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Clinical Trials/NCT04376723
NCT04376723
Completed
N/A

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

University of Lincoln1 site in 1 country5 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
University of Lincoln
Enrollment
5
Locations
1
Primary Endpoint
Kessler 10
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
September 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Warwick-Edinburgh Mental Wellbeing Scale(Through study completion, an average of 18 weeks)
  • CompACT-8(Through study completion, an average of 18 weeks)

Study Sites (1)

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