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

Chronic Pain Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057144
• Other study ID #: 2019/503
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: August 2029

Study information

• Verified date: September 2022
• Source: St. Olavs Hospital
• Contact: Petter C Borchgrevink, md prof
• Phone: +47 72822494
• Email: petter.borchgrevink[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 486
• Est. completion date: August 2029
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Norway	Haukeland universitetssykehus	Bergen
Norway	Oslo universitetssykehus	Oslo
Norway	Norges arktiske universitet	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
St. Olavs Hospital	Haukeland University Hospital, Norwegian University of Science and Technology, Oslo University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	8 weeks after end of treatment
Other	attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	24 weeks after end of treatment
Other	attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	44 weeks after end of treatment
Primary	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	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	8 weeks after end of treatment
Secondary	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	24 weeks after end of treatment
Secondary	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	3 years after end of treatment
Secondary	physical function	according to the SF-36 Health Survey	8 weeks after end of treatment
Secondary	physical function	according to the SF-36 Health Survey	24 weeks after end of treatment
Secondary	physical function	according to the SF-36 Health Survey	44 weeks after end of treatment
Secondary	physical function	according to the SF-36 Health Survey	3 years after end of treatment
Secondary	mental health	according to the SF-36 Health Survey	8 weeks after end of treatment
Secondary	mental health	according to the SF-36 Health Survey	24 weeks after end of treatment
Secondary	mental health	according to the SF-36 Health Survey	44 weeks after end of treatment
Secondary	mental health	according to the SF-36 Health Survey	3 years after end of treatment