Reducing Depression in Dementia Caregivers

This study has been completed.

Study NCT00056316 Information provided by National Institute of Mental Health (NIMH)

First Received: March 10, 2003 Last Updated: November 17, 2008 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Condition:	Depression
Interventions:	Behavioral: Basic Education Behavioral: Behavioral Skills Training: Experimental

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place from 10/2001 to 3/2004. Project information was distributed to Alzheimers Association Chapters and Area Agencies on Aging (AAA's) in Midwestern USA (IO, IL,IN, KS, MI, MO, MN, NB,WI).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants who completed consent procedures were randomly assigned to groups.

Reporting Groups

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

Participant Flow: Overall Study

[1]	over-enrolled due to potential higher rates of drop-out.

Baseline Characteristics

Reporting Groups

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

Baseline Measures

	Behavioral Skills Training	Basic Education	Total
Number of Participants [units: participants]	33	41	74
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	23	26	49
>=65 years	10	15	25
Age [units: years] Mean ± Standard Deviation	58.4 ± 11.9	62.9 ± 9.6	61.1 ± 11.1
Gender [units: participants]
Female	33	41	74
Male	0	0	0
Region of Enrollment [units: participants]
United States	33	41	74

Outcome Measures

1. Primary:

Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ]

Show Outcome Measure 1

2. Primary:

Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Post-intervention, assessed 4-14 days after final intervention session. ]

Show Outcome Measure 2

3. Secondary:

Negative Affect Schedule (Watson, Clark & Tellegen, 1988) [ Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ]

Show Outcome Measure 3

4. Secondary:

Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) [ Post-intervention, assessed 4-14 days after final intervention session. ]

Show Outcome Measure 4