Clinical trial NCT00353223: Interpersonal Psychotherapy for Depression in People With Heart Failure
Official title: Interpersonal Psychotherapy for Depression in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Heart Failure, Congestive
Keywords: Heart Failure
Functional Impairment
Health-Related Quality of Life
Telemedicine
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-18
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Score on the 17-item HRSD
timeFrame: Measured at Week 12
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Measured at Week 12
measure: Interpersonal functioning
timeFrame: Measured at Week 12
measure: Behavioral activation
timeFrame: Measured at Week 12
measure: Self care of heart failure
timeFrame: Measured at Week 12
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Carolyn L. Turvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: