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

NCT03481504 | Completed

• 1 other identifier: NL63888.068.17
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  Change between all weekly time-points SF-12 until 16 weeks after randomisation will be calculated

Study Arms (2)

ACT-ETP

EXPERIMENTAL

Cognitive behavioral treatment

Behavioral: Acceptance & Commitment Therapy-Exposure and Perspective Taking

Usual care

NO INTERVENTION

no intervention

Interventions

Acceptance & Commitment Therapy-Exposure and Perspective Taking BEHAVIORAL

To increase patients' participation by improving their level of coping with chronic pain.

ACT-ETP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Winnock Zorg

Heerlen, 6411 ND, Netherlands

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The particpant is kept naieve about the fact that the moment of starting the intervention is randomized but coiuld not be blinded for the intervention. The outcome assessor and investigator are blinded for randomization
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 29, 2018
• Study Start: March 10, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: March 7, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)