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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 14, 2006 | ||||||||
| Last Updated Date | July 24, 2009 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Score on the 17-item HRSD [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Measured at Week 16: Score on the 17-item HRSD | ||||||||
| Change History | Complete list of historical versions of study NCT00353223 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Interpersonal Psychotherapy for Depression in People With Heart Failure | ||||||||
| Official Title ICMJE | Interpersonal Psychotherapy for Depression in Patients With Heart Failure | ||||||||
| Brief Summary | This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral activation techniques in treating depression in people with congestive heart failure. |
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| 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. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 87 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 55 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00353223 | ||||||||
| Responsible Party | Carolyn Turvey, University of Iowa | ||||||||
| Study ID Numbers ICMJE | R34 MH073566, DATR A4-GPS | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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