DepressionNCT05159713
Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression
A study testing dCBI and Treatment as Usual in people with Depression, run by University of Pittsburgh at 3 sites in United States.
Trial summary
Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Depression
- What is being tested?
- dCBI and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2022to 30 Aug 2024
- 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 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-22 inclusive recruited from outpatient pediatric clinic visit.
- Meeting positive screen criteria depression by PHQ-9 criteria (score greater than or equal to10).
- English-speaking (participant)
- Smart phone access
Who cannot join
- Extremely severe depression (PHQ-9 greater than 24; or active suicidal plan).
- Current dangerousness (based on Treatment for Adolescents for Depression Study (TADS) study criteria, 2004). Hospitalized for dangerousness within 3 months; Suicide attempt requiring medical attention within 3 months.
- Severe, current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, thought disorder. Research coordinators who are trained to fidelity threshold will complete this measure with the patient.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rady Children's Hospital - San Diego
San Diego, California, 92123
About this study
Official title: Randomized Control Trial to Evaluate the Efficacy of a Digital Mental Health Intervention Embedded in Routine Care Compared to Treatment As Usual in Adolescents and Young Adults with Moderate Depressive Symptoms
Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care.
The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego).
Read the detailed description
After consent, participants will be further screened to determine eligibility. They will complete a brief Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) (SCID). If someone has been hospitalized in the past 3 months for dangerousness, or is diagnosed with severe current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, or thought disorder they will not be eligible for this study and will be referred back to the clinician for further support.
PARTICIPANT PROCEDURES:
All participants who are eligible for this study, consent to participate, and are randomized to one of the two arms (dCBI+TAU or TAU) will be asked to complete self-report and blinded clinician administered measures on three occasions over 12 weeks (baseline, 6-, and 12-week time points). At enrollment and prior to randomization, each participant will be assigned a unique Study ID that will be used to code all data collected for research purposes.
Participants will be asked to complete self-report assessments via 1) self-administered completion of assessments through REDCap Cloud (i.e., online); 2) over the phone with a member of the Research Team who will enter the participant's responses into a secure web-based portal (REDCap Cloud).
- Conditions
- Depression
- Being tested
- dCBI, Treatment as Usual
- Keywords
- mobile app, digital behavioral tool, adolescent and young adult
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCBIBehavioural
The dCBI, RxWell, is a trans-CBT mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. RxWell provides users users with 40 brief (5-10 minute) skill building techniques for anxiety and depression. Users will have access to a goal-setting tab and "in the moment relief" section which contains over 17 techniques,14 of which are brief audios to help users engage relaxation responses. The user will be provided with the depression path, which has 40 unique techniques, and if the user expresses significant anxiety, the coach will have the ability to personalize the program by pulling in any of the 53 techniques from the anxiety path, so that the individual can utilize the proper CBT techniques that fit with their presentation.
Treatment as UsualBehavioural
Participants who are randomly assigned to the Treatment as Usual (TAU) group will receive standard care, which will consist of a tiered stepped care model of behavioral therapy offered by the embedded behavioral therapist at each practice as part of routine care, with the provision of augmentation of therapy (or addition of an antidepressant) at the discretion of the clinical team. Psychotropic medications at baseline and previous behavioral treatment will be recorded at baseline. Number of therapy sessions, delivery modality (face to face versus telemedicine), and addition of antidepressant or other psychotropic medication or dose change will be monitored and recorded over the study period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Other | Participants who are randomly assigned to the Treatment as Usual (TAU) group will receive standard care, which will consist of a tiered stepped care model of behavioral therapy offered by the embedded behavioral therapist at each practice as part of routine care, with the provision of augmentation of therapy (or addition of an antidepressant) at the discretion of the clinical team. Psychotropic medications at baseline and previous behavioral treatment will be recorded at baseline. Number of therapy sessions, delivery modality (face to face versus telemedicine), and addition of antidepressant or other psychotropic medication or dose change will be monitored and recorded over the study period. Receives: Behavioral: Treatment as Usual |
| dCBI + Treatment as Usual | Experimental | Participants randomly assigned to the intervention group (dCBI+TAU) will receive standard care and also gain access to the dCBI. The dCBI, RxWell, is a trans-Cognitive Behavioral Therapy (CBT) mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. Receives: Behavioral: dCBI; Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity
Children's Depression Rating Scale-Revised (CDRS-R) will be administered by a blinded rater from baseline up to 12 weeks after baseline to evaluate the change in depression severity.
