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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
Sponsor:
Information provided by (Responsible Party):
Glenna Dowling, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 25, 2013
First Posted Date  ICMJE April 8, 2013
Last Update Posted Date August 5, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
repeated measures of the modified version of the Differential Emotions Scale(DES) (Izard 1977) [ Time Frame: baseline and weeks 6, 10 and for some participants also weeks ]
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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Life Enhancing Activities for Family Caregivers
Official Title  ICMJE Life Enhancing Activities for Family Caregivers (LEAF)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress
  • Dementia
  • Affect
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Experimental: positive affect intervention
    positive affect intervention
    Intervention: Behavioral: Positive Affect
  • No Intervention: wait list control
    wait list control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
175
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2013)
196
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01825681
Other Study ID Numbers  ICMJE 14-13236
A115168 ( Other Grant/Funding Number: Atlantic Philanthropies )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glenna Dowling, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glenna A Dowling, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP