| March 10, 2003 |
| November 17, 2008 |
| January 2002 |
| August 2004 (final data collection date for primary outcome measure) |
- 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 ]
|
| Same as current |
| Complete list of historical versions of study NCT00056316 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Reducing Depression in Dementia Caregivers |
| Reducing Depression in Dementia Caregivers |
This study will identify effective treatments for reducing depression among female caregivers to patients with dementia. |
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. |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Depression |
- Behavioral: Basic Education
- Behavioral: Behavioral Skills Training: Experimental
|
- 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: Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
|
| Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. |
| |
| Completed |
| 74 |
| August 2004 |
| August 2004 (final data collection date for primary outcome measure) |
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
|
| Female |
| 50 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00056316 |
| Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis |
| R21 MH61956, DSIR AT-GS |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Ann M. Steffen, Ph.D. |
University of Missouri-St. Louis |
|
|
| National Institute of Mental Health (NIMH) |
| November 2008 |
