Using cognitive-behavioral therapy to manage tiredness after a brain injury

Cognitive behavioural therapy for the management of fatigue after acquired brain injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18810622

Enrollment

Registered

2023-12-11

Start date

2023-11-20

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of fatigue after acquired brain injury Nervous System Diseases

Interventions

Cognitive behavioural therapy will be provided to all participants of the study. As this is a single case experimental design study, all participants will receive the same intervention which is cogn

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. An adult 2. Have an acquired brain injury 3. Experience fatigue 4. Have not experienced CBT before 5. Don’t have any significant problems with communication or thinking skills

Exclusion criteria

Exclusion criteria: 1. Not able to engage with talking therapies 2. Had CBT in the past 3. Do not have a brain injury 4. Participants are involved with other psychological therapies

Design outcomes

Secondary

Measure	Time frame
1. Overall health will be measured with the SF-36 questionnaire, (Lins & Carvalho, 2016) at all baseline assessments (4 in total). 2. Depression will be measured with the Patient Health Questionnaire-9, (Sun et al., 2019) at all baseline assessments (4 in total). 3. Anxiety will be measured with the General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) at all baseline assessments (4 in total). 4. Therapeutic alliance will be measured with the Working Alliance Inventory, (Tatman & Love, 2010) in three baseline assessments (3 in total, not in the very first baseline assessment).	—

Measure

Time frame

1. Overall health will be measured with the SF-36 questionnaire, (Lins & Carvalho, 2016) at all baseline assessments (4 in total). 2. Depression will be measured with the Patient Health Questionnaire-9, (Sun et al., 2019) at all baseline assessments (4 in total). 3. Anxiety will be measured with the General Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) at all baseline assessments (4 in total). 4. Therapeutic alliance will be measured with the Working Alliance Inventory, (Tatman & Love, 2010) in three baseline assessments (3 in total, not in the very first baseline assessment).

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Primary

Measure	Time frame
1. Fatigue will be measured by completing daily fatigue ratings (Salman et al., 2013). Participants will be asked to use a visual analogue scale (from 0 meaning not tired to 10 meaning extremely tired) on a daily basis throughout the intervention. 2. Fatigue will be measured using the Modified Fatigue Impact Scale (MFIS), (Ghajarzadeh et al., 2012) at all baseline assessments (4 in total). 3. Fatigue will be measured using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), (Shahid et al., 2011) at all baseline assessments (4 in total).	—

Measure

Time frame

1. Fatigue will be measured by completing daily fatigue ratings (Salman et al., 2013). Participants will be asked to use a visual analogue scale (from 0 meaning not tired to 10 meaning extremely tired) on a daily basis throughout the intervention. 2. Fatigue will be measured using the Modified Fatigue Impact Scale (MFIS), (Ghajarzadeh et al., 2012) at all baseline assessments (4 in total). 3. Fatigue will be measured using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), (Shahid et al., 2011) at all baseline assessments (4 in total).

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Countries

England, United Kingdom

Contacts

Public ContactAlexandros Zouloumis

az4n21@soton.ac.uk+44 (0)23 8059 5000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026