Life Enhancing Activities for Family Caregivers

NCT01825681 | Completed

• 2 other identifiers: 14-13236A115168
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Dementia; Affect

Keywords

positive affect; caregivers; caregiving; stress; mood; dementia; Alzheimer's; FTD; Lewy; mindfulness; help

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline and weeks 6 and 10; 3-months and 6-months post

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

positive affect intervention

EXPERIMENTAL

positive affect intervention

Behavioral: Positive Affect

wait list control

NO INTERVENTION

wait list control

Interventions

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.

Also known as: Life Enhancing Activities for Family Caregivers (LEAF)

positive affect intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of access to a high speed internet connection
• Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 31045422 DERIVED

MeSH Terms

Conditions

Dementia; Helping Behavior

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Glenna A Dowling, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chair, Department of Physiological Nursing

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 8, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: June 30, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (1)