Clinical trial NCT00056316: Reducing Depression in Dementia Caregivers
Official title: Reducing Depression in Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Keywords: Caregiving
Dementia
Alzheimer's
Depression
Technology
Treatment
Lead sponsor: University of Missouri, St. Louis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-03-11
Enrollment: 74
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to develop and examine the initial impact of a distance-based intervention for female family dementia caregivers. As stated in the original proposal, the primary hypothesis of the study was that family caregivers who participated in the Video Intervention would show greater reduction in psychological distress (i.e., on measures of depression and emotional distress following problematic patient behaviors) compared to those in the Basic Education condition, and that this effect would be maintained over time (3 and 6 months post-tx).

Detailed description: Family caregivers of individuals with dementia commonly report depressive symptoms, along with other forms of emotional distress. This study compared the effectiveness of two home-based interventions to reduce levels of depressed, anxious, and other negative moods in women living with a family member with dementia. Eligible caregivers were randomly assigned to participate in either a video/workbook/telephone coaching intervention, or to a basic education condition consisting of a workbook and supportive telephone calls. Participants were evaluated for psychosocial distress after treatment, and at 3- and 6-months following the end of intervention.

Eligibility 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

Primary outcomes:
measure: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
timeFrame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
measure: Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
timeFrame: Post-intervention, assessed 4-14 days after final intervention session.
Secondary outcomes:
measure: Negative Affect Schedule (Watson, Clark & Tellegen, 1988)
timeFrame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
measure: Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
timeFrame: Post-intervention, assessed 4-14 days after final intervention session.
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: University of Missouri-St. Louis
state: Missouri
Study officials:
affiliation: University of Missouri, St. Louis
name: Ann M. Steffen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.
citation: 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. doi: 10.1093/geronb/57.1.p74.
citation: Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.