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

NCT04210466 | Unknown

• 1 other identifier: SFRH/BD/112833/2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; Acceptance and Commitment Therapy (ACT); Compassion

Outcome Measures

Primary Outcomes (4)

• change from Numeric Pain Rating Scale at 2 months (post-intervention)

  Pain intensity - higher scores mean more pain intensity

  baseline, at 2 months (post-intervention)

• change from Pain Disability Index

  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

  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

  Depression, anxiety and stress symptoms - higher scores mean more depression, anxiety and stress symptoms

  baseline, 2 months (post-intervention), 6 months (follow-up)

Study Arms (2)

Acceptance & Commitment Therapy + Compassion (COMP.ACT)

EXPERIMENTAL

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

Behavioral: Acceptance & Commitment Therapy + Compassion (COMP.ACT)

Acceptance & Commitment Therapy (ACT)

ACTIVE COMPARATOR

an ACT intervention + 2 Q\&A sessions.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance & Commitment Therapy + Compassion (COMP.ACT) BEHAVIORAL

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 & Commitment Therapy + Compassion (COMP.ACT)

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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

Acceptance & Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

Consulta da dor, Serviço de Anestesiologia

Coimbra, Portugal

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sérgio Carvalho

  CINEICC - University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sérgio Carvalho

CONTACT

916365827; sergiocarvalho@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: January 7, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)