NCT00218556

Brief Summary

The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2015

Enrollment Period

4.4 years

First QC Date

September 20, 2005

Last Update Submit

January 11, 2017

Conditions

Depressive Disorder, MajorHepatitis C

Keywords

Hepatitis C, Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • depression-related antiviral treatment failure

    6 months

Study Arms (2)

Depression prevention

EXPERIMENTAL

Cognitive behavioral treatment for depression.

Behavioral: Cognitive behavioral treatment for depression

Control

NO INTERVENTION

Treatment as usual.

Interventions

Cognitive behavioral treatment for depressionBEHAVIORAL

Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C

Depression prevention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently undergoing HCV treatment at RIH
  • Enrolled in MMT for at least 6 months

You may not qualify if:

  • Current major depressive episode
  • Current suicidality
  • Currently taking antidepressant medication
  • Received HCV treatment in past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorHepatitis CDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Susan E Ramsey, Ph.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Research)

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 12, 2017

Record last verified: 2015-10

Locations

US(1)