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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions. |
|
| control group | No Intervention | Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Work participation | change in the self-reported number of hours with paid work or ordinary studies per week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of level of cytokines in peripheral blood | Blood tests are collected before and after the intervention | at baseline and at 3 months after the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toril Skandsen, phd | Contact | +47 92692780 | toril.skandsen@ntnu.no | |
| Simen Berg Saksvik, PhD | Contact | simen.b.saksvik@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Toril Skandsen, phd | Norwegian University of Science and Technology, INB | Principal Investigator |
| Brit-Elin Lurud, md | St. Olavs hospital, Clinic of Rehabilitation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital Clinic of Physical Medicine and Rehabilitation | Recruiting | Trondheim | Norway |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 3, 6 and 12 months after the intervention |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |