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A Blended Psychological Intervention for Depression After Acquired Brain Injury

NCT05788146 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-28

No results posted yet for this study

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.

Conditions

  • Acquired Brain Injury
  • Stroke
  • Head Injury

Interventions

OTHER

Cognitive Behavioural Therapy

A psychological intervention used to target depression

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-01-01
Completion
2024-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788146 on ClinicalTrials.gov