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

NCT04614922 | Recruiting

• 1 other identifier: 150525
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Concussion Syndrome; Post-Traumatic Headache

Keywords

Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  3, 6 and 12 months after the intervention

Secondary Outcomes (2)

• Headache

  3, 6 and 12 months after the intervention

• Work participation

  3, 6 and 12 months after the intervention

Other Outcomes (1)

• Change of level of cytokines in peripheral blood

  at baseline and at 3 months after the intervention

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

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

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.

Interventions

Acceptance and Commitment Therapy 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.

Also known as: ACT

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital Clinic of Physical Medicine and Rehabilitation

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome; Post-Traumatic Headache

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Toril Skandsen, phd

  Norwegian University of Science and Technology, INB

  PRINCIPAL INVESTIGATOR

• Brit-Elin Lurud, md

  St. Olavs hospital, Clinic of Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Toril Skandsen, phd

CONTACT

+47 92692780; toril.skandsen@ntnu.no

Simen Berg Saksvik, PhD

CONTACT

simen.b.saksvik@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 4, 2020
• Study Start: October 29, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)