Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression

University of Pittsburgh

Status: Completed

Conditions: Depression

Treatments: Behavioral: dCBI; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05159713

STUDY21080150

Details and patient eligibility

About

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).

Full 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).

Enrollment: 185 patients

Sex: All

Ages: 16 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 2 patient groups

Treatment as Usual (TAU)

Other group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

dCBI + Treatment as Usual

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Behavioral: dCBI