Trial Outcomes & Findings for Reducing Depression in Dementia Caregivers (NCT NCT00056316)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

74 participants

Primary outcome timeframe

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

Results posted on

2014-06-23

Participant Flow

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).

All enrolled participants who completed consent procedures were randomly assigned to groups.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	33	41
Overall Study COMPLETED	30	38
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2	2
Overall Study Death/NH placement of pt	1	1

Baseline Characteristics

Reducing Depression in Dementia Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Skills Training n=33 Participants Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.	Basic Education n=41 Participants Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 11.9 • n=5 Participants	62.9 years STANDARD_DEVIATION 9.6 • n=7 Participants	61.1 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	41 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	41 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

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

Population: All randomized participants

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.

Outcome measures

Outcome measures
Measure	Behavioral Skills Training n=33 Participants Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.	Basic Education n=41 Participants Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Beck Depression Inventory II (Beck, Steer & Brown, 1996)	14.27 Points on a scale Standard Deviation 8.07	16.93 Points on a scale Standard Deviation 8.46

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Behavioral Skills Training n=33 Participants Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.	Basic Education n=41 Participants Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)	10.25 Points on a scale Standard Deviation 7.23	13.83 Points on a scale Standard Deviation 8.36

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Behavioral Skills Training n=33 Participants Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.	Basic Education n=41 Participants Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Negative Affect Schedule (Watson, Clark & Tellegen, 1988)	24.15 Points on a scale Standard Deviation 6.72	24.17 Points on a scale Standard Deviation 7.25

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Behavioral Skills Training n=33 Participants Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.	Basic Education n=41 Participants Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)	18.52 Points on a scale Standard Deviation 5.66	21.63 Points on a scale Standard Deviation 6.99

Adverse Events

Behavioral Skills Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basic Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann M. Steffen, PhD, Associate Professor

University of Missouri-St. Louis

Phone: 314-516-5382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place