Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms
Study Details
Study Description
Brief Summary
The investigators aim to evaluate effects of an outpatient rehabilitation program based on Acceptance and Commitment Therapy compared to usual care on function in patients with post-concussion syndrome (PCS) and post-traumatic headache (PTH). This study builds on the investigators' previous observational studies and treatment studies in this patient group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study is run in an outpatient setting at the Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway. All patients are also participants in the observational study: "Minimal and mild head injury: an exercise and outpatient follow-up study at St. Olavs Hospital" (REK number 2018/2159).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acceptance and Commitment Therapy
|
Behavioral: Acceptance and Commitment Therapy
ACT-based rehabilitation is an interdisciplinary group rehabilitation which includes 7 sessions of group-based ACT therapy. Each session lasts 2½ hours and is offered twice a week. The ACT sessions will be based on a detailed intervention manual, developed specifically for group treatment. Each group will include a maximum of eight patients. The patients are asked to do homework between each ACT-group session.
Other Names:
Behavioral: Care as usual
a phone call from a therapist for counselling and psychological support
|
| Other: control group
|
Behavioral: Care as usual
a phone call from a therapist for counselling and psychological support
|
Outcome Measures
Primary Outcome Measures
- function measured by the Patient-specific Function Scale (PSFS) [3 months after the intervention]
The patient is asked to write down activities that they have difficulty with due to their PCS/PTH. They can report up to three activities. Then they are asked to rate their current ability to complete the activity on 11-point scale from 0 "unable to perform" to 10 "able to perform at prior level". Prior refers to the level experienced before the injury. At follow-up the activities they reported the first time are then presented to them, and they are asked to rate them on the same 11-point scale. The first activity the patient lists is used for scoring. A change of two points or more at follow-up is considered a clinically meaningful change.
Secondary Outcome Measures
- mean change in days of headache of at least moderate intensity [3 months after the intervention]
- mean change in days of headache of at least moderate intensity [6 months after the intervention]
- mean change in days of headache of at least moderate intensity [12 months after the intervention]
- the score on Rivermead postconcussion symptom questionnaire [3 months after the intervention]
a list of 13 common postconcussion somatic, emotional and cognitive symptoms
- the score on Rivermead postconcussion symptom questionnaire [6 months after the intervention]
a list of 13 common postconcussion somatic, emotional and cognitive symptoms
- the score on Rivermead postconcussion symptom questionnaire [12 months after the intervention]
a list of 13 common postconcussion somatic, emotional and cognitive symptoms
- change in the self-reported number of hours with paid work or ordinary studies per week [3 months after the intervention]
- change in the self-reported number of hours with paid work or ordinary studies per week [6 months after the intervention]
- change in the self-reported number of hours with paid work or ordinary studies per week [12 months after the intervention]
Other Outcome Measures
- Change of level of cytokines in peripheral blood [at baseline and at 3 months after the intervention]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Having sustained a minimal HI or MTBI
-
PCS/ PTH had evolved within 1 week after the head trauma.
-
At least one post-concussion symptoms of at least moderate degree, that affects daily life.
-
6 months post-injury.
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First line treatment has been tried, e.g. psychoeducation, increase of physical activity and pharmacological treatments for headache
Exclusion Criteria:
-
More than 5 years since last injury.
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Symptoms are better explained by other conditions.
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Severe communication problems, typically due to poor knowledge of Norwegian.
-
Severe psychiatric, neurological, somatic or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Olavs Hospital Clinic of Physical Medicine and Rehabilitation | Trondheim | Norway |
Sponsors and Collaborators
- St. Olavs Hospital
- Norwegian University of Science and Technology
Investigators
- Principal Investigator: Toril Skandsen, phd, Norwegian University of Science and Technology, INB
- Study Director: Bjørn Skogstad, md, St. Olavs hospital, Clinic of Physical Medicine and Rehabilitation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 150525