LEAF: Life Enhancing Activities for Family Caregivers

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01825681

Collaborator

(none)

175

Enrollment

Location

Arms

68.9

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Oct 1, 2013

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Jun 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 Names: Life Enhancing Activities for Family Caregivers (LEAF)
No Intervention: wait list control wait list control

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 Names:

Life Enhancing Activities for Family Caregivers (LEAF)

No Intervention: wait list control

wait list control

Outcome Measures

Primary Outcome Measures

Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977) [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

Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980) [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.
Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988) [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.
Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983) [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.
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) [Baseline and weeks 6 and 10; 3-months and 6-months post]
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) [Baseline and weeks 6 and 10; 3-months and 6-months post]
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) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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