Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms (NCT04614922) | Clinical Trial Compass
TerminatedNot Applicable
Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms
Stopped: We could not achieve the expected number of participants within reasonable time. We decided to analyse the data with fewer participants than initially planned.
Norway48 participantsStarted 2020-10-29
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postcincussion symptom burden
Timeframe: 3, 6 and 12 months after the intervention