Clinical trial NCT05159713: Study to Compare the Use of a Behavioral Health App Versus Care As Usual for 16-22 Year Olds with Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: mobile app
digital behavioral tool
adolescent and young adult
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 185
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in depression severity; evidence of passive suicidal ideation
timeFrame: 12 weeks
measure: Change in anxiety severity
timeFrame: 12 weeks
measure: Change in quality of life
timeFrame: 12 weeks
measure: Change in general level of functioning
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eva Szigethy
role: PRINCIPAL_INVESTIGATOR
References: