC - University of Coimbra

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)

January 7, 2019

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (ACTUAL)

December 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFRH/BD/112833/2015

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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