General Mental Health and Well-BeingNCT02265978
CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People
A study testing CopeSmart in people with General Mental Health and Well-Being, run by University College Dublin at 1 site in Ireland.
Trial summary
This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- General Mental Health and Well-Being
- What is being tested?
- CopeSmart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2014to May 2015
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be between 14 and 19 years
- Must be enrolled in second-level education
- Must have access to an iPhone, iTouch or Android mobile device
- Must obtain signed parental consent to participate
Who cannot join
- No parental consent
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.
- Conditions
- General Mental Health and Well-Being
- Being tested
- CopeSmart
- Keywords
- Emotional Self-Awareness, Positive Coping, Help-Seeking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopeSmartDevice
Participants will use the CopeSmart app at least once per day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| CopeSmart | Experimental | Not described Receives: Device: CopeSmart |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale
Measured: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Secondary outcomes (4)
Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory
Measured: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in levels of well-being measured by the WHO-5 Well-Being Index
Measured: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire
Measured: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale
Measured: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Mental Health and Well-BeingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Research Council
- Responsible party
- Principal investigator, Rachel Kenny, University College Dublin
- Investigators
- Rachel E Kenny, M.Psych.Sc., Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265978
- Sponsor's protocol ID
- GOIPG/2013/450
- Status last verified
- Jul 2015
- First submitted
- 7 Oct 2014
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kenny R, Dooley B, Fitzgerald A. Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study. JMIR Ment Health. 2016 Nov 29;3(4):e51. doi: 10.2196/mental.6361.
PubMed 27899340
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People
- ClinicalTrials.gov ID
- NCT02265978
- Acronym / sponsor ID
- GOIPG/2013/450
- Conditions
- General Mental Health and Well-Being
- Keywords
- Emotional Self-Awareness, Positive Coping, Help-Seeking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Irish Research Council
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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 evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CopeSmart | Experimental | Device: CopeSmart |
| Control | No intervention | – |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Must be between 14 and 19 years
- Must be enrolled in second-level education
- Must have access to an iPhone, iTouch or Android mobile device
- Must obtain signed parental consent to participate
Key exclusion criteria (1 listed)
- No parental consent
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 |
|---|---|---|
| CopeSmartParticipants will use the CopeSmart app at least once per day for four weeks | Device | CopeSmart |
Primary outcome
Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale
Time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
4 secondary outcomes
Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory
Time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in levels of well-being measured by the WHO-5 Well-Being Index
Time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire
Time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale
Time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
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 10 Jul 2015.
- Derived from this study: PubMed 27899340Kenny R, Dooley B, Fitzgerald A. Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study. JMIR Ment Health. 2016 Nov 29;3(4):e51. doi: 10.2196/mental.6361.
- Related InfoLink provided by the sponsor.
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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.
Rachel E Kenny, M.Psych.Sc. principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CopeSmart in people with General Mental Health and Well-Being, run by University College Dublin at 1 site in Ireland.
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 1 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 10 Jul 2015. 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 Ireland. 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?
Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale (time frame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)). 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 NCT02265978, which also lists 1 linked publication.
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 10 Jul 2015.