Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353223
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2006-07-14
Brief Title:
Interpersonal Psychotherapy for Depression in People With Heart Failure
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
Interpersonal Psychotherapy for Depression in Patients With Heart Failure
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A4-GPS | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH073566 |
| R34MH073566 | NIH | None | None |