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Clinical Trials/NCT04614922
NCT04614922
Recruiting
Not Applicable

Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled Trial

St. Olavs Hospital1 site in 1 country48 target enrollmentOctober 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Concussion Syndrome
Sponsor
St. Olavs Hospital
Enrollment
48
Locations
1
Primary Endpoint
Postcincussion symptom burden
Status
Recruiting
Last Updated
9 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 29, 2020
End Date
November 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Headache(3, 6 and 12 months after the intervention)
  • Work participation(3, 6 and 12 months after the intervention)

Study Sites (1)

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