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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
ACT
mindfulness exercises and audio recordings
Education program
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Mindfulness, Psychotherapy, Group, Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland universitetssykehusRecruiting
  • Oslo universitetssykehusRecruiting
  • Norges arktiske universitetRecruiting
  • St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ACT with mindfulness

ACT without mindfulness

Education program

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
physical function
according to the SF-36 Health Survey
physical function
according to the SF-36 Health Survey
physical function
according to the SF-36 Health Survey
physical function
according to the SF-36 Health Survey
mental health
according to the SF-36 Health Survey
mental health
according to the SF-36 Health Survey
mental health
according to the SF-36 Health Survey
mental health
according to the SF-36 Health Survey

Full Information

First Posted
August 13, 2019
Last Updated
September 30, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Oslo University Hospital, University Hospital of North Norway, Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04057144
Brief Title
Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain
Acronym
MUST
Official Title
Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Oslo University Hospital, University Hospital of North Norway, Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Mindfulness, Psychotherapy, Group, Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
486 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT with mindfulness
Arm Type
Experimental
Arm Description
4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8
Arm Title
ACT without mindfulness
Arm Type
Experimental
Arm Description
4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8
Arm Title
Education program
Arm Type
Active Comparator
Arm Description
Self-management education program during 8 weeks in groups of 8.
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
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
Intervention Name(s)
mindfulness exercises and audio recordings
Intervention Description
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
Intervention Name(s)
Education program
Intervention Description
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
Primary Outcome Measure Information:
Title
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Description
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
Time Frame
44 weeks after end of treatment
Secondary Outcome Measure Information:
Title
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Description
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
Time Frame
8 weeks after end of treatment
Title
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Description
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
Time Frame
24 weeks after end of treatment
Title
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Description
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
Time Frame
3 years after end of treatment
Title
physical function
Description
according to the SF-36 Health Survey
Time Frame
8 weeks after end of treatment
Title
physical function
Description
according to the SF-36 Health Survey
Time Frame
24 weeks after end of treatment
Title
physical function
Description
according to the SF-36 Health Survey
Time Frame
44 weeks after end of treatment
Title
physical function
Description
according to the SF-36 Health Survey
Time Frame
3 years after end of treatment
Title
mental health
Description
according to the SF-36 Health Survey
Time Frame
8 weeks after end of treatment
Title
mental health
Description
according to the SF-36 Health Survey
Time Frame
24 weeks after end of treatment
Title
mental health
Description
according to the SF-36 Health Survey
Time Frame
44 weeks after end of treatment
Title
mental health
Description
according to the SF-36 Health Survey
Time Frame
3 years after end of treatment
Other Pre-specified Outcome Measures:
Title
attentional functioning
Description
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
Time Frame
8 weeks after end of treatment
Title
attentional functioning
Description
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
Time Frame
24 weeks after end of treatment
Title
attentional functioning
Description
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
Time Frame
44 weeks after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petter C Borchgrevink, md prof
Phone
+47 72822494
Email
petter.borchgrevink@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter C Borchgrevink, md prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland universitetssykehus
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo universitetssykehus
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Name
Norges arktiske universitet
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petter C Borchgrevink, md prof
Phone
0047 72822494
Email
petter.borchgrevink@ntnu.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
34453878
Citation
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.
Results Reference
derived

Learn more about this trial

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

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