None listed
Conditions
Brief summary
This is an online primary randomised control trial and parallel engagement and acceptability trial to evaluate the efficacy and acceptability of an emotional wellbeing app for adolescents with mild-to-moderate symptoms of depression and/or anxiety. The primary aim is to determine whether a smartphone app for emotional wellbeing (“Quest - Te Whitianga”) is effective at reducing symptoms of depression and/or anxiety in adolescents who present with these symptoms to health, counselling or youth services. Secondary aims include estimating the acceptability of and level of engagement with the “Quest - Te Whitianga” app for young people, regardless of their level of symptoms. Participant referral is designed to maximise recruitment opportunities, particularly for Maori and Pasifika young peoples. Participants will be eligible if they are 11-16 years of age; have been approached or identified by a healthcare provider ("referrer") as needing some support for their emotional wellbeing; and have access to a smart phone, tablet or Chromebook, All study procedures will be carried out online to reduce participant burden. Enrolment process will be the same for all volunteers. All participants will provide electronic informed consent and complete baseline assessments, including eligibility screening for the primary RCT trial. Participants will be included in the primary RCT (n=100) if they report mild to moderate symptoms at baseline. Participants excluded from the primary RCT trial because they will report no or minimal symptoms of depression and/or anxiety at baseline will enter an engagement and acceptability open trial. Those who report more severe symptoms of depression and/or anxiety, or who endorse a response of 2 or 3 on question 9 of the PHQ-A (“Thoughts that you would be better off dead, or of hurting yourself in some way”) at baseline will be referred for additional support. These individuals will also be offered the use of the “Quest - Te Whitianga” and will enter the engagement and acceptability open trial. Self-reported outcome data will be collected electronically at 4-6 weeks (“post intervention”) and 8-10 weeks (“follow-up”) from baseline. Passive data collection (duration and pattern of use as well as completion of modules and activities in the app) will be used in the intervention period to report on app usage for all participants (RCT and open trial). The primary outcome measure for efficacy is the change in the composite PHQ-GAD-7 measure (PHQ-ADS) immediately post-treatment compared with baseline. The primary outcome measure for acceptability includes brief app rating scale designed for our web platform.
Interventions
The intervention ("Quest - Te Whitianga") is an app available to study participants for download on their personal Android or iOS smart phone, or Chromebook, for self-directed use for the duration of the trial. For this evaluation trial, the treatment period will be approximately four weeks.
The app has been co-designed with Maori and Pasifika young people as part of the HABITs research group. The app consists of six modules, most of which contain at least three ‘levels’, which encourages the u
The intervention ("Quest - Te Whitianga") is an app available to study participants for download on their personal Android or iOS smart phone, or Chromebook, for self-directed use for the duration of the trial. For this evaluation trial, the treatment period will be approximately four weeks. The app has been co-designed with Maori and Pasifika young people as part of the HABITs research group. The app consists of six modules, most of which contain at least three ‘levels’, which encourages the user to practise each skill at an increasing level of difficulty. The app is highly visual and requires minimum reading. The content is based on evidence-based strategies derived from Cognitive Behavioural Therapy, Interpersonal Therapy (IPT) and positive psychology approaches. The app consists of six modules, most of which contain at least three ‘levels’, which encourages the user to practise each skill at an increasing level of difficulty. Each module contains interactive activities (e.g. relaxation activity, entries in a gratitude journal, selecting activities to try out, interactive conversations). Module levels generally take less than 5 minutes to complete. The app is highly visual and requires minimum reading. The content is based on evidence-based strategies derived from Cognitive Behavioural Therapy, Interpersonal Therapy (IPT) and positive psychology approaches. The six modules cover the following core concepts: 1. Relaxation and mindfulness: brief slow and controlled breathing exercises 2. Structured problem solving: STEPS (Say what the problem is, Think of solutions, Examine each one, Pick one, See what happens) 3. Activity scheduling: an activity picker exercise designed to motivate the user to do fun, active and new activities to lift mood 4. Gratitude Journal: each time a user logs into the app s/he is asked to name three things they are grateful that day. 5. Interpersonal skills; Communication, assertiveness and staying in control of strong emotions 6. How thoughts influence emotions and how to deal with negative thoughts through ‘accept, distract, reframe’ methods. In the first instance, participants are introduced to the first level of each island (activity) sequentially (in the order: gratitude journal, relaxation, activity scheduling, thoughts and emotions, problem solving, interpersonal skills). Thereafter, participants are able to progress and continue at their discretion. Adherence to the intervention will be assessed using app usage metrics including duration and pattern of use as well as completion of modules and activities in the app. The app is linked through secure individual user accounts to the HABITs IT platform. The "Quest - Te Whitianga" app will be used in an open-label fashion by participants excluded from the RCT trial, and these participants will contribute data to the 'Acceptability' primary outcome.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
11 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for inclusion if: •They are aged 11-16 years of age (on the day of consent); •They have approached, or been identified by, a school guidance counsellor, school nurse or primary healthcare provider as needing some support for their emotional wellbeing (‘feeling stressed, down, worried’ or having some symptoms of depression and/or anxiety); •They have access to a smart phone, tablet or Chromebook at home (Android, iOS or Chromebook);
Exclusion criteria
Participants will be ineligible for this study if: •They are unable to sufficiently understand the nature of study involvement or to provide online informed consent; •They have, in the judgement of the referring health practitioner, an acute risk of self-harm requiring urgent intervention (i.e. suicidal ideation with a current plan and intent to enact this plan) or a level of emotional distress that warrants face-to face counselling.
Outcome results
None listed