Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled Trial

Conditions
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Post-Concussion Syndrome, Post-Traumatic Headache

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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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. 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. Symptoms are better explained by other conditions. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy<br>Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions. | Behavioral: Acceptance and Commitment Therapy<br>* 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.<br>* Other names: ACT;|
| No Intervention: control group<br>Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function measured by the Patient-specific Function Scale (PSFS) | 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. | 3 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache | mean change in days of headache of at least moderate intensity, based on headache diary | 3, 6 and 12 months after the intervention | 
| Postcincussion symptom burden | The Rivermead postconcussion symptom questionnaire. The scale measures 13 common postconcussion somatic, emotional and cognitive symptoms on a range from 0 (no symptoms) to 64 (all symptoms graded as severe). | 3, 6 and 12 months after the intervention | 
| Work participation | change in the self-reported number of hours with paid work or ordinary studies per week | 3, 6 and 12 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy