Depression
Conditions
Keywords
Caregiving, Dementia, Alzheimer's, Depression, Technology, Treatment
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).
Detailed description
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.
Interventions
BEHAVIORALBasic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
BEHAVIORALBehavioral 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Missouri, St. Louis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Caregiver and dementia pt live in the same home * Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI
Exclusion criteria
* Insulin dependent diabetes * Thyroid disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory II (Beck, Steer & Brown, 1996) | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention | 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. |
| Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) | Post-intervention, assessed 4-14 days after final intervention session. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Affect Schedule (Watson, Clark & Tellegen, 1988) | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention | 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. |
| Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) | Post-intervention, assessed 4-14 days after final intervention session. | 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. |
Countries
United States
Participant flow
Recruitment details
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
All enrolled participants who completed consent procedures were randomly assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Basic Education Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. | 41 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death/NH placement of pt | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Basic Education | Behavioral Skills Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 10 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 23 Participants | 49 Participants |
| Age, Continuous | 62.9 years STANDARD_DEVIATION 9.6 | 58.4 years STANDARD_DEVIATION 11.9 | 61.1 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 41 participants | 33 participants | 74 participants |
| Sex: Female, Male Female | 41 Participants | 33 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Population: All randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Skills Training | Beck Depression Inventory II (Beck, Steer & Brown, 1996) | 14.27 Points on a scale | Standard Deviation 8.07 |
| Basic Education | Beck Depression Inventory II (Beck, Steer & Brown, 1996) | 16.93 Points on a scale | Standard Deviation 8.46 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Skills Training | Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) | 10.25 Points on a scale | Standard Deviation 7.23 |
| Basic Education | Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) | 13.83 Points on a scale | Standard Deviation 8.36 |
p-value: 0.05t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Skills Training | Negative Affect Schedule (Watson, Clark & Tellegen, 1988) | 24.15 Points on a scale | Standard Deviation 6.72 |
| Basic Education | Negative Affect Schedule (Watson, Clark & Tellegen, 1988) | 24.17 Points on a scale | Standard Deviation 7.25 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Skills Training | Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) | 18.52 Points on a scale | Standard Deviation 5.66 |
| Basic Education | Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) | 21.63 Points on a scale | Standard Deviation 6.99 |
p-value: 0.05t-test, 2 sided