Post-Concussion Syndrome, Post-Traumatic Headache
Conditions
Keywords
Acceptance and Commitment Therapy
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.
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).
Interventions
BEHAVIORALAcceptance 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.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postcincussion symptom burden | 3, 6 and 12 months after the intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache | 3, 6 and 12 months after the intervention | mean change in days of headache of at least moderate intensity, based on headache diary |
| Work participation | 3, 6 and 12 months after the intervention | change in the self-reported number of hours with paid work or ordinary studies per week |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORToril Skandsen, phd
Norwegian University of Science and Technology, INB
STUDY_DIRECTORBrit-Elin Lurud, md
St. Olavs hospital, Clinic of Rehabilitation
Outcome results
None listed