| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Interpersonal Psychotherapy for Depression in People With Heart Failure | ||||||||
| Official Title † | 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. |
||||||||
| 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 8 and 16. 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 8 and 16. 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. |
||||||||
| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Score on the 17-item HRSD [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] |
||||||||
| Condition † | Depression Heart Failure, Congestive |
||||||||
| Intervention † | Behavioral: Interpersonal and behavioral psychotherapy Behavioral: Attention control (AC) condition |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 87 | ||||||||
| Start Date † | July 2006 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 55 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00353223 | ||||||||
| Organization ID | R34 MH73566 | ||||||||
| Secondary IDs †† | DATR A4-GPS | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | July 14, 2006 | ||||||||
| Last Updated Date | March 24, 2008 | ||||||||
|
