A New Approach in Chronic Pain; Acceptance & Commitment Therapy-Exposure & Perspective Taking (ACT-EPT) (ACT-EPT)

March 6, 2019 updated by: Maastricht University Medical Center

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Heerlen, Netherlands, 6411 ND
        • Winnock Zorg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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;

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT-ETP
Cognitive behavioral treatment
Behavioral: Acceptance & Commitment Therapy-Exposure and Perspective Taking
To increase patients' participation by improving their level of coping with chronic pain.
No Intervention: Usual care
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change between all weekly time-points SF-12 until 16 weeks after randomisation will be calculated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL63888.068.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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