Chronic PainCOMPACTNCT04210466
COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain
A study testing Acceptance & Commitment Therapy + Compassion (COMP.ACT) and Acceptance and Commitment Therapy (ACT) in people with Chronic Pain, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Acceptance & Commitment Therapy + Compassion (COMP.ACT) and Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Jan 2019to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pain diagnosis(es),
- age between 18-65,
- residence in center region of Portugal,
- Availability to attend sessions.
Who cannot join
- Symptoms of psychosis,
- Non-suicidal self-injury,
- Suicide ideation,
- Severe Depression,
- Substance Abuse.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Consulta da dor, Serviço de Anestesiologia
Coimbra
Teresa Lapa, PhD, teresalapa@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Acceptance & Commitment Therapy + Compassion (COMP.ACT), Acceptance and Commitment Therapy (ACT)
- Keywords
- chronic pain, Acceptance and Commitment Therapy (ACT), Compassion
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance & Commitment Therapy + Compassion (COMP.ACT)Behavioural
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
Acceptance and Commitment Therapy (ACT)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Acceptance & Commitment Therapy + Compassion (COMP.ACT) | Experimental | an ACT intervention + 2 sessions of explicit self-compassion meditation exercises. Receives: Behavioral: Acceptance & Commitment Therapy + Compassion (COMP.ACT) |
| Acceptance & Commitment Therapy (ACT) | Active comparator | an ACT intervention + 2 Q\&A sessions. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Numeric Pain Rating Scale at 2 months (post-intervention)
Pain intensity - higher scores mean more pain intensity
Measured: baseline, at 2 months (post-intervention)
change from Pain Disability Index
Pain disability - higher scores mean more pain disability
Measured: baseline, 2 months (post-intervention), 6 months (follow-up)
change from World Health Organization Quality of Life - Bref
Quality of Life - higher scores mean more quality of life
Measured: baseline, 2 months (post-intervention), 6 months (follow-up)
change from Depression Anxiety and Stress Scale - 21 items
Depression, anxiety and stress symptoms - higher scores mean more depression, anxiety and stress symptoms
Measured: baseline, 2 months (post-intervention), 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start7 Jan 2019
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sérgio Andrade Carvalho, University of Coimbra
- Investigators
- Sérgio Carvalho, Principal investigator, CINEICC - University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210466
- Sponsor's protocol ID
- SFRH/BD/112833/2015
- Acronym
- COMPACT
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMP.ACT: Testing the Effect of Explicit Self-compassion Exercises in an ACT Group Intervention for Chronic Pain
- ClinicalTrials.gov ID
- NCT04210466
- Acronym / sponsor ID
- COMPACT / SFRH/BD/112833/2015
- Conditions
- Chronic Pain
- Keywords
- chronic pain, Acceptance and Commitment Therapy (ACT), Compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance & Commitment Therapy + Compassion (COMP.ACT) | Experimental | Behavioral: Acceptance & Commitment Therapy + Compassion (COMP.ACT)an ACT intervention + 2 sessions of explicit self-compassion meditation exercises. |
| Acceptance & Commitment Therapy (ACT) | Active comparator | Behavioral: Acceptance and Commitment Therapy (ACT)an ACT intervention + 2 Q\&A sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic pain diagnosis(es),
- age between 18-65,
- residence in center region of Portugal,
- Availability to attend sessions.
Key exclusion criteria (5 listed)
- Symptoms of psychosis,
- Non-suicidal self-injury,
- Suicide ideation,
- Severe Depression,
- Substance Abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Acceptance & Commitment Therapy + Compassion (COMP.ACT) |
| 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 | Behavioural | Acceptance & Commitment Therapy (ACT) |
Primary outcome
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
change from Pain Disability Index
Time frame: baseline, 2 months (post-intervention), 6 months (follow-up)
Pain disability - higher scores mean more pain disability
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sérgio Carvalho principal investigator
CINEICC - University of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance & Commitment Therapy + Compassion (COMP.ACT) and Acceptance and Commitment Therapy (ACT) in people with Chronic Pain, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Carvalho (916365827, sergiocarvalho@fpce.uc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from Numeric Pain Rating Scale at 2 months (post-intervention) (time frame: baseline, at 2 months (post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.