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Reducing Depression in Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00056316
Recruitment Status : Completed
First Posted : March 11, 2003
Results First Posted : November 19, 2008
Last Update Posted : June 23, 2014
Sponsor:
Collaborator:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
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

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.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
   Behavioral Skills Training   Basic Education   Total 
Overall Participants Analyzed 
[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)   [ Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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.


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.


Responsible Party: Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis
ClinicalTrials.gov Identifier: NCT00056316     History of Changes
Other Study ID Numbers: R21MH061956 ( U.S. NIH Grant/Contract )
DSIR AT-GS
First Submitted: March 10, 2003
First Posted: March 11, 2003
Results First Submitted: October 23, 2008
Results First Posted: November 19, 2008
Last Update Posted: June 23, 2014