NCT04376723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

September 27, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

March 19, 2020

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Kessler 10

    10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.

    Through study completion, an average of 18 weeks

  • Cognitive Emotion Regulation Questionnaire-Short

    18 item self-report process measure of cognitive strategies to regulate emotions with five response categories (almost never, rarely, occasionally, frequently, almost always). This measure has nine subscales, with two items each (self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophising, other-blame). Scores per subscale range from 2 to 10; higher scores indicate greater use of specific cognitive strategies, some of which are favourable and others indicate negative thinking styles.

    Through study completion, an average of 18 weeks

Secondary Outcomes (2)

  • Warwick-Edinburgh Mental Wellbeing Scale

    Through study completion, an average of 18 weeks

  • CompACT-8

    Through study completion, an average of 18 weeks

Other Outcomes (2)

  • Personal Questionnaire

    Through study completion, an average of 18 weeks

  • Change Interview

    Up to 18 weeks

Study Arms (1)

Assisted self-guidance

EXPERIMENTAL

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.

Other: Mental Health Mobile Application

Interventions

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

Assisted self-guidance

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lincolshire Partnership NHS Foundation Trust

Lincoln, Lincolnshire, LN5 7RZ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 28546138BACKGROUND
  • 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.

Study Officials

  • David Dawson, DClinPsy

    University of Lincoln

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

May 6, 2020

Study Start

September 1, 2020

Primary Completion

August 20, 2021

Study Completion

September 14, 2021

Last Updated

September 27, 2021

Record last verified: 2021-04

Locations