Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2024-08-30

Brief Summary

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As non-pharmacological alternatives, psychosocial treatments have been recommended for chronic pain management. One such treatment is Acceptance and Commitment Therapy (ACT). ACT is a cognitive behavior therapy based on Relational Frame Theory, a comprehensive theory about language and cognition. This treatment intends to help patients identify values ("what is truly meaningful to them") and to set goals and take action according to their values. ACT has research support in the treatment of several mental health problems. Moreover patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so that these will have less impact on functioning and action. Among patients with chronic pain, several small clinical trials have shown that ACT is more effective than other treatments in terms of increasing function and improving mental health. ACT in combination with mindfulness training has not been tested so far. Further methodologically robust trials are required. This study will therefore examine whether ACT is more effective for chronic pain than an education program, and whether adding daily mindfulness training will improve the outcome, in a large sample of patients from four multidisciplinary pain centers.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a three group randomized controlled trial with 162 patient in each group, six different measurement points, of which pre-treatment and 52 weeks after start of the treatment are the crucial points.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACT with mindfulness

4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8

Group Type EXPERIMENTAL

ACT

Intervention Type BEHAVIORAL

Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.

mindfulness exercises and audio recordings

Intervention Type BEHAVIORAL

mindfulness exercises introduced in the ACT sessions. In addition daily home meditation exercises based on the program developed by Kabat-Zinn 2005 and with help of audio recordings.

ACT without mindfulness

4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8

Group Type EXPERIMENTAL

ACT

Intervention Type BEHAVIORAL

Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.

Education program

Self-management education program during 8 weeks in groups of 8.

Group Type ACTIVE_COMPARATOR

Education program

Intervention Type BEHAVIORAL

Self-management education program. Information given by a qualified health professional on pain and symptom management, stress, sleep, eating habits, mental health problems. Group discussions about thoughts and experiences.

communication skills and physical activity

Interventions

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ACT

Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.

Intervention Type BEHAVIORAL

mindfulness exercises and audio recordings

mindfulness exercises introduced in the ACT sessions. In addition daily home meditation exercises based on the program developed by Kabat-Zinn 2005 and with help of audio recordings.

Intervention Type BEHAVIORAL

Education program

Self-management education program. Information given by a qualified health professional on pain and symptom management, stress, sleep, eating habits, mental health problems. Group discussions about thoughts and experiences.

communication skills and physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* referred to one of the pain clinics in Oslo (200), Trondheim (200), Bergen (100) or Tromsø (100)
* primary diagnosis of chronic pain lasting for at least 6 months

Exclusion Criteria

* severe somatic disease
* severe mental disorder (ongoing mania, psychosis, suicidal ideation, substance abuse/addiction
* not able to communicate in Norwegian
* needing 24-hour personal assistance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No