Exploratory pilot trial of Help4Mood

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
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. CONDITION: Depression ; Mental and Behavioural Disorders ; Depressive episode, unspecified PRIMARY OUTCOME: To evaluate the feasibility and acceptability of a randomised controlled trial of Help4Mood for patients with major depressive disorder in primary care. 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 SECONDARY OUTCOME: 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
Epistemonikos ID: 2e3fb5eb1c5e976df88256b04e53afa54867f1a1
First added on: Aug 22, 2024