Mental Health Apps for Mild Psychological Distress Amongst Adolescents

September 20, 2021 updated by: University of Lincoln

Mental Health Mobile Application Self-Help for Adolescents Exhibiting Mild Psychological Distress: A Single Case Experimental Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lincolnshire
      • Lincoln, Lincolnshire, United Kingdom, LN5 7RZ
        • Lincolshire Partnership NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Mental Health Mobile Application
Mobile phones will not be provided to participants, but app subscriptions will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kessler 10
Time Frame: Through study completion, an average of 18 weeks
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
Time Frame: Through study completion, an average of 18 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Warwick-Edinburgh Mental Wellbeing Scale
Time Frame: Through study completion, an average of 18 weeks
14 item self-report measure of wellbeing with five response categories (none of the time, rarely, some of the time, often, all of the time). Scores range from 14 to 70; a higher score indicates better mental wellbeing and scores below a cut point of 40 indicate low wellbeing.
Through study completion, an average of 18 weeks
CompACT-8
Time Frame: Through study completion, an average of 18 weeks
8 item self-report measure of psychological flexibility with six response categories (strongly disagree, moderately disagree, slightly disagree, neither agree nor disagree, slightly agree, moderately agree, strongly agree). Total scores range from 0 to 48, with higher scores indicating greater psychological flexibility. This measure has three subscales: openness to experience (range of scores: 0 to 18), behavioural awareness (range of scores: 0 to 12), and valued action (range of scores: 0 to 18); as with the overall score, higher subscale scores indicate favourable outcomes.
Through study completion, an average of 18 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal Questionnaire
Time Frame: Through study completion, an average of 18 weeks
Participant-generated goals, established by asking each participant which difficulties the individual would like to work on. Ten items are established with each participant (e.g. with a focus on symptoms, mood, specific activities, relationships, or self-esteem). Each of the ten items is rated according to seven response categories (this has bothered me: not at all, very little, little, moderately, considerably, very considerably, maximum possible). Scores range between 10 and 70, with higher scores indicating greater difficulties.
Through study completion, an average of 18 weeks
Change Interview
Time Frame: Up to 18 weeks
Participant view of change according to a semi-structured interview of ten key questions.
Up to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lincoln

Collaborators

Lincolnshire Partnership NHS Foundation Trust

Investigators

  • Study Chair: David Dawson, DClinPsy, University of Lincoln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

August 20, 2021

Study Completion (ACTUAL)

September 14, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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