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

NCT ID: NCT00906581

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-09-30

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

1. 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.

2. 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.

3. 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral

Behavioral

Group Type: EXPERIMENTAL

Computer-based Problem-Solving Treatment

Intervention Type: BEHAVIORAL

6 sessions of problem-solving treatment delivered via computer

Waitlist control

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer-based Problem-Solving Treatment

6 sessions of problem-solving treatment delivered via computer

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: collaborator

National Space Biomedical Research Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James A. Cartreine

Instructor in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A Cartreien, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23611902 (View on PubMed)

Other Identifiers

2003P000281

Identifier Type: -

Identifier Source: org_study_id