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

NCT04057144 | Completed

• 1 other identifier: 2019/503
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Mindfulness; Psychotherapy, Group; Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

  the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items

  44 weeks after end of treatment

Secondary Outcomes (11)

• pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

  8 weeks after end of treatment

• pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

  24 weeks after end of treatment

• pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

  3 years after end of treatment

• physical function

  8 weeks after end of treatment

• physical function

  24 weeks after end of treatment

Other Outcomes (3)

• attentional functioning

  8 weeks after end of treatment

• attentional functioning

  24 weeks after end of treatment

• attentional functioning

  44 weeks after end of treatment

Study Arms (3)

ACT with mindfulness

EXPERIMENTAL

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

Behavioral: ACT; Behavioral: mindfulness exercises and audio recordings

ACT without mindfulness

EXPERIMENTAL

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

Behavioral: ACT

Education program

ACTIVE COMPARATOR

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

Behavioral: Education program

Interventions

ACT 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.

ACT with mindfulness; ACT without mindfulness

mindfulness exercises and audio recordings 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 with mindfulness

Education program 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

Education program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Oslo University Hospital: collaborator
• University Hospital of North Norway: collaborator
• Haukeland University Hospital: collaborator

Study Sites (4)

Haukeland universitetssykehus

Bergen, Norway

Location

Oslo universitetssykehus

Oslo, Norway

Location

Norges arktiske universitet

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Nost TH, Woodhouse A, Dale LO, Hara KW, Steinsbekk A. Participants' experiences from group-based treatment at multidisciplinary pain centres - a qualitative study. Scand J Pain. 2021 Aug 30;22(2):365-373. doi: 10.1515/sjpain-2021-0099. Print 2022 Apr 26.

  PMID: 34453878 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Sound Recordings; Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Tormod Landmark, phd

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: August 20, 2020
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

NO (4)