Clinical Trials Directory

Trials / Completed

CompletedNCT04057144

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

Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
667 (actual)
Sponsor
St. Olavs Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALACTAcceptance 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.
BEHAVIORALmindfulness exercises and audio recordingsmindfulness 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.
BEHAVIORALEducation programSelf-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

Timeline

Start date
2020-08-20
Primary completion
2024-08-30
Completion
2024-08-30
First posted
2019-08-15
Last updated
2025-06-25

Locations

4 sites across 1 country: Norway

Source: ClinicalTrials.gov record NCT04057144. Inclusion in this directory is not an endorsement.