NCT00333710

Brief Summary

The main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. It is hypothesized that

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

December 15, 2014

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

3.1 years

First QC Date

June 2, 2006

Results QC Date

November 19, 2014

Last Update Submit

December 9, 2014

Conditions

Keywords

RehabilitationTelecommunication

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C Virus Knowledge Questionnaire

    This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge

    pre-treatment, post-treatment

Study Arms (3)

Individual face-to-face contact

EXPERIMENTAL

Individual face-to-face contact treatment

Behavioral: Individual psychotherapy

Individual telephone contact

EXPERIMENTAL

Individual telephone contact treatment

Behavioral: Telehealth Intervention

Control condition/treatment as usual

NO INTERVENTION

Control condition/treatment as usual

Interventions

Individual face-to-face contact with educational and goal setting components

Individual face-to-face contact

Individual telephone contact with educational and goal setting components

Individual telephone contact

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of hepatitis C
  • Clinical diagnosis of posttraumatic stress disorder
  • Need to have access to a telephone

You may not qualify if:

  • Life threatening or acute illness
  • Current alcohol or substance dependence
  • Currently prescribed interferon treatment
  • No access to a telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Chronic DiseaseHepatitis CStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

Small sample size, all male, reliance on self-report measures.

Results Point of Contact

Title
Amy Silberbogen, Ph.D.
Organization
VA Boston Healthcare System

Study Officials

  • Amy Silberbogen, PhD

    VA Medical Center, Jamaica Plain Campus

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 15, 2014

Results First Posted

December 15, 2014

Record last verified: 2014-12

Locations