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Life Enhancing Activities for Family Caregivers (LEAF)

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ClinicalTrials.gov Identifier: NCT01825681
Recruitment Status : Active, not recruiting
First Posted : April 8, 2013
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Glenna Dowling, University of California, San Francisco

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.

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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
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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



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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Locations
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United States, California
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Glenna A Dowling, PhD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glenna Dowling, Professor and chair, Department of Physiological Nursing, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01825681     History of Changes
Other Study ID Numbers: 14-13236
A115168 ( Other Grant/Funding Number: Atlantic Philanthropies )
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

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