Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression
- Conditions
- Depression
- Interventions
- Behavioral: Treatment as UsualBehavioral: dCBI
- Registration Number
- NCT05159713
- Lead Sponsor
- University of Pittsburgh
- Brief 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.
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as Usual (TAU) Treatment as Usual 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. dCBI + Treatment as Usual Treatment as Usual 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. dCBI + Treatment as Usual dCBI 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.
- Primary Outcome Measures
Name Time Method Change in depression severity 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.
- Secondary Outcome Measures
Name Time Method Change in quality of life 12 weeks 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.Change in depression severity; evidence of passive suicidal ideation 12 weeks 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.Change in anxiety severity 12 weeks 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.Change in general level of functioning 12 weeks 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.
Trial Locations
- Locations (3)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States