Depression Mental and Behavioural Disorders Depressive episode, unspecified
Conditions
Interventions
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 desi
Sponsors
The University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility and acceptability of a randomised controlled trial of Help4Mood for patients with major depressive disorder in primary care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed