Chronic PainMUSTNCT04057144
Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain
A study testing ACT, mindfulness exercises and audio recordings and Education program in people with Chronic Pain, run by St. Olavs Hospital at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ACT, mindfulness exercises and audio recordings and Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 4 sitesNorway
- Study dates
- 20 Aug 2020to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland universitetssykehus
Bergen
Oslo universitetssykehus
Oslo
Norges arktiske universitet
Tromsø
St Olavs Hospital
Trondheim
About this study
Official title: Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study
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
- Being tested
- ACT, mindfulness exercises and audio recordings, Education program
- Keywords
- Mindfulness, Psychotherapy, Group, Behavior Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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 recordingsBehavioural
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 programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ACT with mindfulness | Experimental | 4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 Receives: 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 Receives: Behavioral: ACT |
| Education program | Active comparator | Self-management education program during 8 weeks in groups of 8. Receives: Behavioral: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 44 weeks after end of treatment
Secondary outcomes (11)
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
Measured: 8 weeks after end of treatment
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
Measured: 24 weeks after end of treatment
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
Measured: 3 years after end of treatment
physical function
according to the SF-36 Health Survey
Measured: 8 weeks after end of treatment
physical function
according to the SF-36 Health Survey
Measured: 24 weeks after end of treatment
physical function
according to the SF-36 Health Survey
Measured: 44 weeks after end of treatment
physical function
according to the SF-36 Health Survey
Measured: 3 years after end of treatment
mental health
according to the SF-36 Health Survey
Measured: 8 weeks after end of treatment
mental health
according to the SF-36 Health Survey
Measured: 24 weeks after end of treatment
mental health
according to the SF-36 Health Survey
Measured: 44 weeks after end of treatment
mental health
according to the SF-36 Health Survey
Measured: 3 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start20 Aug 2020
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Oslo University Hospital, University Hospital of North Norway, Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Tormod Landmark, phd, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057144
- Sponsor's protocol ID
- 2019/503
- Acronym
- MUST
- Status last verified
- Jun 2025
- First submitted
- 13 Aug 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34453878
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study
- ClinicalTrials.gov ID
- NCT04057144
- Acronym / sponsor ID
- MUST / 2019/503
- Conditions
- Chronic Pain
- Keywords
- Mindfulness, Psychotherapy, Group, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Oslo University Hospital, University Hospital of North Norway, Haukeland University Hospital
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT with mindfulness | Experimental | Behavioral: ACT, Behavioral: mindfulness exercises and audio recordings4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 |
| ACT without mindfulness | Experimental | Behavioral: ACT4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8 |
| Education program | Active comparator | Behavioral: Education programSelf-management education program during 8 weeks in groups of 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTAcceptance 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. | Behavioural | ACT with mindfulness, ACT without mindfulness |
| mindfulness 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. | Behavioural | ACT with mindfulness |
| Education 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 | Behavioural | Education program |
Primary outcome
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Time frame: 44 weeks after end of treatment
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
11 secondary outcomes
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Time frame: 8 weeks after end of treatment
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Time frame: 24 weeks after end of treatment
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Time frame: 3 years after end of treatment
physical function
Time frame: 8 weeks after end of treatment
physical function
Time frame: 24 weeks after end of treatment
physical function
Time frame: 44 weeks after end of treatment
physical function
Time frame: 3 years after end of treatment
mental health
Time frame: 8 weeks after end of treatment
mental health
Time frame: 24 weeks after end of treatment
mental health
Time frame: 44 weeks after end of treatment
mental health
Time frame: 3 years after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 34453878Nost 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tormod Landmark, phd principal investigator
St. Olavs Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT, mindfulness exercises and audio recordings and Education program in people with Chronic Pain, run by St. Olavs Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity measured by the Norwegian Brief Pain Inventory (BPI) (time frame: 44 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04057144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.