Life Enhancing Activities for Family Caregivers (LEAF)

• ClinicalTrials.gov Identifier: NCT01825681
• Recruitment Status: Completed
• First Posted: April 8, 2013
• Last Update Posted: August 5, 2019
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Glenna Dowling, University of California, San Francisco

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.

Condition or disease	Intervention/treatment	Phase
Stress; Dementia; Affect	Behavioral: Positive Affect	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Life Enhancing Activities for Family Caregivers (LEAF)
• Study Start Date: October 2013
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: positive affect intervention; positive affect intervention	Behavioral: Positive Affect; Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.; Other Name: Life Enhancing Activities for Family Caregivers (LEAF)
No Intervention: wait list control; wait list control

Outcome Measures

Primary Outcome Measures :

1. Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   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 :

1. Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   22-item inventory assesses caregivers' subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status.
2. Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   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.
3. Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   The CSI is a 13-item measure of both objective and subjective elements of caregiver strain.
4. 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) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   Used to assess depressive mood.
5. 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) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   Used to assess anxiety.
6. Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987) [ Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

UCSF

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Glenna A Dowling, PhD; University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Glenna Dowling, Professor and chair, Department of Physiological Nursing, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01825681
• Other Study ID Numbers: 14-13236; A115168 ( Other Grant/Funding Number: Atlantic Philanthropies )
• First Posted: April 8, 2013
• Last Update Posted: August 5, 2019
• Last Verified: August 2019

Keywords provided by Glenna Dowling, University of California, San Francisco:

positive affect; caregivers; caregiving; stress; mood; dementia; Alzheimer's; FTD; Lewy; mindfulness; help

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders