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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Acceptance & Commitment Therapy + Compassion (COMP.ACT)
Acceptance and Commitment Therapy (ACT)
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, Acceptance and Commitment Therapy (ACT), Compassion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Consulta da dor, Serviço de AnestesiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance & Commitment Therapy + Compassion (COMP.ACT)

Acceptance & Commitment Therapy (ACT)

Arm Description

an ACT intervention + 2 sessions of explicit self-compassion meditation exercises.

an ACT intervention + 2 Q&A sessions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2019
Last Updated
December 20, 2019
Sponsor
University of Coimbra
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1. Study Identification

Unique Protocol Identification Number
NCT04210466
Brief Title
COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain
Acronym
COMPACT
Official Title
COMP.ACT: Testing the Effect of Explicit Self-compassion Exercises in an ACT Group Intervention for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, Acceptance and Commitment Therapy (ACT), Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance & Commitment Therapy + Compassion (COMP.ACT)
Arm Type
Experimental
Arm Description
an ACT intervention + 2 sessions of explicit self-compassion meditation exercises.
Arm Title
Acceptance & Commitment Therapy (ACT)
Arm Type
Active Comparator
Arm Description
an ACT intervention + 2 Q&A sessions.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance & Commitment Therapy + Compassion (COMP.ACT)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
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
Primary Outcome Measure Information:
Title
change from Numeric Pain Rating Scale at 2 months (post-intervention)
Description
Pain intensity - higher scores mean more pain intensity
Time Frame
baseline, at 2 months (post-intervention)
Title
change from Pain Disability Index
Description
Pain disability - higher scores mean more pain disability
Time Frame
baseline, 2 months (post-intervention), 6 months (follow-up)
Title
change from World Health Organization Quality of Life - Bref
Description
Quality of Life - higher scores mean more quality of life
Time Frame
baseline, 2 months (post-intervention), 6 months (follow-up)
Title
change from Depression Anxiety and Stress Scale - 21 items
Description
Depression, anxiety and stress symptoms - higher scores mean more depression, anxiety and stress symptoms
Time Frame
baseline, 2 months (post-intervention), 6 months (follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Carvalho
Phone
916365827
Email
sergiocarvalho@fpce.uc.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sérgio Carvalho
Organizational Affiliation
CINEICC - University of Coimbra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consulta da dor, Serviço de Anestesiologia
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Lapa, PhD
Email
teresalapa@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain

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