Self-Guided Depression Treatment on Long-Duration Spaceflights: A Continuation Study
Recruitment status was: Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Self-Guided Depression Treatment on Long-Duration Spaceflights: A Continuation Study|
- Hamilton Depression Inventory [ Time Frame: Pre and post-intervention ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Behavioral: Computer-based Problem-Solving Treatment
6 sessions of problem-solving treatment delivered via computer
No Intervention: Waitlist control
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906581
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02120|
|Principal Investigator:||James A Cartreien, PhD||Beth Israel Deaconess Medical Center|