Chronic PainACT-EPTNCT03481504
A New Approach in Chronic Pain; Acceptance & Commitment Therapy-Exposure & Perspective Taking (ACT-EPT)
A study testing Acceptance & Commitment Therapy-Exposure and Perspective Taking in people with Chronic Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Background: Chronic pain is a highly prevalent phenomenon with a large impact on the individual's wellbeing. Acceptance and Commitment Therapy (ACT) can be used to help patients relate to chronic pain in a way that helps improve their quality of life. 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?
- Acceptance & Commitment Therapy-Exposure and Perspective Taking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Mar 2018to 10 Dec 2018
- 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
- The patient is diagnosed as having chronic pain, is referred to Winnock Zorg rehabilitation center, location Heerlen or Arnhem, and is registered to receive treatment at Winnock Zorg rehabilitation center;
- The patient has pain of the musculoskeletal system
- The patient has pain for longer than 6 weeks
- The patient is medically stable
- The patient has functional limitations
- The medical history and examination of the patient do not indicate further somatic diagnostics and treatment
Show all 12Show fewer
- The patient has unwanted psychosocial consequences from the pain, such as in activities of daily life, relationships, work and social role
- Social and psychological factors are complex and play an important role in maintaining the pain, as is assessed by a rehabilitation physician expert
- The patient shows to have insights in his/her functional limitations, as is assessed by a rehabilitation physician expert
- The patient has an active attitude in finding solutions for his/her problem, as is assessed by a rehabilitation physician expert
- The assessment of the patient by a rehabilitation physician expert indicates that the patient is open to receive a cognitive therapy for pain management;
- The patient is at least 18 years old;
Who cannot join
- The patient has a history of diagnosed psychotic illness or manic episode;
- The patient has a diagnosed systematic or malignant disease;
- The patient has had a form of Acceptance and Commitment Therapy in the past;
- The patient is using a type of CBT at the moment of the study;
- The patient has a reported substance abuse within 6 months before the trial;
- The patient has a serious medical condition which can be expected to interfere with participation in the study.
- The patient has an inadequate understanding of the written and spoken Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Protocol of a Single Case Methodology Experiement Exploring the Effectiveness and Feasibility of an Exposure-centered ACT Intervention for Chronic Pain Patients: A Pilot Study
Background: Chronic pain is a highly prevalent phenomenon with a large impact on the individual's wellbeing. Acceptance and Commitment Therapy (ACT) can be used to help patients relate to chronic pain in a way that helps improve their quality of life. This paper introduces an ACT protocol specific to chronic pain patients: ACT- Exposure and Perspective Taking (ACT-EPT). Aspects specific to this therapy are the focus on exposure as a means to elicit behavioural and emotional change regarding pain experience and it's format as a compact individual therapy.
Objectives: Investigators conduct a single case experimental study (ABA design) with a multiple baseline design, aimed at assessing the effectiveness of the experimental ACT-EPT protocol (phase B) compared to usual care (phase A) in individual chronic pain patients. Outcomes include the increase of participation in daily life and health related quality of life, measured with the Short Form-12 (SF-12). Quantitative results will be combined with qualitative results from interviews in a mixed methods design.
Read more
Participants: Five adults with chronic pain referred to a rehabilitation centre (≥18 years old).
Methods: Phases A and B together take 16 weeks for each participant, during which weekly quantitative measurements will be taken. The length of the first phase A will be randomised. The intervention (phase B) consists of weekly ACT-EPT sessions with a maximum of 3 sessions of approximately 90 minutes each. Individual interviews will take place after the last quantitative measurements. These focus on two topics: psychological processes of change and evaluating the intervention.
Read the detailed description
Rationale: Chronic pain is a phenomenon with a large impact on the individual's wellbeing and is a problem with a large global burden of disease, with a prevalence of 19 to 20% in European adults and an annual cost of €200 billion in Europe. Apart from causing physical suffering, chronic pain can lead to depression, suicidal thoughts and disrupted social relationships and can cause impairments in everyday life tasks and activities. Despite the seriousness of chronic pain, not all chronic pain patients receive adequate treatment. One cognitive behavioral therapy treatment which is used in the Netherlands for chronic pain patients is the Acceptance and Commitment Therapy (ACT). However, the way in which this therapy is delivered in the Netherlands tends to take many sessions. It therefore seems attractive to investigate a short version of this protocol, which was developed in Sweden. This short version, ACT-EPT, is already being used in the Netherlands on a small scale but its effects have not yet been studied. The current paper proposes a pilot study with an innovative N-of-1 design to investigate this therapy's effectiveness.
Objective: Investigating the effectiveness of an experimental protocol of Acceptance and Commitment Therapy-Exposure \& Perspective Taking (ACT-EPT) compared to usual care in individual chronic pain patients on the increase of their participation in daily life and health related quality of life, as measured with the SF-12 in a study with a single case experimental methodology.
