Plain English Summary
Background and study aims
The aim of the Help4Mood project is to develop an interactive computer based system for upporting the treatment of people with major depressive disorder in the community. Help4Mood is designed to facilitate recovery from depression through monitoring activity, mood and thoughts, and by using this information to help patients and their clinicians work together. The current system of Help4mood has already been tested via focus groups and case studies with non-patients as well as with patients who have experienced depression (but are recovered from it). The aim of this initial study is to test the feasibility of the online Help4Mood system with a small number of people who currently have depression and to help design a larger study.
Who can participate?
Participants aged up to 30 and treated for depression.
What does the study involve?
Participants will be randomly allocated to one of two groups: a treatment as usual group and a treatment as usual plus Help4Mood intervention.
Participants allocated to the treatment as usual plus the Help4Mood intervention will be asked to use Help4Mood system every day for 4 weeks (for example to log details about their mood, thoughts, quality of sleep etc).
What are the possible benefits and risks of participating?
Nor provided at time of registration
Where is the study run from?
A total of 18 participants in Scotland will be recruited.
When is the study starting and how long is it expected to run for?
November 2013 to March 2014.
Who is funding the study?
European Commission
Who is the main contact?
Prof Brian McKinstry
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0
Study information
Scientific title
Exploratory pilot trial of Help4Mood: randomised controlled trial
Acronym
Help4Mood T6.8
Study hypothesis
The aim of this study is to evaluate the feasibility and acceptability of a randomised controlled trial of Help4Mood for patients with major depressive disorder in primary care.
Ethics approval
South East Scotland Ethics Committee 01, 14/11/2013, REC reference: 13/SS/0207
Study design
Two centre feasibility study. Blocked randomization (1:1) for each site (e.g. GP practice) with variable sized blocks (2 or 4). Concealed allocation. The study is not blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression
Intervention
Help4Mood + Treatment as usual will be compared to Treatment as usual.
The duration of the intervention is 4 weeks.
The duration of the follow up is 1 day post intervention.
Help4Mood has been designed as an intervention to support clinical management of depression which has persisted after initial treatment, potentially while awaiting more specialised care. It aims to extend CBT-based guided self help by:
1. Providing a more interactive interface
2. Breaking CBT tasks into smaller daily chunks rather than longer workbook sessions
3. Adding additional data on physical activity, sleep and speech delivery (though not content)
4. Compiling data from interactions with the system into an easily readable and informative report for the patient and their usual clinicians
The Help4Mood System consists of a laptop or computer with some special software on it. The laptop and the data on it are completely secure. No one apart from the participant's doctor and the researcher on the study will be able to see any information about participants which is in it. Participants will be asked to use the Help4Mood system on the computer every day for 4 weeks. This involves doing the following activities:
1. Doing a mood check (daily)
2. Evaluating any negative and positive thoughts (daily)
3. Rate sleep quality (daily)
4. Wearing an activity monitor which can be worn on the wrist or the waist
5. To choose a rewarding activity (weekly) and report on whether they have done it (twice a week)
6. To do a relaxation exercise (twice a week)
7. To provide a speech sample of up to one minute in length (up to three times a week)
8. To do a depression questionnaire - PHQ-9 (once a week)
Participants will be asked to make an appointment to see their usual doctor where they can discuss the results from the Help4Mood system. The Help4Mood system will generate a one-page report that will be emailed to their doctor.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To evaluate the feasibility and acceptability of a randomised controlled trial of Help4Mood for patients with major depressive disorder in primary care.
Secondary outcome measures
To examine:
1. The demographic characteristics (age, sex, working and domestic status) of trial participants
2. The baseline depression characteristics (severity, duration of current episode, number of past episodes, past and current treatment) of these individuals
3. The acceptability, to clinicians and patients of the identification, recruitment, randomisation and related trial procedures
4. Adherence to the intervention and trial protocol among pilot study participants, specifically:
4.1. Proportion in the active arm who use the Help4Mood system regularly (daily)
4.2. Patterns of less frequent use / cessation among those in the active arm
4.3. Completion of baseline and short term follow up measures in both arms
5. Changes in the proposed outcome measures while this study will not be powered to show statistical significance, these data will be used to power a full trial
6. Subjective experiences and opinions of participants including:
6.1. Personal experience of using Help4Mood during the pilot study
6.2. Perceived effects of Help4Mood on thoughts or behaviour
6.3. Effect of using Help4Mood on relationship between patients and healthcare providers from the point of view of the patient
6.4. Suggestions for modification either of Help4Mood or study procedures
Overall trial start date
15/11/2013
Overall trial end date
28/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged up to 30 years old inclusive
2. Under the supervision of a clinician and being treated with antidepressant medication which has not been changed (dose or agent) in the four weeks prior to recruitment
3. Patients prescribed additional hypnotics or anxiolytics for symptom relief will also be eligible
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. A Beck Depression Inventory (BDI) II score indicative of severe depression (≥30)
2. Significant risk of self harm or suicide based on either clinical assessment or item 9 of BDI -II (excluded answers I would like to kill myself and I would kill myself if I had the chance)
3. Current or recent (last month) self-harm behaviour
4. Current or past bipolar disorder
5. Current or past psychotic disorder
6. Current panic disorder
7. Current substance abuse, organic brain syndrome or mental learning difficulty
8. Augmented antidepressant treatment (multiple antidepressants, concurrent antipsychotic drug or lithium)
9. Currently receiving psychological therapy (e.g. structured CBT, but not including general psychological supportive treatment)
Recruitment start date
15/11/2013
Recruitment end date
28/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Population Health Sciences
Edinburgh
EH8 9AG
United Kingdom
Sponsor information
Organisation
The University of Edinburgh (UK)
Sponsor details
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 6226
ray.french@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Commission (Belgium) Ref: 24765
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
01/09/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26453910