NCT01337726

Brief Summary

The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

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

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 5, 2017

Status Verified

May 1, 2016

Enrollment Period

5.1 years

First QC Date

March 24, 2011

Last Update Submit

April 4, 2017

Conditions

Keywords

DepressionHeart FailureChronic Obstructive Pulmonary DiseaseQuality of LifeFunctional Impairment

Outcome Measures

Primary Outcomes (1)

  • Reduction in depressive symptoms

    Change from Baseline in depressive symtoms at 10 weeks

    10 weeks

Secondary Outcomes (1)

  • Improvement in quality of life/functioning

    10 weeks

Study Arms (2)

Illness Management Only

ACTIVE COMPARATOR
Behavioral: Illness Management Only

Combined Psychotherapy & Illness Management

EXPERIMENTAL
Behavioral: Combined Psychotherapy and Illness Management

Interventions

Participants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks.

Combined Psychotherapy & Illness Management

Participants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks.

Illness Management Only

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years or older
  • Diagnosis of Heart Failure or COPD
  • Depressive symptoms indicated by a BDI-II score of 10 or higher
  • Functional impairment

You may not qualify if:

  • Current psychotherapy
  • Cognitive Impairment
  • Psychiatric diagnosis
  • Active suicidal thoughts
  • Significant vision or hearing impairment
  • Residence in long term care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iowa City VA Health Care System

Iowa City, Iowa, 52242, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

DepressionHeart FailurePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHeart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carolyn L. Turvey, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2011

First Posted

April 19, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

April 5, 2017

Record last verified: 2016-05

Locations