NCT00906581

Brief Summary

Use of a computer-based treatment will reduce level of depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

March 19, 2009

Last Update Submit

April 11, 2017

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Inventory

    Pre and post-intervention

Study Arms (2)

Behavioral

EXPERIMENTAL

Behavioral

Behavioral: Computer-based Problem-Solving Treatment

Waitlist control

NO INTERVENTION

Waitlist control

Interventions

Computer-based Problem-Solving TreatmentBEHAVIORAL

6 sessions of problem-solving treatment delivered via computer

Behavioral

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • 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.

    PMID: 23611902DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • James A Cartreien, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Psychiatry

Study Record Dates

First Submitted

March 19, 2009

First Posted

May 21, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)