Interpersonal Psychotherapy for Depression in People With Heart Failure
Primary Purpose
Depression, Heart Failure, Congestive
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interpersonal and behavioral psychotherapy
Attention control (AC) condition
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Heart Failure, Functional Impairment, Health-Related Quality of Life, Telemedicine
Eligibility Criteria
Inclusion Criteria: Current heart failure Current minor or major depression Score of 14 or higher on the Beck Depression Inventory-II Exclusion Criteria: Score of less than 24 on the Mini-Mental State Exam
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Participants will receive combined interpersonal and behavioral psychotherapy aimed at reducing depression in patients with heart failure.
Participants will receive the attention control condition.
Outcomes
Primary Outcome Measures
Score on the 17-item HRSD
Secondary Outcome Measures
Health-related quality of life
Interpersonal functioning
Behavioral activation
Self care of heart failure
Full Information
NCT ID
NCT00353223
First Posted
July 14, 2006
Last Updated
May 30, 2013
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00353223
Brief Title
Interpersonal Psychotherapy for Depression in People With Heart Failure
Official Title
Interpersonal Psychotherapy for Depression in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral activation techniques in treating depression in people with congestive heart failure.
Detailed Description
This study aims to develop an intervention based on interpersonal psychotherapy (IPT) and behavioral activation (BA) techniques to treat depression in people with congestive heart failure. By addressing how participants' loss of functioning has changed their personal relationships, the psychotherapy will help participants to discuss how they are coping with their illness and loss of functioning. It will also help participants with heart failure to develop new recreational activities in keeping with their new level of functioning. The study will first develop the methods for the intervention and then pilot the study in a small randomized, controlled trial.
Access to care has been a major barrier to treatment in prior psychosocial studies in cardiac patients. Because many people with advanced heart failure are homebound, the treatment in this study will be administered primarily by telephone, which will greatly enhance dissemination of the intervention. The treatment techniques developed will be applicable to a range of homebound patients and frail elderly, not just patients with heart failure. The long-term goal of the study is to develop pragmatic interventions to reduce depression in people coping with irreversible functional decline.
Specific Aim #1 - Treatment Standardization: The purpose of this phase will be to develop an intervention that addresses the emotional and behavioral consequences of heart failure by 1) integrating IPT and BA techniques to address both interpersonal and functional issues related to disability, 2) applying IPT theory of "role transition" and "grief and loss" to coping with functional decline, 3) applying BA interventions to maximize functioning in patients with severe impairment due to medical illness, 4) developing the techniques needed to implement both IPT and BA successfully over the telephone, 5) developing the methods to implement an appropriate attention control (AC) group, 6) generating complementary visual materials for patients to enhance understanding of the therapeutic model, and 7) evaluating a range of functional assessments to be used as alternative outcomes. Two therapists will conduct the treatment by telephone with 15 depressed heart failure patients. Participants' baseline 17-item Hamilton Rating Scale for Depression (HRSD) total score will be compared with the HRSD total score from Weeks 6 and 12.
Specific Aim #2 - Treatment Evaluation: The purpose of this phase will be to pilot the new treatment in a randomized, controlled trial of people suffering major or minor depression. This phase will include the application of therapist training techniques, assessment of treatment fidelity, and selection of optimal outcome, adherence, process, and treatment quality measures. Participants will be randomly assigned to receive IPT or an attention control condition (AC). Both groups will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits lasting 1 to 2 hours. The IPT group will receive IPT designed for people with heart failure. The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Depressive symptoms will be measured for all participants using the HRSD at baseline and Weeks 6 and 12.
Specific Aim #3 - Treatment Feasibility: In both the standardization and evaluation phases, specific treatment feasibility issues will be addressed. The main feasibility issue will be the acceptability and effectiveness of a telephone administered intervention with severely impaired older people. In addition, recruitment and retention issues will be addressed in all stages of treatment development. The main outcome of this aim will be adequate recruitment sources, including adequate representation of minorities, to conduct a large scale R01 intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Heart Failure, Congestive
Keywords
Heart Failure, Functional Impairment, Health-Related Quality of Life, Telemedicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive combined interpersonal and behavioral psychotherapy aimed at reducing depression in patients with heart failure.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Participants will receive the attention control condition.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal and behavioral psychotherapy
Intervention Description
Participants will receive a combined intervention of interpersonal and behavioral psychotherapy designed for people with heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours. The psychotherapy sessions will allow participants to discuss how they are coping with their illness and loss of functioning. They will also aim to help participants with heart failure to develop new recreational activities in keeping with their new level of functioning.
Intervention Type
Behavioral
Intervention Name(s)
Attention control (AC) condition
Intervention Description
The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours.
Primary Outcome Measure Information:
Title
Score on the 17-item HRSD
Time Frame
Measured at Week 12
Secondary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
Measured at Week 12
Title
Interpersonal functioning
Time Frame
Measured at Week 12
Title
Behavioral activation
Time Frame
Measured at Week 12
Title
Self care of heart failure
Time Frame
Measured at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current heart failure
Current minor or major depression
Score of 14 or higher on the Beck Depression Inventory-II
Exclusion Criteria:
Score of less than 24 on the Mini-Mental State Exam
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn L. Turvey, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interpersonal Psychotherapy for Depression in People With Heart Failure
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