e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury

May 8, 2023 updated by: Aglaia Zedlitz, Universiteit Leiden

Fatigue is a common, persistent consequence of acquired brain injury (ABI). Research into treatments that may alleviate post-ABI fatigue is been limited. Pharmacological treatment (methylphenidate) has shown the greatest scientific effects, but is complicated because the risk of adverse side effects and its potential for abuse. COGRAT, an evidence-based treatment combining cognitive therapy (CO) with graded activity training (GRAT), is found to be effective in treating fatigue in patients with acquired brain injury. However, therapist guided internet-based CBT (I-CBT) could offer a more accessible and cheaper alternative to this highly frequent face to face treatment. Moreover, I-CBT is found to be effective in a population with patients with psychiatric and chronic somatic disorders, including chronic fatigue syndrome. Recent studies suggests that I-CBT is effective for people with ABI as well. To obtain optimal benefit from both group delivered face to face therapy and e-health and to combine the available evidence of COGRAT and I-CBT in patients with ABI, we developed a blended e-health cognitive behavioral (group)intervention; e-COGRAT.

The goal of this intervention study is to evaluate the efficacy and feasibility of e-COGRAT to treat fatigue in people with ABI. The main questions it aims to answer are:

  • Is a blended eHealth cognitive behavioral (group)intervention (e-COGRAT) effective as a treatment for fatigue in people with ABI?
  • Is e-COGRAT the blended care variant of COGRAT, a cognitive behavioral group treatment for fatigue afer ABI, comparable to COGRAT in terms of efficacy?
  • Will participants of e-COGRAT improve significant on overall fatigue, emotional well-being and participation?
  • Will it be feasible for at least 80% of the participants to complete the intervention completely?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A single case experimental design (SCED) with AB and follow-up phases across participants will be used. Within this study design, every participant will receive the blended eHealth cognitive behavioral (group)intervention (e-COGRAT). Patients who have given consent to participate in the study will be assigned to a treatment group by random assignment. Each group consists of 4 participants. Due to the group-based intervention all participants of each group will start simultaneously and immediately after baseline phase (2 weeks) with the 12-week intervention phase. Start dates will be predetermined based on the running dates of each group. The follow-up phase, immediately following after intervention phase, will take 24 weeks. The total duration of the study is 37 weeks.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • An ABI diagnosis (stroke and traumatic brain injury) in the chronic phase (≥6 months after injury)
  • Complaints of severe fatigue (Checklist Individual Strength - subscale Fatigue score ≥ 40)
  • Full comprehension of Dutch language
  • Being cognitive capable of using the internet and having regular internet access.

Exclusion Criteria:

  • Having severe cognitive deficits (Behavioural Assessment of the Dysexecutive Syndrome (BADS) < borderline)
  • Having major untreated or unstable medical or psychiatric comorbidities (eg, epilepsy, psychosis)
  • Patients with (complaints of) depression are excluded if the depression subscale of the Hospital Anxiety and Depression Scale (HADS) is > 10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily fatigue
Time Frame: 1 year (daily in baseline and intervention phase and daily in the last week of follow-up)
Primary outcome is the change in severity of fatigue complaints on a daily visual analogue scale (VAS) ("How would you rate your fatigue today?") which will be registered by text messages. Participants can indicate the severity of the experienced fatigue by given themselves a grade between 0 - 4. 0: "I'm not tired"; 1: "I'm a little bit tired"; 2: "tired"; 3: "pretty tired"; "; 4: "seriously tired". These grades will also be used in the intervention.
1 year (daily in baseline and intervention phase and daily in the last week of follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue after ABI
Time Frame: 1 year (once in baseline, treatment and follow-up)
Fatigue after ABI will be assessed with the Dutch Multifactor Fatigue Scale (DMFS). The DMFS measures 5 aspects of fatigue regarding the four weeks preceding the assessment: Impact of fatigue, Mental fatigue, Signs and Direct consequences of fatigue, Physical fatigue and Coping with fatigue. The DMFS contains 38 items. Questions are answered on a 5-point Likert scale. Subscales of the DMFS showed sufficient to good reliability (Cronbach's alpha = 0.70 to 0.91), good convergent validity with an existing fatigue scale, and good divergent validity with measures of mood and self-esteem.
1 year (once in baseline, treatment and follow-up)
Fatigue in the general population
Time Frame: 1 year (once in baseline, treatment and follow-up)
Fatigue in the general population will be assessed with the Checklist Individual Strength - subscale Fatigue (CIS-f). The CIS-f contains 8 questions on fatigue severity regarding the two weeks preceding the assessment. The CIS-f has good reliability and is sensitive to change. Questions are answered on a 7-point Likert scale (1-7, higher scores represent higher fatigue).
1 year (once in baseline, treatment and follow-up)
Emotional distress
Time Frame: 1 year (once in baseline, treatment and follow-up)
Depression and anxiety symptoms of the last week will be assessed with the Dutch version of the 14-item Hospital Anxiety and Depression Scale (HADS). The reliability of the HADS is good (Cronbach's Alpha = 0.71 to 0.90) as is the test-retest reliability (0.86-0.90) (Spinhoven et al., 1997). Questions are answered on a 4-point Likert scale (0-3): 7 items on the depression subscale (HADS-D) and 7 items of the anxiety subscale (HADS-A). Subscale sumscores are categorized as normal (0-7), mild (8-10), moderate (11-14) or severe (15-21).
1 year (once in baseline, treatment and follow-up)
Level of participation
Time Frame: 1 year (once in baseline, treatment and follow-up)
The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) is a questionnaire to rate objective and subjective participation after rehabilitation. Internal consistency is satisfactory (Cronbach's Alpha = 0.70-0.91).
1 year (once in baseline, treatment and follow-up)
Feasibility of the overall online intervention
Time Frame: 1 year (once in treatment and follow-up)
Feasibility will be assessed with structured interviews about overall usability, experienced benefits and difficulties and level of involvement. These interviews, for both participants and therapists, will take place posttreatment and after follow up.
1 year (once in treatment and follow-up)
Feasibility of each specific online session
Time Frame: 1 year (weekly during treatment and after follow-up)
After each online session both patients and therapists fill in a questionnaire with questions about their experiences with the specific session concerning usability, content, lay out, potential technical difficulties and other assorted comments.
1 year (weekly during treatment and after follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Leiden

Collaborators

Heliomare Revalidatie

Investigators

  • Study Chair: Aglaia M. Zedlitz, Dr., Leiden University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • e-COGRAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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