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

Not Applicable

Recruiting

• Conditions: Post-Concussion Syndrome; Post-Traumatic Headache
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT04614922
• Lead Sponsor: St. Olavs Hospital

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).

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-28
• Study Start: 2020-10-29
• Study First Posted: 2020-11-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-04
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postcincussion symptom burden	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 Outcome Measures

Name	Time	Method
Headache	3, 6 and 12 months after the intervention	mean change in days of headache of at least moderate intensity, based on headache diary
Work participation	3, 6 and 12 months after the intervention	change in the self-reported number of hours with paid work or ordinary studies per week

Trial Locations

Locations (1)

St Olavs Hospital Clinic of Physical Medicine and Rehabilitation; 🇳🇴 Trondheim, Norway