Depression
Conditions
Brief summary
This pilot, three-arm randomized clinical trial (N=40; 2:1:1) will evaluate the feasibility and preliminary efficacy of a digitally enhanced stepped-care approach for depression treatment in primary care. Participants will be randomized to: (1) stepped-care beginning with a self-guided Behavioral Activation app (Moodivate), with stepping to clinician-delivered telebehavioral health Behavioral Activation at Week 2 based on app engagement and early PHQ-9 change; (2) telebehavioral health Behavioral Activation; or (3) Moodivate alone. The primary endpoint is feasibility of the stepped-care approach, defined as continued engagement after stepping (≥1 Moodivate use/week for \>4 weeks or ≥4 therapy sessions). The secondary endpoint is change in PHQ-9 scores from baseline through Week 12. The study will be conducted within MUSC Primary Care clinics across South Carolina using remote screening, e-consent, and REDCap assessments.
Interventions
BEHAVIORALBehavioral Activation Therapy App
Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* elevated depression symptoms (score of \>=10 on the PHQ-9) * age \>=18 years * owns an iOS or Android smartphone * willing to use Moodivate * willing to engage in telehealth depression treatment * access to email or text messaging (for assessments) * English fluency
Exclusion criteria
* current receipt of psychosocial depression treatment (e.g., individual or group therapy) * current suicidal ideation, defined as a response \>=1 ("several days") on PHQ-9 item nine * does not live in the state of South Carolina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Digitally Enhanced Stepped-Care | 12 weeks | We operationalize feasibility as continued engagement after stepping, defined as either using Moodivate at least once per week for \>4 weeks (for engagers) or attending \>4 telebehavioral health sessions (for non-engagers). We selected 4 treatment sessions as meaningful engagement because all BA concepts are introduced to patients within sessions 1-4, and sessions 5-8 primarily reinforce previous concepts. Because a strength of self-guided DMHIs is highly flexible pacing, we opt to base meaningful DMHI engagement on continued app use over time, for a duration of \>4 weeks to be comparable to the BA feasibility benchmark. Digitally enhanced stepped-care will be considered feasible if \>75% of participants meet these feasibility benchmarks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Over Time in Depression Severity | 12 weeks | Depression will be assessed via the PHQ-9 at baseline and all follow-ups. The PHQ-9 has high sensitivity and specificity for identifying depression. |
Countries
United States
Contacts
CONTACTNoelle Natale
CONTACTMcKay Lucas
PRINCIPAL_INVESTIGATORJennifer Dahne, PhD
Medical University of South Carolina
Outcome results
None listed