Psychological DistressNCT04376723
Mental Health Apps for Mild Psychological Distress Amongst Adolescents
A study testing Mental Health Mobile Application in people with Psychological Distress, run by University of Lincoln at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Mental Health Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lincolshire Partnership NHS Foundation Trust
Lincoln, Lincolnshire, LN5 7RZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- Mental Health Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Mobile ApplicationOther
Mobile phones will not be provided to participants, but app subscriptions will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mental Health Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 18 weeks
Secondary outcomes (2)
Warwick-Edinburgh Mental Wellbeing Scale
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.
Measured: Through study completion, an average of 18 weeks
CompACT-8
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.
Measured: Through study completion, an average of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Sep 2020
- Primary completion20 Aug 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Lincolnshire Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- David Dawson, DClinPsy, Study chair, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376723
- Sponsor's protocol ID
- 20010
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28546138Badesha 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.
PubMed 36345016
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Mobile Application Self-Help for Adolescents Exhibiting Mild Psychological Distress: A Single Case Experimental Design
- ClinicalTrials.gov ID
- NCT04376723
- Acronym / sponsor ID
- 20010
- Conditions
- Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- Lincolnshire Partnership NHS Foundation Trust
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assisted self-guidance | Experimental | Other: Mental Health Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Health Mobile ApplicationMobile phones will not be provided to participants, but app subscriptions will be provided. | Other | Assisted self-guidance |
Primary outcome
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.
2 secondary outcomes
Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Through study completion, an average of 18 weeks
CompACT-8
Time frame: Through study completion, an average of 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 28546138Grist 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.
- Derived from this study: PubMed 36345016Badesha 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Dawson, DClinPsy study chair
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Mobile Application in people with Psychological Distress, run by University of Lincoln at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler 10 (time frame: Through study completion, an average of 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.