Study design: The randomized n=1 study combines a quantitative and a consecutive qualitative part (mixed methods). Each participant receives the intervention and serves as his or her own control in an AB design. In phase A, all participants continue the care they already received which will be recorded as their care as usual. At a random moment, phase A will end and participants will start their intervention, thus entering phase B. This study randomizes participants on the duration of phase A, which means that the lengths of phases A and B differs among participants. The total study period (A+B) over which participants will receive weekly measurements is the same for all participants (16 weeks). Results will be presented on an individual basis according to the single case experimental methodology. In the last week of the total period, participants will be invited for an interview with a researcher focussing on their experience living with chronic pain and to evaluate the intervention. This interview will take place in the participants' own environment. Methodological details of all aspects of the design will be explained further in the protocol.
Study population: Chronic pain patients of 18 years or older referred the Rehabilitation Centre Winnock Zorg in Heerlen or Arnhem for treatment (n=5).
Intervention: The ACT-EPT treatment protocol is a type of acceptance-based cognitive behavioral therapy, aimed to increase patients' participation by improving their level of coping with chronic pain. The therapy takes between one and three sessions of about an hour and a half each.
Main study parameters/endpoints: The primary outcome measure of this study is the SF-12. Secondary outcome measures are the AAQ-II-P, PIPS, PSK, PDI, NPRS , IPA, FFMQ-SF and the ELS. The PSK will only be used for clinical purposes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with this study. The load for the participants consists of the weekly filling out of a limited amount of questionnaires and the participation in a one hour interview. The number of questionnaires that patients are asked to fill out differs per week, with a lowest load per week of 8 minutes and the highest load at baseline of 55 minutes. The total time taken to fill out all questionnaires over the 16 week period is 6 hours and 55 minutes, with an average of 26 minutes per week. Detailed information can be found in the questionnaires table in the protocol. The intervention takes between one and three sessions of about an hour and a half each, and is given in the rehabilitation centre.
- Conditions
- Chronic Pain
- Being tested
- Acceptance & Commitment Therapy-Exposure and Perspective Taking
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance & Commitment Therapy-Exposure and Perspective TakingBehavioural
To increase patients' participation by improving their level of coping with chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| ACT-ETP | Experimental | Cognitive behavioral treatment Receives: Behavioral: Acceptance & Commitment Therapy-Exposure and Perspective Taking |
| Usual care | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12
The SF-12 measures overall quality of life and includes items that assess participation. The SF-12 is a frequently used measure and has shown to have good internal consistency, reliability, construct validity and responsiveness in patients with chronic (low) back pain (Luo et al., 2003). The measure is a subset of 12 items from the SF-36 including 6 items from the physical summary measure (PCS) and 6 items from the mental summary measure (MCS).
Measured: Change between all weekly time-points SF-12 until 16 weeks after randomisation will be calculated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start10 Mar 2018
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Single case methodology with a multple baseline design in a mixed methods approach in which a quantitative approach will be followed by a qualitative approach. The star of the experiemental intervention will be randomized
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481504
- Sponsor's protocol ID
- NL63888.068.17
- Acronym
- ACT-EPT
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol of a Single Case Methodology Experiement Exploring the Effectiveness and Feasibility of an Exposure-centered ACT Intervention for Chronic Pain Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03481504
- Acronym / sponsor ID
- ACT-EPT / NL63888.068.17
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 29 Mar 2018 (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.
Background: Chronic pain is a highly prevalent phenomenon with a large impact on the individual's wellbeing. Acceptance and Commitment Therapy (ACT) can be used to help patients relate to chronic pain in a way that helps improve their quality of life. This paper introduces an ACT protocol specific to chronic pain patients: ACT- Exposure and Perspective Taking (ACT-EPT). Aspects specific to this therapy are the focus on exposure as a means to elicit behavioural and emotional change regarding pain experience and it's format as a compact individual therapy.
Objectives: Investigators conduct a single case experimental study (ABA design) with a multiple baseline design, aimed at assessing the effectiveness of the experimental ACT-EPT protocol (phase B) compared to usual care (phase A) in individual chronic pain patients. Outcomes include the increase of participation in daily life and health related quality of life, measured with the Short Form-12 (SF-12). Quantitative results will be combined with qualitative results from interviews in a mixed methods design.
Participants: Five adults with chronic pain referred to a rehabilitation centre (≥18 years old).
Methods: Phases A and B together take 16 weeks for each participant, during which weekly quantitative measurements will be taken. The length of the first phase A will be randomised. The intervention (phase B) consists of weekly ACT-EPT sessions with a maximum of 3 sessions of approximately 90 minutes each. Individual interviews will take place after the last quantitative measurements. These focus on two topics: psychological processes of change and evaluating the intervention.
