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

Post-Concussion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04614922
• Other study ID #: 150525
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2020
• Est. completion date: November 2025

Study information

• Verified date: July 2023
• Source: St. Olavs Hospital
• Contact: Toril Skandsen, phd
• Phone: +47 92692780
• Email: toril.skandsen[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Concussion Syndrome
• Post-Traumatic Headache

Intervention

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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital Clinic of Physical Medicine and Rehabilitation	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Headache	mean change in days of headache of at least moderate intensity, based on headache diary	3, 6 and 12 months after the intervention
Secondary	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	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