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

NCT05159713 | Completed DMC

• 1 other identifier: STUDY21080150
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

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).

Conditions

Depression

Keywords

mobile app; digital behavioral tool; adolescent and young adult

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Change in depression severity; evidence of passive suicidal ideation

  12 weeks

• Change in anxiety severity

  12 weeks

• Change in quality of life

  12 weeks

• Change in general level of functioning

  12 weeks

Study Arms (2)

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.

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.

Behavioral: dCBI; Behavioral: Treatment as Usual

Interventions

dCBI BEHAVIORAL

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.

dCBI + Treatment as Usual

Treatment as Usual BEHAVIORAL

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 as Usual (TAU); dCBI + Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (3)

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 37001917 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Eva Szigethy

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinician rated rated measures Children's Depression Rating Scale Revised (CDRS-R) and Clinical Global Assessment Scale (CGAS) will be completed by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Medicine

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: June 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)