Interpersonal Psychotherapy for Depression in People With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00353223
First received: July 14, 2006
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral activation techniques in treating depression in people with congestive heart failure.


Condition Intervention Phase
Depression
Heart Failure, Congestive
Behavioral: Interpersonal and behavioral psychotherapy
Behavioral: Attention control (AC) condition
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interpersonal Psychotherapy for Depression in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Score on the 17-item HRSD [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Interpersonal functioning [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Behavioral activation [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Self care of heart failure [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: July 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive combined interpersonal and behavioral psychotherapy aimed at reducing depression in patients with heart failure.
Behavioral: Interpersonal and behavioral psychotherapy
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.
Active Comparator: B
Participants will receive the attention control condition.
Behavioral: Attention control (AC) condition
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353223

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Carolyn L. Turvey, PhD University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00353223     History of Changes
Other Study ID Numbers: R34 MH073566, R34MH073566, DATR A4-GPS
Study First Received: July 14, 2006
Last Updated: May 30, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Heart Failure
Functional Impairment
Health-Related Quality of Life
Telemedicine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014