N/A
N=28
Therapist-Guided Smartphone-Delivered CBT for MDD
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05386329 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Drop-Out Rates — 2; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindset: Therapist-guided smartphone-delivered CBT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drop-Out Rates |
2; 26 | — |
| PRIMARY Change in Patient Satisfaction (as Measured by the CSQ-8) |
26.3; 27.2 | =.0719 |
| PRIMARY Change in Treatment Credibility (as Measured by the CEQ) |
18.9; 19.3 | =.6316 |
| PRIMARY Change in Outcome Expectancy (as Measured by the CEQ) |
13.8; 15.0 | =.2225 |
| PRIMARY App Rating (as Measured by the uMARS) |
3.6; 4.5; 4.6; 4.6; 4.3 | — |
| PRIMARY Change in Treatment Utilization |
50; 60 | =.7873 |
| SECONDARY Change in MDD Symptom Severity (as Measured by the HAM-D) |
19.1; 15.0; 10.8; 9.8 | <.0001 sig |
| SECONDARY Change in Functional Impairment (as Measured by the WSAS) |
23.1; 18.6; 13.0; 12.3 | <.0001 sig |
| SECONDARY Change in Quality of Life (as Measured by the Q-LES-Q-SF) |
40.9; 52.4; 62.9; 63.6 | <.0001 sig |
Summary
We are testing a smartphone app that provides therapy for depression. Participants will also receive short weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.
Eligibility Criteria
Inclusion Criteria
- Adults
- Living in Massachusetts
- Current primary diagnosis of depression
- at least moderately severe current symptoms of depression
Exclusion Criteria
- Recent or anticipated changes in psychotropic medication use
- Past participation in a course of CBT for depression
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation
- Concurrent psychological treatment
- Does not own a supported mobile Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Data sourced from ClinicalTrials.gov (NCT05386329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.