Reducing Depression in Dementia Caregivers
This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00056316
First received: March 10, 2003
Last updated: November 17, 2008
Last verified: November 2008
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Purpose
This study will identify effective treatments for reducing depression among female caregivers to patients with dementia.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Basic Education Behavioral: Behavioral Skills Training: Experimental |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reducing Depression in Dementia Caregivers |
Resource links provided by NLM:
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome Measures:
- Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Time Frame: Post-intervention, assessed 4-14 days after final intervention session. ] [ Designated as safety issue: No ]
- Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Negative Affect Schedule (Watson, Clark & Tellegen, 1988) [ Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ] [ Designated as safety issue: No ]
- Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) [ Time Frame: Post-intervention, assessed 4-14 days after final intervention session. ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | January 2002 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Behavioral Skills Training
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
|
Behavioral: Behavioral Skills Training: Experimental
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
|
|
Active Comparator: Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
|
Behavioral: Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
|
Detailed Description:
Caregivers to patients with dementia often experience some level of depression. This study will compare the effectiveness of two home based information and support treatments to reduce depressive episodes.
This study is for women who live with a family member with dementia and are experiencing stress related to caregiving. Caregivers are randomly assigned to either a psychoeducational intervention or to treatment as usual for 10 weeks. The psychoeducational group members receive written and videotaped material and weekly telephone contact with a mental health professional. After treatment, participants are evaluated for psychological distress. Participants are reassessed after 6 months.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Caregiver and dementia pt live in the same home
- Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI
Exclusion Criteria:
- Insulin dependent diabetes
- Thyroid disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056316
Locations
| United States, Missouri | |
| University of Missouri-St. Louis | |
| St. Louis, Missouri, United States, 63121 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Ann M. Steffen, Ph.D. | University of Missouri, St. Louis |
More Information
Publications:
Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.
| Responsible Party: | Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis |
| ClinicalTrials.gov Identifier: | NCT00056316 History of Changes |
| Other Study ID Numbers: | R21 MH61956, DSIR AT-GS |
| Study First Received: | March 10, 2003 |
| Results First Received: | October 23, 2008 |
| Last Updated: | November 17, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Dementia |
Additional relevant MeSH terms:
|
Dementia Depression Depressive Disorder Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 23, 2013