Clinical trial NCT01825681: Life Enhancing Activities for Family Caregivers
Official title: Life Enhancing Activities for Family Caregivers (LEAF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Dementia
Affect
Keywords: positive affect
caregivers
caregiving
stress
mood
dementia
Alzheimer's
FTD
Lewy
mindfulness
help
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
Secondary outcomes:
measure: Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
measure: Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
measure: Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
measure: 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)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
measure: 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)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
measure: Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)
timeFrame: Baseline and weeks 6 and 10; 3-months and 6-months post
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Glenna A Dowling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.