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Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-delivered CBT for MDD
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Current diagnosis of primary DSM-5 MDD, based on MINI
  • Currently living in the United States

Exclusion Criteria:

  • Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
  • Past participation in ≥ 4 sessions of CBT for depression
  • Current severe substance use disorder
  • Lifetime bipolar disorder or psychosis
  • Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
  • 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Smartphone-delivered CBT for MDD

8 Week Waitlist Control

Arm Description

8-week Smartphone delivered CBT for MDD.

8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).

Outcomes

Primary Outcome Measures

Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.
The Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27). **** EDIT

Secondary Outcome Measures

Difference in functional impairment at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on functional impairment (WSAS). The WSAS uses a Likert scale from 0 (not impaired at all) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.
Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).

Full Information

First Posted
October 13, 2020
Last Updated
October 10, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04594616
Brief Title
Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)
Official Title
Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2024 (Anticipated)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).
Detailed Description
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-delivered CBT for MDD
Arm Type
Experimental
Arm Description
8-week Smartphone delivered CBT for MDD.
Arm Title
8 Week Waitlist Control
Arm Type
Other
Arm Description
8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).
Intervention Type
Device
Intervention Name(s)
Smartphone-delivered CBT for MDD
Intervention Description
8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.
Primary Outcome Measure Information:
Title
Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.
Description
The Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27). **** EDIT
Time Frame
Endpoint (week 8)
Secondary Outcome Measure Information:
Title
Difference in functional impairment at the end of treatment/waitlist period
Description
Participants who receive app-CBT will have greater improvement on functional impairment (WSAS). The WSAS uses a Likert scale from 0 (not impaired at all) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.
Time Frame
Endpoint (week 8)
Title
Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF
Description
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Time Frame
Endpoint (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Current diagnosis of primary DSM-5 MDD, based on MINI Currently living in the United States Exclusion Criteria: Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period) Past participation in ≥ 4 sessions of CBT for depression Current severe substance use disorder Lifetime bipolar disorder or psychosis Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Wolfe, BA
Phone
617-726-6531
Email
ewolfe1@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Greenberg, Psy.D.
Phone
617-726-5374
Email
jlgreenberg@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

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