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A Blended Psychological Intervention for Depression After Acquired Brain Injury

Primary Purpose

Acquired Brain Injury, Stroke, Head Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

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

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Blended psychological intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    March 27, 2023
    Sponsor
    King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05788146
    Brief Title
    A Blended Psychological Intervention for Depression After Acquired Brain Injury
    Official Title
    A Blended Psychological Intervention for Depression After Acquired Brain Injury Using a Novel Smartphone-based App: a Feasibility and Acceptability Investigation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acquired Brain Injury, Stroke, Head Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blended psychological intervention
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Cognitive Behavioural Therapy
    Intervention Description
    A psychological intervention used to target depression
    Primary Outcome Measure Information:
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Generalised Anxiety Disorder Assessment (GAD-7)
    Description
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Grace Lakey
    Phone
    07596892154
    Email
    grace.lakey@kcl.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Blended Psychological Intervention for Depression After Acquired Brain Injury

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