Digitally Enhanced Stepped-Care for Depression in Primary Care
7. juli 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Noelle Natale
- Telefonnummer: 843-876-9457
- E-post: natalen@musc.edu
Studer Kontakt Backup
- Navn: McKay Lucas
- Telefonnummer: 843-876-2611
- E-post: lucasmc@musc.edu
Studiesteder
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Medical University of South Carolina
-
Ta kontakt med:
- Jennifer Dahne, PhD
- Telefonnummer: 843-876-2280
- E-post: dahne@musc.edu
-
Hovedetterforsker:
- Jennifer Dahne, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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 økter med telehelse-levert atferdsaktivering med en psykisk helsepersonell over en 10 ukers periode.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of Digitally Enhanced Stepped-Care
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change Over Time in Depression Severity
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jennifer Dahne, PhD, Medical University of South Carolina
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. juli 2026
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00150034
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .