Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy
BehavioralACT-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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Acceptance and Commitment TherapyExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
3, 6 and 12 months after the interventionSecondary outcomes
1
Headache
mean change in days of headache of at least moderate intensity, based on headache diary
Time frame
3, 6 and 12 months after the intervention2
Work participation
change in the self-reported number of hours with paid work or ordinary studies per week
Time frame
3, 6 and 12 months after the interventionOther outcomes
1
Change of level of cytokines in peripheral blood
Blood tests are collected before and after the intervention
Time frame
at baseline and at 3 months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov