Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

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Post-Concussion Syndrome Post-Traumatic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acceptance and Commitment Therapy

Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type 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.

control group

Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acceptance 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ACT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No