The CDRS-R is a 17-item interview, which score can add up to between 17 and 113. A score of greater than or equal to 40 indicates depressive symptomatology, and a score of less than or equal to indicates remission.
Measured: 12 weeks
Secondary outcomes (4)
Change in depression severity; evidence of passive suicidal ideation
Patient Health Questionnaire (PHQ-9) will be utilized to measure change in depression severity and evidence of passive suicidal ideation from baseline up to 12 weeks after baseline.
The PHQ-9 is a 9 item questionnaire. Scores can range from 0-27. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-27 indicates severe depressive symptoms.
Measured: 12 weeks
Change in anxiety severity
Generalized Anxiety Disorder (GAD7) will be utilized to measure change in anxiety severity from baseline up to 12 weeks after baseline.
GAD-7 is a 7 item questionnaire. Scores range from 7-21. Total scores of 0-4 indicates no anxiety; 5-9 mild anxiety; 10-14 moderate anxiety; greater than or equal to 15 indicates severe anxiety.
Measured: 12 weeks
Change in quality of life
Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline.
SWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.
Measured: 12 weeks
Change in general level of functioning
Children's Global Assessment Scale (CGAS) blinded clinician rater will be utilized to measure the level of general functioning from baseline up to 12 weeks after baseline.
CGAS scores range from 1-100 with 100-91 associated with superior functioning and 31-40 with major impairment in functioning in several areas, and unable to function in one of those areas.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Jun 2022
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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 DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Szigethy, University of Pittsburgh
- Investigators
- Eva Szigethy, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159713
- Sponsor's protocol ID
- STUDY21080150
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2021
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared. Data is shared at the aggregate level.
Publications
Szigethy E, Wolfson D, Sinclair-McBride K, Williams K, Jhe G, Lee EH, Bialostozky M, Wallace M, Bhatnagar S, Demaso DR, Yealy DM, Hollenbach K. Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial. BMJ Open. 2023 Mar 31;13(3):e067141. doi: 10.1136/bmjopen-2022-067141.
PubMed 37001917
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Evaluate the Efficacy of a Digital Mental Health Intervention Embedded in Routine Care Compared to Treatment As Usual in Adolescents and Young Adults with Moderate Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05159713
- Acronym / sponsor ID
- STUDY21080150
- Conditions
- Depression
- Keywords
- mobile app, digital behavioral tool, adolescent and young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 16 Dec 2021 (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.
Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care.
The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego).
Detailed description
After consent, participants will be further screened to determine eligibility. They will complete a brief Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) (SCID). If someone has been hospitalized in the past 3 months for dangerousness, or is diagnosed with severe current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, or thought disorder they will not be eligible for this study and will be referred back to the clinician for further support.
PARTICIPANT PROCEDURES:
All participants who are eligible for this study, consent to participate, and are randomized to one of the two arms (dCBI+TAU or TAU) will be asked to complete self-report and blinded clinician administered measures on three occasions over 12 weeks (baseline, 6-, and 12-week time points). At enrollment and prior to randomization, each participant will be assigned a unique Study ID that will be used to code all data collected for research purposes.
