Clinical trial NCT04210466: COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain
Official title: COMP.ACT: Testing the Effect of Explicit Self-compassion Exercises in an ACT Group Intervention for Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
Acceptance and Commitment Therapy (ACT)
Compassion
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change from Numeric Pain Rating Scale at 2 months (post-intervention)
timeFrame: baseline, at 2 months (post-intervention)
measure: change from Pain Disability Index
timeFrame: baseline, 2 months (post-intervention), 6 months (follow-up)
measure: change from World Health Organization Quality of Life - Bref
timeFrame: baseline, 2 months (post-intervention), 6 months (follow-up)
measure: change from Depression Anxiety and Stress Scale - 21 items
timeFrame: baseline, 2 months (post-intervention), 6 months (follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Consulta da dor, Serviço de Anestesiologia
Study officials:
affiliation: CINEICC - University of Coimbra
name: Sérgio Carvalho
role: PRINCIPAL_INVESTIGATOR
References: