Reducing Depression in Dementia Caregivers - Study Results

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

	Behavioral Skills Training	Basic Education
STARTED	33	41^[1]
COMPLETED	30	38
NOT COMPLETED	3	3
Withdrawal by Subject	2	2
Death/NH placement of pt	1	1

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

Baseline Characteristics

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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

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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Measure Type	Secondary
Measure Title	Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
Measure Description	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.
Time Frame	Post-intervention, assessed 4-14 days after final intervention session.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.

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.

Measured Values

	Behavioral Skills Training	Basic Education
Number of Participants Analyzed [units: participants]	33	41
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) [units: points on a scale] Mean ± Standard Deviation	18.52 ± 5.66	21.63 ± 6.99

Statistical Analysis 1 for Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	.05
Mean Difference (Final Values) ^[4]	2.07

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
	Mean difference = Behavioral Skills Intervention minus Basic Education Control

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Ann M. Steffen, PhD, Associate Professor
Organization: University of Missouri-St. Louis
phone: 314-516-5382
e-mail: ann_steffen@umsl.edu

Publications:

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

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.

Responsible Party:	University of Missouri-St. Louis ( Ann M. Steffen, Ph.D./Associate Professor of Psychology )
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
ClinicalTrials.gov Identifier:	NCT00056316 History of Changes
Health Authority:	United States: Federal Government