Therapist-Guided Smartphone-Delivered CBT for MDD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-08-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventional study without concurrent control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapist-guided smartphone-delivered CBT

Participants will complete app-based cognitive-behavioral therapy (CBT) treatment for major depressive disorder (MDD) through their personal mobile smartphone. They will also be assigned a therapist, who will provide brief virtual treatment sessions (up to 25 minutes via a video platform) over the course of the same treatment period.

Group Type EXPERIMENTAL

Mindset: Therapist-guided smartphone-delivered CBT

Intervention Type BEHAVIORAL

All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants.

Interventions

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Mindset: Therapist-guided smartphone-delivered CBT

All participants will receive the app-delivered CBT, including modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., activity scheduling), and mindfulness. Therapists will also conduct brief weekly virtual appointments with participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No