Clinical trial NCT05386329: Therapist-Guided Smartphone-Delivered CBT for MDD
Official title: Development and Preliminary Testing of a Non-regulated Digital Service That Supports Cognitive Behavioral Therapy for Depressive Symptoms Under Clinical Supervision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Digital Health
Cognitive Behavioral Therapy
Depression
Smartphone Apps
mHealth
Feasibility
Acceptability
Mobile App
Mental Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Koa Health B.V.
First posted: 2022-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional study without concurrent control
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this project is to conduct an open trial to test the feasibility, acceptability, and preliminary efficacy of a new therapist-guided smartphone-delivered cognitive behavioral therapy (CBT) for major depressive disorder (MDD). This treatment will include unlimited access to the mobile CBT for depression app over 8 weeks plus 8 virtual visits with a doctoral-level psychologist or psychology intern with their master's degree. The therapist will be assigned once eligibility is determined. All virtual sessions will be no longer than 16-25 min. The combined CBT app plus virtual treatment will be tested in 28 patients. Clinical assessments will occur at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3 month follow-up. The investigators hypothesize that this treatment will be feasible, acceptable to participants, and lead to reductions in depression symptoms and functional impairment as well as improvements in quality of life from baseline to end-of-treatment.

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

Primary outcomes:
measure: Drop-Out Rates
timeFrame: assessed at end-of-treatment (week 8)
measure: Change in Patient Satisfaction (as Measured by the CSQ-8)
timeFrame: Measured at midpoint (week 4) and end-of-treatment (week 8)
measure: Change in Treatment Credibility (as Measured by the CEQ)
timeFrame: Change in credibility from baseline (week 0) to midpoint (week 4)
measure: Change in Outcome Expectancy (as Measured by the CEQ)
timeFrame: Measured at baseline (week 0) and midpoint (week 4)
measure: App Rating (as Measured by the uMARS)
timeFrame: Measured at endpoint (week 8)
measure: Change in Treatment Utilization
timeFrame: Measured at midpoint (week 4) and end-of-treatment (week 8)
Secondary outcomes:
measure: Change in MDD Symptom Severity (as Measured by the HAM-D)
timeFrame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)
measure: Change in Functional Impairment (as Measured by the WSAS)
timeFrame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)
measure: Change in Quality of Life (as Measured by the Q-LES-Q-SF)
timeFrame: Measured at baseline, week 4, week 8 (end of treatment), week 20 (follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm
role: PRINCIPAL_INVESTIGATOR
References: