Mental Health Apps for Mild Psychological Distress Amongst Adolescents

NCT ID: NCT04376723

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Assisted self-guidance

Participants will be asked to use the app for five weeks and will be contacted via telephone once a week by a researcher to provide a rationale for using the app, or to offer any information about the app itself. This will not be used to provide therapeutic intervention.

Group Type EXPERIMENTAL

Mental Health Mobile Application

Intervention Type OTHER

Mobile phones will not be provided to participants, but app subscriptions will be provided.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mental Health Mobile Application

Mobile phones will not be provided to participants, but app subscriptions will be provided.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lincolnshire Partnership NHS Foundation Trust

UNKNOWN

Sponsor Role collaborator

University of Lincoln

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Dawson, DClinPsy

Role: STUDY_CHAIR

University of Lincoln

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lincolshire Partnership NHS Foundation Trust

Lincoln, Lincolnshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28546138 (View on PubMed)

Badesha K, Wilde S, Dawson DL. Mental health mobile application self-help for adolescents exhibiting psychological distress: A single case experimental design. Psychol Psychother. 2023 Mar;96(1):223-248. doi: 10.1111/papt.12436. Epub 2022 Nov 7.

Reference Type DERIVED
PMID: 36345016 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-help App and Wellbeing
NCT04911803 COMPLETED NA