Detailed description
Rationale: Chronic pain is a phenomenon with a large impact on the individual's wellbeing and is a problem with a large global burden of disease, with a prevalence of 19 to 20% in European adults and an annual cost of €200 billion in Europe. Apart from causing physical suffering, chronic pain can lead to depression, suicidal thoughts and disrupted social relationships and can cause impairments in everyday life tasks and activities. Despite the seriousness of chronic pain, not all chronic pain patients receive adequate treatment. One cognitive behavioral therapy treatment which is used in the Netherlands for chronic pain patients is the Acceptance and Commitment Therapy (ACT). However, the way in which this therapy is delivered in the Netherlands tends to take many sessions. It therefore seems attractive to investigate a short version of this protocol, which was developed in Sweden. This short version, ACT-EPT, is already being used in the Netherlands on a small scale but its effects have not yet been studied. The current paper proposes a pilot study with an innovative N-of-1 design to investigate this therapy's effectiveness.
Objective: Investigating the effectiveness of an experimental protocol of Acceptance and Commitment Therapy-Exposure \& Perspective Taking (ACT-EPT) compared to usual care in individual chronic pain patients on the increase of their participation in daily life and health related quality of life, as measured with the SF-12 in a study with a single case experimental methodology.
Study design: The randomized n=1 study combines a quantitative and a consecutive qualitative part (mixed methods). Each participant receives the intervention and serves as his or her own control in an AB design. In phase A, all participants continue the care they already received which will be recorded as their care as usual. At a random moment, phase A will end and participants will start their intervention, thus entering phase B. This study randomizes participants on the duration of phase A, which means that the lengths of phases A and B differs among participants. The total study period (A+B) over which participants will receive weekly measurements is the same for all participants (16 weeks). Results will be presented on an individual basis according to the single case experimental methodology. In the last week of the total period, participants will be invited for an interview with a researcher focussing on their experience living with chronic pain and to evaluate the intervention. This interview will take place in the participants' own environment. Methodological details of all aspects of the design will be explained further in the protocol.
Study population: Chronic pain patients of 18 years or older referred the Rehabilitation Centre Winnock Zorg in Heerlen or Arnhem for treatment (n=5).
Intervention: The ACT-EPT treatment protocol is a type of acceptance-based cognitive behavioral therapy, aimed to increase patients' participation by improving their level of coping with chronic pain. The therapy takes between one and three sessions of about an hour and a half each.
Main study parameters/endpoints: The primary outcome measure of this study is the SF-12. Secondary outcome measures are the AAQ-II-P, PIPS, PSK, PDI, NPRS , IPA, FFMQ-SF and the ELS. The PSK will only be used for clinical purposes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with this study. The load for the participants consists of the weekly filling out of a limited amount of questionnaires and the participation in a one hour interview. The number of questionnaires that patients are asked to fill out differs per week, with a lowest load per week of 8 minutes and the highest load at baseline of 55 minutes. The total time taken to fill out all questionnaires over the 16 week period is 6 hours and 55 minutes, with an average of 26 minutes per week. Detailed information can be found in the questionnaires table in the protocol. The intervention takes between one and three sessions of about an hour and a half each, and is given in the rehabilitation centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single case methodology with a multple baseline design in a mixed methods approach in which a quantitative approach will be followed by a qualitative approach. The star of the experiemental intervention will be randomized
| Arm | Type | Receives |
|---|---|---|
| ACT-ETP | Experimental | Behavioral: Acceptance & Commitment Therapy-Exposure and Perspective TakingCognitive behavioral treatment |
| Usual care | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient is diagnosed as having chronic pain, is referred to Winnock Zorg rehabilitation center, location Heerlen or Arnhem, and is registered to receive treatment at Winnock Zorg rehabilitation center;
- The patient has pain of the musculoskeletal system
- The patient has pain for longer than 6 weeks
- The patient is medically stable
- The patient has functional limitations
Key exclusion criteria (7 listed)
- The patient has a history of diagnosed psychotic illness or manic episode;
- The patient has a diagnosed systematic or malignant disease;
- The patient has had a form of Acceptance and Commitment Therapy in the past;
- The patient is using a type of CBT at the moment of the study;
- The patient has a reported substance abuse within 6 months before the trial;
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 |
|---|---|---|
| Acceptance & Commitment Therapy-Exposure and Perspective TakingTo increase patients' participation by improving their level of coping with chronic pain. | Behavioural | ACT-ETP |
Primary outcome
SF-12
Time frame: Change between all weekly time-points SF-12 until 16 weeks after randomisation will be calculated
The SF-12 measures overall quality of life and includes items that assess participation. The SF-12 is a frequently used measure and has shown to have good internal consistency, reliability, construct validity and responsiveness in patients with chronic (low) back pain (Luo et al., 2003). The measure is a subset of 12 items from the SF-36 including 6 items from the physical summary measure (PCS) and 6 items from the mental summary measure (MCS).
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 7 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance & Commitment Therapy-Exposure and Perspective Taking in people with Chronic Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
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 12 inclusion and 7 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
SF-12 (time frame: Change between all weekly time-points SF-12 until 16 weeks after randomisation will be calculated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.