Back to resultsLife Enhancing Activities for Family Caregivers (LEAF)
Primary Purpose
Stress, Dementia, Affect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Affect
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring positive affect, caregivers, caregiving, stress, mood, dementia, Alzheimer's, FTD, Lewy, mindfulness, help
Eligibility Criteria
Inclusion Criteria:
- Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)
- Must speak and read English
- Must have the ability to provide informed consent
Exclusion Criteria:
- Lack of access to a high speed internet connection
- Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers
Sites / Locations
- UCSF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
positive affect intervention
wait list control
Arm Description
positive affect intervention
wait list control
Outcomes
Primary Outcome Measures
Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
The DES will be used to assess positive and negative affect. This 20-item version of the DES was modified to include additional positive affect items as well as those that are likely to tap into trait positive affectivity. The full scale assesses interest, enjoyment, surprise, sadness, anger, disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment, gratitude, hope, love, pride, sympathy, and sexual feelings (e.g., "I felt sexual, desiring, and flirtatious"). The scale can be scored for total positive and negative affect,grouped according to where they would fall on the circumplex model of affect (e.g., high activation vs. lower activation),or individual affects can be examined. In student samples this modified DES has shown acceptable reliability with the positive affects subscale (α = .79) and the negative affects subscale (α = .69).
Secondary Outcome Measures
Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)
22-item inventory assesses caregivers' subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status.
Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)
The 10 items are designed to identify how unpredictable, uncontrollable and overloaded respondents find their lives. Scores range from 0-40, with higher scores indicating greater stress.
Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)
The CSI is a 13-item measure of both objective and subjective elements of caregiver strain.
Change in depression at end of intervention, 3 and 6-months post - Depression, Patient Reported Outcomes Measurement Information System Item Bank, v. 1.0 (PROMIS; Cella et al., 2010)
Used to assess depressive mood.
Change in anxiety at end of intervention, 3 and 6-months post - Emotional Distress - Anxiety, PROMIS Item Bank v. 1.0 (Cella et al., 2010)
Used to assess anxiety.
Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)
The 23 forms of coping responses assessed include: confrontive coping, escape-avoidance, planful problem-solving, positive reappraisal, benefit, growth, mastery of stress, other success, purpose, positive relations with others, religion, and respite, benevolent and negative religious coping, emotional processing and expression, goal replacement, and maintaining optimism.
Full Information
NCT ID
NCT01825681
First Posted
March 25, 2013
Last Updated
August 1, 2019
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01825681
Brief Title
Life Enhancing Activities for Family Caregivers
Acronym
LEAF
Official Title
Life Enhancing Activities for Family Caregivers (LEAF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.
Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.
Detailed Description
All study activities can be conducted from the participant's home, making participation possible for any qualified caregiver with computer and wifi access, in any U.S. state. The LEAF study will supply the tablet computer, software, and workbook required for participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Dementia, Affect
Keywords
positive affect, caregivers, caregiving, stress, mood, dementia, Alzheimer's, FTD, Lewy, mindfulness, help
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
positive affect intervention
Arm Type
Experimental
Arm Description
positive affect intervention
Arm Title
wait list control
Arm Type
No Intervention
Arm Description
wait list control
Intervention Type
Behavioral
Intervention Name(s)
Positive Affect
Other Intervention Name(s)
Life Enhancing Activities for Family Caregivers (LEAF)
Intervention Description
Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.
Primary Outcome Measure Information:
Title
Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
Description
The DES will be used to assess positive and negative affect. This 20-item version of the DES was modified to include additional positive affect items as well as those that are likely to tap into trait positive affectivity. The full scale assesses interest, enjoyment, surprise, sadness, anger, disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment, gratitude, hope, love, pride, sympathy, and sexual feelings (e.g., "I felt sexual, desiring, and flirtatious"). The scale can be scored for total positive and negative affect,grouped according to where they would fall on the circumplex model of affect (e.g., high activation vs. lower activation),or individual affects can be examined. In student samples this modified DES has shown acceptable reliability with the positive affects subscale (α = .79) and the negative affects subscale (α = .69).
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary Outcome Measure Information:
Title
Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)
Description
22-item inventory assesses caregivers' subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Title
Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)
Description
The 10 items are designed to identify how unpredictable, uncontrollable and overloaded respondents find their lives. Scores range from 0-40, with higher scores indicating greater stress.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Title
Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)
Description
The CSI is a 13-item measure of both objective and subjective elements of caregiver strain.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Title
Change in depression at end of intervention, 3 and 6-months post - Depression, Patient Reported Outcomes Measurement Information System Item Bank, v. 1.0 (PROMIS; Cella et al., 2010)
Description
Used to assess depressive mood.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Title
Change in anxiety at end of intervention, 3 and 6-months post - Emotional Distress - Anxiety, PROMIS Item Bank v. 1.0 (Cella et al., 2010)
Description
Used to assess anxiety.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
Title
Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)
Description
The 23 forms of coping responses assessed include: confrontive coping, escape-avoidance, planful problem-solving, positive reappraisal, benefit, growth, mastery of stress, other success, purpose, positive relations with others, religion, and respite, benevolent and negative religious coping, emotional processing and expression, goal replacement, and maintaining optimism.
Time Frame
Baseline and weeks 6 and 10; 3-months and 6-months post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)
Must speak and read English
Must have the ability to provide informed consent
Exclusion Criteria:
Lack of access to a high speed internet connection
Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenna A Dowling, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31045422
Citation
Moskowitz JT, Cheung EO, Snowberg KE, Verstaen A, Merrilees J, Salsman JM, Dowling GA. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019 May;38(5):391-402. doi: 10.1037/hea0000680.
Results Reference
derived
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Life Enhancing Activities for Family Caregivers
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