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Therapist-Guided Smartphone-Delivered CBT for MDD

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: Mindset: Therapist-guided smartphone-delivered CBT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05386329
2020P001958

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Therapist-guided smartphone-delivered CBT
Experimental group
Description:
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.
Treatment:
Behavioral: Mindset: Therapist-guided smartphone-delivered CBT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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