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…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this study is the SF-12.
Secondary outcome
Secondaire uitkomstmaten zijn de AAQ-II-P, PIPS, PSK, PDI, VAS pijn, IPA,
FFMQ-SF en de ELS. De PSK wordt enkel gebruikt voor therapie doeleinden.
Background summary
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.
Study objective
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
Study design: The randomized N-of -1 design 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.
Methodological details of all aspects of the design will be explained further
in the protocol. It is a pilot study.
Intervention
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.
Study burden and risks
: No risks are associated with this study. The load for the participants
consists of 3 treatment seesions, the weekly filling out of a limited amount of
questionnaires, a meeting with the rehabilitation physician 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. Total load is 13 hours.
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.
Universiteistsingel 40
Maastricht 6200 MD
NL
Universiteistsingel 40
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
* The patient is diagnosed as having chronic pain, is referred to Winnock 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
A potential subject who meets any of the following criteria will be excluded from participation in this study. The judgement of the experienced rehabilitation physician involved in the screening is leading:
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63888.068.17 |