Acquired Brain InjuryNCT05788146
A Blended Psychological Intervention for Depression After Acquired Brain Injury
A study testing Cognitive Behavioural Therapy in people with Acquired Brain Injury and Stroke, run by King's College London.
Trial summary
1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Stroke, Head Injury
- What is being tested?
- Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of an acquired brain injury resulting from either stroke (cerebral infarction, intracerebral haemorrhage, or an uncertain pathology) or TBI (closed brain injury, contusions/coup-contrecoup, diffuse axonal injury, intracranial hematomas). If there is a diagnosis of TBI, this will be classified within the moderate range, as determined by clinical information available, as well as self-reported information regarding level of hospital input gained within the screening phase.
- ABI occurring within the last 5 years.
- 18 years old or over.
- Fluency in English adequate enough to engage with the blended intervention.
- A score equal or greater than 5, but no more than 14 on the Brief Patient Health Questionnaire (PHQ-9), indicating mild-moderate levels of depression.
- Have access to an iOS or Android app-compatible smartphone for the duration of the study.
Who cannot join
- Diagnosed with a mild or severe TBI, as determined by clinical information available as well as self-reported information regarding level of hospital input gained within the screening phase.
- Inability to consent to take part in the research study.
- Unable to undergo a verbal interview due to impairment of comprehension.
- A visual or auditory problem that cannot be corrected and would seriously interfere with participation in the research study.
- Currently in receipt of other individual psychological therapy
- Currently enrolled in another clinical trial or research study
Show all 10Show fewer
- Have a reading ability or command of English language inadequate for engaging with the blended intervention.
- Diagnosed with a neurodegenerative disorder, e.g. dementia, Parkinson's disease etc.
- Active suicidal ideation (as indicated by a score ≥ 2 on item 9 of the PHQ.
- A score greater than or equal to 20 on the PHQ-9 which indicates a severe level of depression
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Blended Psychological Intervention for Depression After Acquired Brain Injury Using a Novel Smartphone-based App: a Feasibility and Acceptability Investigation
1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. There is growing interest into increasing access to CBT through mHealth technology, including mobile applications.
Objective: Phase 1 of the study aims to investigate whether a blended psychological intervention, using a novel smartphone-based application alongside individual therapy sessions is acceptable and feasible for targeting depression after ABI. Phase 2 of the study aims to use qualitative interviews to better understand the participants' experiences of using the mobile app as part of the intervention.
Read more
Methodology: The researchers aim to recruit 20 individuals with ABI, who are experiencing mild-moderate symptoms of depression. Participants will complete outcome measures and cognitive tasks at the beginning of the study. Participants will then receive a six-week blended psychological intervention; engaging the CBT-based mobile app alongside weekly, 30-minute video or telephone sessions for therapeutic and technology support. Participants will then be asked to complete the same outcome measures as completed at the beginning of the study. Participants will then be invited to take part in a 30-minute interview about their experience of using the mobile app as part of the intervention.
Data Analysis: Change scores will be calculated from the data collected as part of phase 1 of the study, to investigate initial efficacy. Recruitment and dropout rates will help determine the feasibility of the blended intervention. In the 2nd phase, qualitative data will be analysed following Ritchie and Lewis (2003)'s Framework Analysis.
Findings: Results from this study will help increase understanding into the acceptability and feasibility of using mHealth technology for treating depression following ABI. If effective, it could help to increase access to psychological interventions for individuals living with ABI. We hope to publish findings in a peer reviewed journal.
- Conditions
- Acquired Brain Injury, Stroke, Head Injury
- Being tested
- Cognitive Behavioural Therapy
- Medical subject headings
- Brain Injuries, Stroke, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyOther
A psychological intervention used to target depression
| Study group | Role | What they receive |
|---|---|---|
| Blended psychological intervention | Experimental | Not described Receives: Other: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
This is a validated self report measure for symptoms of low mood. Scores range from 0-27, with higher scores suggestive of increased levels of depression. The change in score within each participant between baseline and end of study will be measured.
Measured: 8 weeks
Secondary outcomes (1)
Generalised Anxiety Disorder Assessment (GAD-7)
This is a validated self report measure for symptoms of anxiety. Scores range from 0-21, with higher scores suggestive of increased levels of anxiety. The change in score within each participant between baseline and end of study will be measured.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788146
- Sponsor's protocol ID
- KCLGL
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blended Psychological Intervention for Depression After Acquired Brain Injury Using a Novel Smartphone-based App: a Feasibility and Acceptability Investigation
- ClinicalTrials.gov ID
- NCT05788146
- Acronym / sponsor ID
- KCLGL
- Conditions
- Acquired Brain Injury, Stroke, Head Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. There is growing interest into increasing access to CBT through mHealth technology, including mobile applications.
Objective: Phase 1 of the study aims to investigate whether a blended psychological intervention, using a novel smartphone-based application alongside individual therapy sessions is acceptable and feasible for targeting depression after ABI. Phase 2 of the study aims to use qualitative interviews to better understand the participants' experiences of using the mobile app as part of the intervention.
Methodology: The researchers aim to recruit 20 individuals with ABI, who are experiencing mild-moderate symptoms of depression. Participants will complete outcome measures and cognitive tasks at the beginning of the study. Participants will then receive a six-week blended psychological intervention; engaging the CBT-based mobile app alongside weekly, 30-minute video or telephone sessions for therapeutic and technology support. Participants will then be asked to complete the same outcome measures as completed at the beginning of the study. Participants will then be invited to take part in a 30-minute interview about their experience of using the mobile app as part of the intervention.
Data Analysis: Change scores will be calculated from the data collected as part of phase 1 of the study, to investigate initial efficacy. Recruitment and dropout rates will help determine the feasibility of the blended intervention. In the 2nd phase, qualitative data will be analysed following Ritchie and Lewis (2003)'s Framework Analysis.
Findings: Results from this study will help increase understanding into the acceptability and feasibility of using mHealth technology for treating depression following ABI. If effective, it could help to increase access to psychological interventions for individuals living with ABI. We hope to publish findings in a peer reviewed journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blended psychological intervention | Experimental | Other: Cognitive Behavioural Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of an acquired brain injury resulting from either stroke (cerebral infarction, intracerebral haemorrhage, or an uncertain pathology) or TBI (closed brain injury, contusions/coup-contrecoup, diffuse axonal injury, intracranial hematomas). If there is a diagnosis of TBI, this will be classified within the moderate range, as determined by clinical information available, as well as self-reported information regarding level of hospital input gained within the screening phase.
Key exclusion criteria (10 listed)
- Diagnosed with a mild or severe TBI, as determined by clinical information available as well as self-reported information regarding level of hospital input gained within the screening phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyA psychological intervention used to target depression | Other | Blended psychological intervention |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 8 weeks
This is a validated self report measure for symptoms of low mood. Scores range from 0-27, with higher scores suggestive of increased levels of depression. The change in score within each participant between baseline and end of study will be measured.
1 secondary outcome
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Acquired Brain Injury and Stroke, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Lakey (07596892154, grace.lakey@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.