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

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ClinicalTrials.gov Identifier: NCT03769350
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Telefónica S.A.
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

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 QIDS-C scores than those in the waitlist condition at treatment endpoint (week 8).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Smartphone-delivered CBT for MDD Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smartphone-delivered CBT for MDD
8-week Smartphone delivered CBT for MDD.
Device: Smartphone-delivered CBT for MDD
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.

8 Week Waitlist Control
8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).
Device: Smartphone-delivered CBT for MDD
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 Measures :
  1. Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period. [ Time Frame: Endpoint (week 8) ]
    The Quick Inventory of Depressive Symptomatology- Clinician version (QIDS-C) 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).


Secondary Outcome Measures :
  1. Difference in functional impairment at the end of treatment/waitlist period [ Time Frame: Endpoint (week 8) ]
    Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.

  2. Difference in quality of life at the end of treatment/waitlist period [ Time Frame: Endpoint (week 8) ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769350


Contacts
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Contact: Anna Schwartzberg, BA 617-724-7161 aschwartzberg@mgh.harvard.edu
Contact: Hilary Weingarden, PhD 6176436206 Hilary_Weingarden@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Anna Schwartzberg, BA    617-724-7161    aschwartzberg@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Telefónica S.A.
Investigators
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Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital

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Responsible Party: Sabine Wilhelm, PhD, Chief of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03769350     History of Changes
Other Study ID Numbers: 2018P001670
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms