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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Concussion Syndrome; Post-Traumatic Headache
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Toril Skandsen, PhD; Phone Number: +47 92692780; Email: toril.skandsen@ntnu.no
• Study Contact Backup: Name: Simen Berg Saksvik, PhD; Email: simen.b.saksvik@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital Clinic of Physical Medicine and Rehabilitation
    • Contact: Linda Fordal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy; Participation in a 4 week group program based on Acceptance and Commitment Therapy, individual councelling and home lessions.	Behavioral: 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.; Other Names: ACT
No Intervention: control group; Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
function measured by the Patient-specific Function Scale (PSFS)	The patient is asked to write down activities that they have difficulty with due to their PCS/PTH. They can report up to three activities. Then they are asked to rate their current ability to complete the activity on 11-point scale from 0 "unable to perform" to 10 "able to perform at prior level". Prior refers to the level experienced before the injury. At follow-up the activities they reported the first time are then presented to them, and they are asked to rate them on the same 11-point scale. The first activity the patient lists is used for scoring. A change of two points or more at follow-up is considered a clinically meaningful change.	3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache	mean change in days of headache of at least moderate intensity, based on headache diary	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	3, 6 and 12 months after the intervention
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of level of cytokines in peripheral blood	Blood tests are collected before and after the intervention	at baseline and at 3 months after the intervention

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Toril Skandsen, phd, Norwegian University of Science and Technology, INB; Study Director: Brit-Elin Lurud, md, St. Olavs Hospital, Clinic of Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache; Post-Concussion Syndrome; Post-Traumatic Headache
• Other Study ID Numbers: 150525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No