Clinical trial NCT04376723: Mental Health Apps for Mild Psychological Distress Amongst Adolescents
Official title: Mental Health Mobile Application Self-Help for Adolescents Exhibiting Mild Psychological Distress: A Single Case Experimental Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: Lincolnshire Partnership NHS Foundation Trust
First posted: 2020-05-06
Enrollment: 5
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates mental health mobile apps, to understand their efficacy in reducing mild levels of psychological distress amongst adolescents. All participants will be provided with an app which is already available in the public domain, and will be asked to use the app for guided self-help. Half of participants will receive a weekly telephone call, whilst the other half will not.

Detailed description: The subscription version of the app "Sanvello" has several self-help exercises based on Cognitive Behavioural Therapy (to identify and challenge their thinking styles) and Mindfulness practices (to connect them with the present moment). Participants will be asked to complete these exercises on a daily basis for five weeks.

Telephone calls will be provided weekly to half of participants to provide information about the app, or a rationale for its use. This phone call will not serve to provide any extra intervention or therapy to the participants.

Eligibility criteria: Inclusion Criteria:

* Be aged 13-18 years, as the proposed research aims to investigate "adolescents".
* Have capacity to give informed consent, to ensure the integrity of participants and prioritise their best interests.
* Be awaiting input from the Healthy Minds Lincolnshire service, given the method of recruitment, prospective participants will be on a waiting list for the named service.
* Be experiencing psychological distress, to fulfil the research aims.

Exclusion Criteria:

* Accessing crisis support, to ensure that necessary support is not being withheld due to research participation.
* They do not speak and understand English, to ensure the app-intervention and measures (which are in English) may be completed, and so interviews may be conducted without a translator.
* They are unable to access or use a smart device, the internet, and the app, as they must be able to access a device daily and be technology literate to utilise the intervention.
* For 13-15 year olds: parental consent must also be provided to take part. If this is not provided, they will be unable to participate. Those aged 16-18 years can provide consent for themselves.

Primary outcomes:
measure: Kessler 10
timeFrame: Through study completion, an average of 18 weeks
measure: Cognitive Emotion Regulation Questionnaire-Short
timeFrame: Through study completion, an average of 18 weeks
Secondary outcomes:
measure: Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Through study completion, an average of 18 weeks
measure: CompACT-8
timeFrame: Through study completion, an average of 18 weeks
Other outcomes:
measure: Personal Questionnaire
timeFrame: Through study completion, an average of 18 weeks
measure: Change Interview
timeFrame: Up to 18 weeks
Locations:
city: Lincoln
country: United Kingdom
facility: Lincolshire Partnership NHS Foundation Trust
state: Lincolnshire
Study officials:
affiliation: University of Lincoln
name: David Dawson, DClinPsy
role: STUDY_CHAIR
References:
citation: Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332.