NCT00056316

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Jan 2002

Typical duration for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 19, 2008

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2.6 years

First QC Date

March 10, 2003

Results QC Date

October 23, 2008

Last Update Submit

June 4, 2014

Conditions

Keywords

CaregivingDementiaAlzheimer'sDepressionTechnologyTreatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Secondary Outcomes (2)

  • Negative Affect Schedule (Watson, Clark & Tellegen, 1988)

    Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention

  • Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)

    Post-intervention, assessed 4-14 days after final intervention session.

Study Arms (2)

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.

Behavioral: Behavioral Skills Training: Experimental

Basic Education

ACTIVE COMPARATOR

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

Behavioral: Basic Education

Interventions

Basic EducationBEHAVIORAL

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

Basic Education

Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.

Behavioral Skills Training

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver and dementia pt live in the same home
  • Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI

You may not qualify if:

  • Insulin dependent diabetes
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-St. Louis

St Louis, Missouri, 63121, United States

Location

Related Publications (3)

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

    BACKGROUND
  • 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.

    PMID: 11773226BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionDementia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Ann M. Steffen, PhD, Associate Professor
Organization
University of Missouri-St. Louis

Study Officials

  • Ann M. Steffen, PhD

    University of Missouri, St. Louis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2003

First Posted

March 11, 2003

Study Start

January 1, 2002

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

June 23, 2014

Results First Posted

November 19, 2008

Record last verified: 2014-06

Locations