Digitally Enhanced Stepped-Care for Depression in Primary Care
7 juli 2026 uppdaterad av: Jennifer Dahne, Medical University of South Carolina
Digitally Enhanced Stepped-Care for Depression in Primary Care: A Pilot Randomized Clinical Trial to Support Scalable Deployment and Commercialization
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Noelle Natale
- Telefonnummer: 843-876-9457
- E-post: natalen@musc.edu
Studera Kontakt Backup
- Namn: McKay Lucas
- Telefonnummer: 843-876-2611
- E-post: lucasmc@musc.edu
Studieorter
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna, 29425
- Rekrytering
- Medical University of South Carolina
-
Kontakt:
- Jennifer Dahne, PhD
- Telefonnummer: 843-876-2280
- E-post: dahne@musc.edu
-
Huvudutredare:
- Jennifer Dahne, PhD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Digitally-Enhanced Stepped Care
Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors.
Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application.
Moodivate is a mobile app for individuals with elevated symptoms of depression.
Within the app, users identify values, create activities, schedule activities, and rate mood daily.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.
|
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.
|
|
Experimentell: Moodivate Only
Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood.
Participants in the Moodivate group will receive a download code to download the Moodivate mobile application.
Moodivate is a mobile app for individuals with elevated symptoms of depression.
Within the app, users identify values, create activities, schedule activities, and rate mood daily.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 12.
|
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.
|
|
Aktiv komparator: Telebehavioral Health
Participants randomized to the Telebehavioral Health condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period.
Participants will be asked to complete questionnaire measures at baseline and weeks 1, 2, 4, 6, 8, and 10.
|
8 sessioner av telehealth-levererad beteendeaktivering med en mentalhälsoleverantör under en 10-veckors period.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of Digitally Enhanced Stepped-Care
Tidsram: 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.
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change Over Time in Depression Severity
Tidsram: 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.
|
12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jennifer Dahne, PhD, Medical University of South Carolina
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 juli 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00150034
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .