Reducing Depression in Dementia Caregivers

Depression Clinical Trial

Official title:

Reducing Depression in Dementia Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056316
• Other study ID #: R21MH061956
• Secondary ID: R21MH061956DSIR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2003
• Last updated: June 4, 2014
• Start date: January 2002
• Est. completion date: August 2004

Study information

• Verified date: June 2014
• Source: University of Missouri, St. Louis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
• 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.

Locations

Country	Name	City	State
United States	University of Missouri-St. Louis	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, St. Louis	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory II (Beck, Steer & Brown, 1996)	21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.	Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention	No
Primary	Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)	21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.	Post-intervention, assessed 4-14 days after final intervention session.	No
Secondary	Negative Affect Schedule (Watson, Clark & Tellegen, 1988)	10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.	Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention	No
Secondary	Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)	10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.	Post-intervention, assessed 4-14 days after final intervention session.	No