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

Feasibility and preliminary efficacy of digital interventions for depressive symptoms in working adults: a multi-arm randomised pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13067492

Enrollment

405

Registered

2021-09-21

Start date

2021-09-23

Completion date

Unknown

Last updated

2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low mood and depressive symptoms Mental and Behavioural Disorders

Interventions

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 a

(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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Self reported diagnosis of bipolar disorder, schizophrenia or other psychotic spectrum disorder, alcohol or substance use disorder, or neurocognitive disorder 2. Undergoing psychological therapy for low mood or depression with a health professional at screening 3. Previous use of the Unmind platform 4. Current or previous participation in another Unmind study 5. Participants will also be informed that they should not take part in this study should they be unwilling to commit to participation in the study period (3 weeks) and follow up (4 weeks)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Contacts

Public ContactRachael Taylor

rachael.taylor@unmind.com+44 (0)7814522979

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026