Life Enhancing Activities for Family Caregivers (LEAF)
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|ClinicalTrials.gov Identifier: NCT01825681|
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : August 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Crossover Assignment|
|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|
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
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825681
|United States, California|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Glenna A Dowling, PhD||University of California, San Francisco|