Adolescent DepressionNCT04603053
Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT
A study testing mHealth app in people with Adolescent Depression and Anxiety Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Depression, Anxiety Disorders
- What is being tested?
- mHealth app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 20 Aug 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.
Who cannot join
- Adolescents with the following conditions (identified by parental report) will be excluded:
- Participated in formal CBT within the past 12-months
- Diagnosed with severe depression
- Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
- A psychiatric hospitalization in the previous month
- With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
Show all 10Show fewer
- Are not accompanied by a guardian to the diagnostic visit
- Without access to a mobile device (cell phone or tablet) for regular use
- Unable to read and write English
- Participants may also be excluded at the discretion of the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety
Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.
Read the detailed description
In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents.
The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.
- Conditions
- Adolescent Depression, Anxiety Disorders
- Being tested
- mHealth app
- Keywords
- Cognitive Behavioral Therapy, mHealth
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth appBehavioural
Participants will receive access to CBot-A app for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CBot-A Group | Experimental | Participants randomly assigned to this arm will receive access to CBot-A app. Receives: Behavioral: mHealth app |
| Wait List Group | No intervention | Participants randomly assigned to this arm will be offered the intervention after the completion of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms
Measured: 1 month
Secondary outcomes (1)
General Anxiety Disorder-7 (GAD-7)
This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start9 Nov 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
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 Adolescent DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University Institute of Clinical and Translational Sciences
- Responsible party
- Principal investigator, Jane Garbutt, MD, Washington University School of Medicine
- Investigators
- Jane Garbutt, MB, ChB, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603053
- Sponsor's protocol ID
- 202005103
- Status last verified
- Jul 2022
- First submitted
- 16 Oct 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nicol G, Wang R, Graham S, Dodd S, Garbutt J. Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study. JMIR Form Res. 2022 Nov 22;6(11):e40242. doi: 10.2196/40242.
PubMed 36413390
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety
- ClinicalTrials.gov ID
- NCT04603053
- Acronym / sponsor ID
- 202005103
- Conditions
- Adolescent Depression, Anxiety Disorders
- Keywords
- Cognitive Behavioral Therapy, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Washington University Institute of Clinical and Translational Sciences
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 26 Oct 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.
Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.
Detailed description
In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents.
The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBot-A Group | Experimental | Behavioral: mHealth appParticipants randomly assigned to this arm will receive access to CBot-A app. |
| Wait List Group | No intervention | –Participants randomly assigned to this arm will be offered the intervention after the completion of the trial. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.
Key exclusion criteria (10 listed)
- Adolescents with the following conditions (identified by parental report) will be excluded:
- Participated in formal CBT within the past 12-months
- Diagnosed with severe depression
- Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
- A psychiatric hospitalization in the previous month
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 |
|---|---|---|
| mHealth appParticipants will receive access to CBot-A app for 12 weeks. | Behavioural | CBot-A Group |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1 month
The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms
1 secondary outcome
General Anxiety Disorder-7 (GAD-7)
Time frame: 1 month
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 19 Jul 2022.
- Derived from this study: PubMed 36413390Nicol G, Wang R, Graham S, Dodd S, Garbutt J. Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study. JMIR Form Res. 2022 Nov 22;6(11):e40242. doi: 10.2196/40242.
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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.
Jane Garbutt, MB, ChB principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth app in people with Adolescent Depression and Anxiety Disorders, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 10 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 19 Jul 2022. 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 States. 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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 1 month). 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 NCT04603053, 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 19 Jul 2022.