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Self-guided Depression Treatment on Long-duration Spaceflights: A Continuation Study

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-based Problem-Solving Treatment
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Criteria for matching to astronaut corps population:

    • Completed 4 or more years of college or university education
    • Age 30-60
    • Has access to a personal computer and regularly uses it (at least twice per week)
  2. Clinical criteria:

    • Score of 10 or higher on Hamilton Depression Inventory (which yields equivalent scores to the Hamilton Depression Rating Scale).
    • Has a diagnosis of minor depression consisting of 2 to 4 DSM-IV symptoms of depression, one of which is depressed mood or anhedonia
    • Presence of depressive symptoms for at least 2 weeks but less than 2 years
    • Patient willing to avoid or postpone the use of antidepressant drugs during the treatment portion of the study (6 weeks)

Exclusion Criteria:

  1. Presence of more severe depression or dysthymia within the past 6 months (to rule out persons currently remitting from major depression)
  2. Current or past diagnosis of organic mental disorder, schizophrenia, bipolar disorder, or current psychotic symptoms
  3. Current suicidal ideation or any history of suicide attempt or self-injurious behavior
  4. Presence of comorbid antisocial personality disorder
  5. Any current substance abuse/dependence (other than nicotine or caffeine)
  6. Suicidal ideation or parasuicidality
  7. Current homicidal ideation
  8. Recent regimen changes within the past 2 months in prescribed antidepressants, benzodiazepines, or buspirone
  9. Currently receiving psychotherapy or mental health counseling
  10. Exposure to PST in previous studies
  11. Moderate or sever cognitive impairment (Mini Mental State Score <= 23)
  12. Near terminal medical illness (physician estimates < 6 months to live)

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral

Waitlist control

Arm Description

Behavioral

Waitlist control

Outcomes

Primary Outcome Measures

Hamilton Depression Inventory

Secondary Outcome Measures

Full Information

First Posted
March 19, 2009
Last Updated
April 11, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dartmouth-Hitchcock Medical Center, National Space Biomedical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00906581
Brief Title
Self-guided Depression Treatment on Long-duration Spaceflights: A Continuation Study
Official Title
Self-guided Depression Treatment on Long-duration Spaceflights: A Continuation Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dartmouth-Hitchcock Medical Center, National Space Biomedical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Use of a computer-based treatment will reduce level of depression.
Detailed Description
Objective Depression can present a significant threat to long-duration space missions, and crews need the ability to recognize it and treat it effectively. We are developing a prototype computer-based system that includes a module for the recognition and treatment of depression. Before being used by astronauts, this system needs to be further developed and tested for efficacy in an analog population. The countermeasure we are developing is intended for use both in pre-flight training and on the International Space Station. The program has substantial Earth benefits. Aims Complete development of the module for recognizing and preventing depression. We will complete this module, moving from the prototype stage to a completed computer-based tool. We will modify the design based on data from our usability and acceptability study with astronauts at NASA Johnson Space Center. We will pilot-test the module with five participants and make revisions based on their input. Develop the module for implementing computer-based Problem-Solving Treatment (PST). Currently, problem-solving treatment is done using a practitioner who guides the patient through this structured therapy and follows their progress. These practitioners are trained to administer the therapy through a formalized training program that incorporates a workbook and instructional videos. These materials are well suited for presentation via multimedia on computers to make the treatment self-guided. The PST intervention will be modified from its current video/workbook form to a computer-based form that can be used by astronauts or other professionals who are suffering from depression. Evaluate the efficacy of the computer-delivered PST module for depression in a randomized, controlled trial. Hypotheses related to this aim are that, compared to a waiting-list control: Individuals receiving computer-delivered PST will show a greater reduction in depression symptoms, as rated by a clinician. Individuals receiving computer-delivered PST will show a greater reduction in depression, as rated by self-report. A greater proportion of individuals receiving computer-delivered PST will have remitted at post-treatment. Earth-based Applications of Research Project Depression is widespread, and effective treatments are not available to all persons who have it. This computer-based depression treatment, with simple modifications and revisions, could be adapted for use in other isolated, operational environments, such as polar research stations, submarines, commercial ships, oil rigs and underwater research facilities. Furthermore, even greater value could be derived by making similar psychosocial support systems available to the public in settings such as primary care practices, public and mental health centers, schools, social services offices, places of worship, military bases, prisons, and eventually at home or in any location, through broadband Internet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Behavioral
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Waitlist control
Intervention Type
Behavioral
Intervention Name(s)
Computer-based Problem-Solving Treatment
Intervention Description
6 sessions of problem-solving treatment delivered via computer
Primary Outcome Measure Information:
Title
Hamilton Depression Inventory
Time Frame
Pre and post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Criteria for matching to astronaut corps population: Completed 4 or more years of college or university education Age 30-60 Has access to a personal computer and regularly uses it (at least twice per week) Clinical criteria: Score of 10 or higher on Hamilton Depression Inventory (which yields equivalent scores to the Hamilton Depression Rating Scale). Has a diagnosis of minor depression consisting of 2 to 4 DSM-IV symptoms of depression, one of which is depressed mood or anhedonia Presence of depressive symptoms for at least 2 weeks but less than 2 years Patient willing to avoid or postpone the use of antidepressant drugs during the treatment portion of the study (6 weeks) Exclusion Criteria: Presence of more severe depression or dysthymia within the past 6 months (to rule out persons currently remitting from major depression) Current or past diagnosis of organic mental disorder, schizophrenia, bipolar disorder, or current psychotic symptoms Current suicidal ideation or any history of suicide attempt or self-injurious behavior Presence of comorbid antisocial personality disorder Any current substance abuse/dependence (other than nicotine or caffeine) Suicidal ideation or parasuicidality Current homicidal ideation Recent regimen changes within the past 2 months in prescribed antidepressants, benzodiazepines, or buspirone Currently receiving psychotherapy or mental health counseling Exposure to PST in previous studies Moderate or sever cognitive impairment (Mini Mental State Score <= 23) Near terminal medical illness (physician estimates < 6 months to live)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Cartreien, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23611902
Citation
Cartreine JA, Locke SE, Buckey JC, Sandoval L, Hegel MT. Electronic problem-solving treatment: description and pilot study of an interactive media treatment for depression. JMIR Res Protoc. 2012 Sep 25;1(2):e11. doi: 10.2196/resprot.1925.
Results Reference
derived

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Self-guided Depression Treatment on Long-duration Spaceflights: A Continuation Study

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