Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Computerized Intervention for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02655588
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
William Stone, Beth Israel Deaconess Medical Center

Brief Summary:
The primary purpose of this study is to examine how much change in depressive symptoms will be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a control group at pre-, mid-point, and post-test assessments.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Interactive Media-Based Problems Solving Treatment Not Applicable

Detailed Description:

An interactive multimedia computer-based treatment program was developed to provide an electronic version of problem solving therapy for depression (imbPST). The program was entirely automated and did not require the involvement of a live clinician, even though it was designed to provide a "virtual therapy" experience that feels more like interacting with a person than with a computer. The imbPST program was built to help individuals who did not have access to traditional therapy due the living conditions or individual preferences (e.g. rural, poor and persons desiring privacy or with significant time constraints). This computer-based treatment of depression offered several advantages. It can be used anywhere without a therapist present, and offered a standardized and consistent therapeutic approach.

The aim of this study is to reduce symptoms of depression in subjects through the use of a new, electronic Problem Solving Treatment (imbPST). Adult participants with moderate to severe depression symptoms are randomly assigned to either treatment or a wait-list condition. The Beck Depression Inventory-II was used as the primary outcome measure


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Computerized Intervention for Depression
Study Start Date : September 2014
Actual Primary Completion Date : October 20, 2016
Actual Study Completion Date : October 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ImbPST
ImbPST Arm: Participants in this arm will interact with imbPST program which provides a simulated therapy session based on the Problem Solving Treatment-Primary Care (PST-PC) treatment manual used in depression clinical trials . imbPST via a "virtual" therapist (presented via audio and video) provides programmed instructions on the steps and skills of problem solving, emotional support, and tailored feedback to the user's input.
Behavioral: Interactive Media-Based Problems Solving Treatment
No Intervention: Control Group
Control Arm: Participants in this group will not receive any treatment for their depression and their depressive symptoms will be monitored for 6 to 9 weeks



Primary Outcome Measures :
  1. Symptoms of Depression will be assessed by using the Beck Depression Inventory II [ Time Frame: Within the first 9 weeks after initiating treatment. ]
    Self-report measure for symptoms of depression


Secondary Outcome Measures :
  1. Software usability will be measured by the System Usability Scale [ Time Frame: at baseline (week 0),and post-treatment ( week 9) ]
    Self-report measure

  2. Symptoms of Depression will be assessed by using the Hopkins Symptom Checklist 20-item Depression Scale ( Self-report) [ Time Frame: Within the first 9 weeks after initiating treatment. ]
    Self-report measure for symptoms of depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be 18 years of age or older.
  2. Present symptoms from the following criteria based on the Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR): Major Depressive Episode, Mood Disorder Due to a General Medical Condition and/or Adjustment Disorder with Depressed Mood.
  3. Depression must be the primary diagnosis and not occur secondary to any another diagnosis such as Post-Traumatic Stress Disorder (PTSD), social phobia, or complicated bereavement, though comorbid diagnoses (e.g., anxiety disorders and PTSD) will not be exclusionary unless they are primary, except as specified below.
  4. Not receiving psychological treatment (e.g., face to face) at the time of the study.
  5. Not currently be receiving Problem Solving Treatment in any other context.
  6. Not reporting/reported suicidal attempts in the year prior to their participation in the study.
  7. Be able to write and speak English according to Rapid Estimate of Adult Literacy in Medicine (REALM test scores)

Exclusion Criteria:

  1. Current suicidal ideation, history of suicidal attempts or self-injurious behavior at any point during the protocol.
  2. Have been diagnosed with schizophrenia, bipolar I disorder, with psychosis, other disorder with psychotic symptoms, and/or brain injuries that includes loss of consciousness > 15 minutes and / post-traumatic amnesia of any duration.
  3. Any history of treatment with anti-psychotic medication.
  4. A felony conviction.
  5. Any current or recent (i.e. within the previous 6 months) substance abuse/dependence diagnosis (other than nicotine or caffeine).
  6. Current psychological treatment (e.g., face to face).

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): NCT02655588


Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
William Stone
Harvard University
Investigators
Layout table for investigator information
Principal Investigator: William Stone, Ph.D. Beth Israel Deaconess Medical Center

Publications:
Layout table for additonal information
Responsible Party: William Stone, Assistant Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02655588     History of Changes
Other Study ID Numbers: 2013P000384
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders