Self-guided Moodivate significantly reduces depressive symptoms vs usual care over 12 weeks.

Background

Most US adults who screen positive for depression in primary care do not receive treatment, underscoring the need for scalable, evidence-based options. Moodivate is a self-guided, mobile behavioral activation program designed to expand access to treatment in primary care without intensive clinician involvement.

Patients

• Adults from 22 primary care clinics in South Carolina (recruited Sept 22, 2021–Dec 27, 2023; data collection through Mar 29, 2024).
• Eligibility: PHQ-9 ≥10 (moderate or higher depression), English proficient, smartphone owner, active patient portal, upcoming primary care appointment, willing to use an app.
• Key exclusions: Acute suicidality on BDI-II item 9, severe visual impairment, no smartphone/portal, non-English.
• Analyzed sample: 649 participants; mean age 44.7 years; 76% female; mean baseline BDI-II 32.9 (severe range); 81% taking a mental/emotional health medication.

Intervention

• Moodivate (digital behavioral activation app): Onboarding tutorial; goal and activity generation across life areas; activity scheduling and monitoring; mood tracking; biweekly PHQ-8 prompts; progress graphs linking activity and mood; gamification (badges).
• Moodivate + EHR integration: Same app plus optional primary care provider (PCP) access to patient engagement data via a smartphrase embedded in the electronic health record (EHR).

Control

• Usual care: EHR-delivered educational materials about mood management and recommendation to discuss depression treatment with the PCP; no restriction on additional treatments.

Outcome

• Primary: Change in depression severity (BDI-II) over 12 weeks.
• Secondary:
  • Clinically significant improvement (≥10-point BDI-II decrease).
  • Depression remission (BDI-II ≤13).
  • Engagement with the digital intervention.
  • PCP use of EHR smartphrase features.

Study Design

• Three-arm, decentralized randomized clinical trial (1:1:1): Moodivate, Moodivate + EHR, or usual care.
• Stratified randomization by baseline severity (BDI-II <29 vs ≥29) and current antidepressant use; intent-to-treat analyses using generalized estimating equations.

Level of Evidence

Level I (randomized controlled trial).

Follow up period

12 weeks.

Results

Primary outcome

• BDI-II change from baseline to 12 weeks (least squares mean ± SE):
  • Moodivate: −10.34 ± 0.82 (Cohen d ≈ 0.98)
  • Moodivate + EHR: −9.88 ± 0.81 (Cohen d ≈ 0.93)
  • Usual care: −5.94 ± 0.80 (Cohen d ≈ 0.54)
  Both Moodivate arms improved more than usual care over time.

Secondary outcomes

• Clinically significant improvement (≥10-point BDI-II decrease) at any time during 12 weeks:
  • Observed proportions: Moodivate 58% (126/216), Moodivate + EHR 62% (136/221), Usual care 51% (109/212).
  • Adjusted odds vs usual care: Moodivate OR 2.98 (97.5% CI, 1.69–5.27); Moodivate + EHR OR 2.53 (97.5% CI, 1.45–4.41).
  • Approximate NNT vs usual care: Moodivate ≈ 15; Moodivate + EHR ≈ 10.
• Depression remission (BDI-II ≤13) at any time during 12 weeks:
  • Observed proportions: Moodivate 33% (72/216), Moodivate + EHR 36% (79/221), Usual care 28% (60/212).
  • Adjusted odds vs usual care: Moodivate OR 2.27 (97.5% CI, 1.16–4.44); Moodivate + EHR OR 2.63 (97.5% CI, 1.38–5.04).
  • Approximate NNT vs usual care: Moodivate ≈ 20; Moodivate + EHR ≈ 14.
• Engagement with the app (both Moodivate arms combined):
  • Median 24 sessions (IQR 11–62); median total use ~59 minutes (IQR 28.8–136.2); median session length ~3.5 minutes.
  • Retention declined from 100% in week 1 to 33% by week 12; 33% continued use at 12 weeks.
  • More badges earned was associated with lower depression scores over time.
• PCP engagement with EHR smartphrase (Moodivate + EHR arm):
  • 14% of PCPs used the smartphrase at least once; resulted in usage for 8% of participants in that arm.

Limitations

• Single-state setting (South Carolina) may limit generalizability.
• Eligibility required English proficiency, smartphone ownership, and patient portal access, potentially biasing the sample.
• Depression outcomes were self-reported; no independent assessor and no measures of functioning or quality of life.
• Open-label design; potential reaction or disappointment effects not assessed.
• Follow-up limited to 12 weeks; longer-term effectiveness unknown.
• Low PCP use of EHR integration; limited evaluation of clinician-facing features.

Funding

National Institute of Mental Health (R42MH108219). Underlying intellectual property for Moodivate is owned by the University of Maryland, College Park; an exclusive commercialization license has been agreed with Behavioral Activation Tech, LLC.

Citation

Dahne J, Wahlquist AE, Carpenter MJ, Graboyes EM, Lejuez CW, Kustanowitz J, Natale N, Levins O, Player M, Diaz VA. A Digital Depression Treatment Program for Adults Treated in Primary Care: A Randomized Clinical Trial. JAMA Internal Medicine. 2025;185(6):692-701. Published online April 14, 2025. doi:10.1001/jamainternmed.2025.0494. ClinicalTrials.gov: NCT04463914.