Post-Concussion SyndromeNCT04614922
Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms
A study testing Acceptance and Commitment Therapy in people with Post-Concussion Syndrome and Post-Traumatic Headache, run by St. Olavs Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Concussion Syndrome, Post-Traumatic Headache
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- 29 Oct 2020to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital Clinic of Physical Medicine and Rehabilitation
Trondheim
About this study
Official title: Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled 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.
Read the 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).
- Conditions
- Post-Concussion Syndrome, Post-Traumatic Headache
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy
- Medical subject headings
- Post-Concussion Syndrome, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions. Receives: Behavioral: Acceptance and Commitment Therapy |
| control group | No intervention | Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3, 6 and 12 months after the intervention
Secondary outcomes (2)
Headache
mean change in days of headache of at least moderate intensity, based on headache diary
Measured: 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
Measured: 3, 6 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start29 Oct 2020
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Toril Skandsen, phd, Principal investigator, Norwegian University of Science and Technology, INBBrit-Elin Lurud, md, Study director, St. Olavs hospital, Clinic of Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614922
- Sponsor's protocol ID
- 150525
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04614922
- Acronym / sponsor ID
- 150525
- Conditions
- Post-Concussion Syndrome, Post-Traumatic Headache
- Keywords
- Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyParticipation 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTACT-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. | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Postcincussion symptom burden
Time frame: 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).
2 secondary outcomes
Headache
Time frame: 3, 6 and 12 months after the intervention
Work participation
Time frame: 3, 6 and 12 months after the intervention
Results and safety
The study was stopped early (reason given: We could not achieve the expected number of participants within reasonable time. We decided to analyse the data with fewer participants than initially planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
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Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
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Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toril Skandsen, phd principal investigator
Norwegian University of Science and Technology, INB
Brit-Elin Lurud, md study director
St. Olavs hospital, Clinic of Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Post-Concussion Syndrome and Post-Traumatic Headache, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We could not achieve the expected number of participants within reasonable time. We decided to analyse the data with fewer participants than initially planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postcincussion symptom burden (time frame: 3, 6 and 12 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.