Brief use of the Unmind digital mental health platform to help tackle depressive symptoms

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: This study will evaluate three brief digital interventions for low mood and depressive symptoms on the Unmind digital mental health and wellbeing platform. Participants will be randomised 1:1:1:1 to an intervention arm or a waitlist control arm. Randomisation will be implemented by the Qualtrics "randomizer" feature (https://www.qualtrics.com), which uses block randomisation to ensure balanced groups. Unmind is a digital platform designed to help working adults measure, manage and improve their mental health and wellbeing. This study will evaluate three brief interventions (Series) on the Unmind platform intended to help users tackle low mood and depressive symptoms. Unmind can be accessed via the web on desktop, tablet or mobile devices. The mobile app can be downloaded from the Apple App or Google Play stores. Content on the platform is wide‐ranging and includes a mood tracker (the ‘Check‐In’), an internally developed and validated measure of mental health and wellbeing (the ‘Unmind Index’), a catalogue of standalone exercises designed to be used ad hoc (‘Tools’), and more formal programmes designed to address specific areas of mental health and wellbeing, known as ‘Series’. Unmind content is created by clinicians and academics with expertise in adult mental health, and is rooted in evidence‐based practices including behavioural activation (BA) (Jacobson et al., 2001), cognitive behavioral therapy (CBT); (Beck, 1976), acceptance and commitment therapy (ACT) (Hayes et al., 1999), mindfulness meditation (Kabat‐Zinn, 2004) and psychoeducation. The Series assessed in this study are based on principles of BA, CBT and ACT for depression, and contain six to eight 10‐20 minute sessions designed to be completed over a period of up to 3 weeks. CONDITION: Low mood and depressive symptoms ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; Collected using a combination of objective adherence data obtained from the Unmind platform and self‐report questionnaire data collected at the post intervention and follow up study assessments:; 1. Feasibility: recruitment rate, intervention uptake (participants initiating their randomised brief intervention within the intervention period), and retention (study dropout); 2. Acceptability: intervention adherence (intervention completion rate, defined as the completion of all sessions of the allocated Series within the intervention period), activity adherence (the self‐reported completion rate for all additional Series activities to be completed between sessions), participant satisfaction, reasons for non adherence, and qualitative feedback; 3. Engagement: intervention sessions completed, self‐reported additional (between session) activity completion, and three questions adapted from Sections A and B of the Mobile App Rating Scale (MARS); 4. Transferability: one question adapted from Section E of the MARS; 5. Relevance: one question assessing subjective relevance of the brief intervention(s); 6. Negative effects: one question assessing bad effects, one question asking about lasting bad effects, and the proportion of participants that deteriorate from baseline to post intervention and follow up according to the PHQ‐8 for each intervention arm and relative to the no‐intervention control. Deterioration will be defined as an increase of >5 in PHQ‐8 score from baseline; SECONDARY OUTCOME: ; 1. Mood measured using the Patient Health Questionnaire at baseline, post‐intervention (3 weeks) and follow up (7 weeks).; 2. Anxiety measured using the Generalised Anxiety Disorder Scale at baseline, 3 weeks and 7 weeks; 3. Mental health and wellbeing measured using the Unmind Index at baseline, 3 weeks and 7 weeks; 4. Mental wellbeing measured using the Short Warwick‐Edinburgh Mental Wellbeing Scale at baseline, 3 weeks and 7 weeks; 5. Health‐related work productivity loss measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline, 3 weeks and 7 weeks; INCLUSION CRITERIA: 1. Aged 18+ years 2. Currently living in the UK 3. Fluent in English 4. Currently in full‐ or part‐time employment 5. Internet access (desktop or mobile device) 6. Active account on the Prolific study recruitment website (https://www.prolific.co/) 7. Currently experiencing subthreshold or mild to moderate low mood and depressive symptoms according to the Patient Health Questionnaire 8 item version (PHQ‐8; Kroenke et al., 2009), with a score between 5 and 14 at baseline 8. A self‐reported interest in using a brief digital intervention designed to help tackle low mood and depressive symptoms 9. Willingness to download the Unmind app or engage with the platform via a desktop device and create an account using a personal email address. 10. Willingness to be randomised
Epistemonikos ID: 31c98fefa1c6f16db2f74189198f0809b9871f9c
First added on: Aug 25, 2024