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

Primary Purpose

Post-Concussion Syndrome, Post-Traumatic Headache

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Acceptance and Commitment Therapy

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St Olavs Hospital Clinic of Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acceptance and Commitment Therapy

control group

Arm Description

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

Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Headache

mean change in days of headache of at least moderate intensity, based on headache diary

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).

Work participation

change in the self-reported number of hours with paid work or ordinary studies per week

Full Information

NCT ID

NCT04614922

First Posted

October 26, 2020

Last Updated

July 25, 2023

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT04614922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 29, 2020 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Concussion Syndrome, Post-Traumatic Headache

Keywords

Acceptance and Commitment Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acceptance and Commitment Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

Standard care, i.e. follow-up as needed, to some degree dependent on current capacity of therapists.

Intervention Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy

Other Intervention Name(s)

ACT

Intervention Description

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.

Primary Outcome Measure Information:

Title

function measured by the Patient-specific Function Scale (PSFS)

Description

Time Frame

3 months after the intervention

Secondary Outcome Measure Information:

Title

Headache

Description

mean change in days of headache of at least moderate intensity, based on headache diary

Time Frame

3, 6 and 12 months after the intervention

Title

Postcincussion symptom burden

Description

Time Frame

3, 6 and 12 months after the intervention

Title

Work participation

Description

change in the self-reported number of hours with paid work or ordinary studies per week

Time Frame

3, 6 and 12 months after the intervention

Other Pre-specified Outcome Measures:

Title

Change of level of cytokines in peripheral blood

Description

Blood tests are collected before and after the intervention

Time Frame

at baseline and at 3 months after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Toril Skandsen, phd

Phone

+47 92692780

toril.skandsen@ntnu.no

First Name & Middle Initial & Last Name or Official Title & Degree

Simen Berg Saksvik, PhD

simen.b.saksvik@ntnu.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toril Skandsen, phd

Organizational Affiliation

Norwegian University of Science and Technology, INB

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brit-Elin Lurud, md

Organizational Affiliation

St. Olavs hospital, Clinic of Rehabilitation

Official's Role

Study Director

Facility Information:

Facility Name

St Olavs Hospital Clinic of Physical Medicine and Rehabilitation

City

Trondheim

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Fordal

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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