Clinical trial NCT05863897: e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
Official title: e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acquired Brain Injury
Fatigue
Keywords: Intervention
eHealth
Rehabilitation
Feasibility
Lead sponsor: Universiteit Leiden
Sponsor class: OTHER
Collaborators: name: Heliomare Revalidatie
First posted: 2023-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-case experimental design with AB and follow-up phases across participants.
Primary purpose: TREATMENT

Brief summary: 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily fatigue
timeFrame: 1 year (daily in baseline and intervention phase and daily in the last week of follow-up)
Secondary outcomes:
measure: Fatigue after ABI
timeFrame: 1 year (once in baseline, treatment and follow-up)
measure: Fatigue in the general population
timeFrame: 1 year (once in baseline, treatment and follow-up)
measure: Emotional distress
timeFrame: 1 year (once in baseline, treatment and follow-up)
measure: Level of participation
timeFrame: 1 year (once in baseline, treatment and follow-up)
measure: Feasibility of the overall online intervention
timeFrame: 1 year (once in treatment and follow-up)
measure: Feasibility of each specific online session
timeFrame: 1 year (weekly during treatment and after follow-up)
Other outcomes:
Locations:
city: Wijk aan Zee
country: Netherlands
facility: Heliomare
state: Noord Holland
Study officials:
affiliation: Leiden University
name: Aglaia M. Zedlitz, Dr.
role: STUDY_CHAIR
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