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Completed

NCT Number: NCT01825681

Life Enhancing Activities for Family Caregivers

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.

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Key information

Conditions

Stress Affect Behavior Brain Diseases Central Nervous System Diseases Dementia Helping Behavior Mental Disorders Nervous System Diseases Neurocognitive Disorders Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive affect

Behavioral

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Life Enhancing Activities for Family Caregivers (LEAF)

Acronym: LEAF

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Apr 8, 2013
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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