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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH061956 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-GS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
Family caregivers of individuals with dementia commonly report depressive symptoms, along with other forms of emotional distress. This study compared the effectiveness of two home-based interventions to reduce levels of depressed, anxious, and other negative moods in women living with a family member with dementia. Eligible caregivers were randomly assigned to participate in either a video/workbook/telephone coaching intervention, or to a basic education condition consisting of a workbook and supportive telephone calls. Participants were evaluated for psychosocial distress after treatment, and at 3- and 6-months following the end of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Basic Education | Active Comparator | Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic Education | Behavioral | Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Affect Schedule (Watson, Clark & Tellegen, 1988) | 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. | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann M. Steffen, PhD | University of Missouri, St. Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-St. Louis | St Louis | Missouri | 63121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000. | ||
| 11773226 | 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. | |
| 33417236 |
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All enrolled participants who completed consent procedures were randomly assigned to groups.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Basic Education | Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Basic Education |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants | Posted | Mean | Standard Deviation | Points on a scale | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann M. Steffen, PhD, Associate Professor | University of Missouri-St. Louis | 314-516-5382 | ann_steffen@umsl.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Behavioral Skills Training: Experimental | Behavioral | Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions. |
|
| Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) | 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. | Post-intervention, assessed 4-14 days after final intervention session. |
| Derived |
| 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. |
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. |
|
|
| Secondary | Negative Affect Schedule (Watson, Clark & Tellegen, 1988) | 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. | 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. | Posted | Mean | Standard Deviation | Points on a scale | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Points on a scale | Post-intervention, assessed 4-14 days after final intervention session. |
|
|
|
|
| Secondary | Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) | 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. | 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. | Posted | Mean | Standard Deviation | Points on a scale | Post-intervention, assessed 4-14 days after final intervention session. |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Basic Education | Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. | 0 | 0 | 0 | 0 |
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| D009422 |
| Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |