An Online Self-help Intervention for Prevention of Depression in Primary Care

NCT04139785 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2019-11-13

No results posted yet for this study

Summary

Depression is a common condition and is the leading cause of disability worldwide. Preventing or delaying the onset of depression is an important way to reduce the burden of depression. Some research suggests online methods may be effective in preventing depression, but to date, few studies have looked at the application of these methods in the UK.

This study aims to assess the effects of an online self-help intervention (Moodbuster) on preventing depression in a primary care population, who are experiencing mild-moderate symptoms of depression, but do not meet the threshold for diagnosis.

A randomised control design with a six-month and nine-month follow up will be used to compare Moodbuster to a wait-listed control group. Then, a qualitative process evaluation will be used to understand the barriers and facilitators of implementing the intervention.

Eligible participants in Greater Manchester (individuals with mild to moderate symptoms of depression, who do not have a diagnosis of major depressive disorder and have access to the internet) will take part in a 6-week online self-help programme, accompanied by three telephone calls with a trained researcher to support them in their use of the programme. Researchers will follow-up with participants six and nine months after starting the programme to measure depression, anxiety, quality of life, and use of services. The process evaluation will involve qualitative interviews with participants and focus groups with practitioners who referred individuals to the study.

This study will assess the effects of Moodbuster on preventing depression and barriers and facilitators of implementing such an intervention in a UK primary care population. It is hypothesised that the intervention group will display reduced depression symptoms and incidence, reduced service use, and improved quality of life, and the intervention will be acceptable to a UK primary care population.

Conditions

Interventions

OTHER

Moodbuster

Moodbuster intervention comprises three elements: (1) a web-based interface providing the patients access to CBT therapies, (2) a web-based portal for the trial co-ordinator and researchers, where they can view participation, amend modules and send login codes, (3) a mobile phone component which enables daily EMA monitoring of mood state, cognitions, activities, social interaction, and sleep. The mobile application will be used to capture EMA data.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER
  • VU University of Amsterdam

    collaborator OTHER
  • University of Manchester

    collaborator OTHER
  • Mental Health Foundation, London

    lead OTHER

Principal Investigators

  • Kathryn M Abel, PhD · University of Manchester

  • Antonis Kousoulis, MD · Mental Health Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2020-11-30
Completion
2021-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT04139785 on ClinicalTrials.gov