Participants will be asked to complete self-report assessments via 1) self-administered completion of assessments through REDCap Cloud (i.e., online); 2) over the phone with a member of the Research Team who will enter the participant's responses into a secure web-based portal (REDCap Cloud).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Other | Behavioral: Treatment as UsualParticipants who are randomly assigned to the Treatment as Usual (TAU) group will receive standard care, which will consist of a tiered stepped care model of behavioral therapy offered by the embedded behavioral therapist at each practice as part of routine care, with the provision of augmentation of therapy (or addition of an antidepressant) at the discretion of the clinical team. Psychotropic medications at baseline and previous behavioral treatment will be recorded at baseline. Number of therapy sessions, delivery modality (face to face versus telemedicine), and addition of antidepressant or other psychotropic medication or dose change will be monitored and recorded over the study period. |
| dCBI + Treatment as Usual | Experimental | Behavioral: dCBI, Behavioral: Treatment as UsualParticipants randomly assigned to the intervention group (dCBI+TAU) will receive standard care and also gain access to the dCBI. The dCBI, RxWell, is a trans-Cognitive Behavioral Therapy (CBT) mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-22 inclusive recruited from outpatient pediatric clinic visit.
- Meeting positive screen criteria depression by PHQ-9 criteria (score greater than or equal to10).
- English-speaking (participant)
- Smart phone access
Key exclusion criteria (3 listed)
- Extremely severe depression (PHQ-9 greater than 24; or active suicidal plan).
- Current dangerousness (based on Treatment for Adolescents for Depression Study (TADS) study criteria, 2004). Hospitalized for dangerousness within 3 months; Suicide attempt requiring medical attention within 3 months.
- Severe, current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, thought disorder. Research coordinators who are trained to fidelity threshold will complete this measure with the patient.
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 |
|---|---|---|
| dCBIThe dCBI, RxWell, is a trans-CBT mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. RxWell provides users users with 40 brief (5-10 minute) skill building techniques for anxiety and depression. Users will have access to a goal-setting tab and "in the moment relief" section which contains over 17 techniques,14 of which are brief audios to help users engage relaxation responses. The user will be provided with the depression path, which has 40 unique techniques, and if the user expresses significant anxiety, the coach will have the ability to personalize the program by pulling in any of the 53 techniques from the anxiety path, so that the individual can utilize the proper CBT techniques that fit with their presentation. | Behavioural | dCBI + Treatment as Usual |
| Treatment as UsualParticipants who are randomly assigned to the Treatment as Usual (TAU) group will receive standard care, which will consist of a tiered stepped care model of behavioral therapy offered by the embedded behavioral therapist at each practice as part of routine care, with the provision of augmentation of therapy (or addition of an antidepressant) at the discretion of the clinical team. Psychotropic medications at baseline and previous behavioral treatment will be recorded at baseline. Number of therapy sessions, delivery modality (face to face versus telemedicine), and addition of antidepressant or other psychotropic medication or dose change will be monitored and recorded over the study period. | Behavioural | Treatment as Usual (TAU), dCBI + Treatment as Usual |
Primary outcome
Change in depression severity
Time frame: 12 weeks
Children's Depression Rating Scale-Revised (CDRS-R) will be administered by a blinded rater from baseline up to 12 weeks after baseline to evaluate the change in depression severity. The CDRS-R is a 17-item interview, which score can add up to between 17 and 113. A score of greater than or equal to 40 indicates depressive symptomatology, and a score of less than or equal to indicates remission.
4 secondary outcomes
Change in depression severity; evidence of passive suicidal ideation
Time frame: 12 weeks
Change in anxiety severity
Time frame: 12 weeks
Change in quality of life
Time frame: 12 weeks
Change in general level of functioning
Time frame: 12 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 21 Oct 2024.
- Derived from this study: PubMed 37001917Szigethy E, Wolfson D, Sinclair-McBride K, Williams K, Jhe G, Lee EH, Bialostozky M, Wallace M, Bhatnagar S, Demaso DR, Yealy DM, Hollenbach K. Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial. BMJ Open. 2023 Mar 31;13(3):e067141. doi: 10.1136/bmjopen-2022-067141.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared. Data is shared at the aggregate level.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Eva Szigethy principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCBI and Treatment as Usual in people with Depression, run by University of Pittsburgh at 3 sites 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 4 inclusion and 3 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in depression severity (time frame: 12 weeks). 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 NCT05159713, 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 21 Oct 2024.