Life Enhancing Activities for Family Caregivers

NCT ID: NCT01825681

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-06-30

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.

Conditions

Stress; Dementia; Affect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

positive affect intervention

positive affect intervention

Group Type: EXPERIMENTAL

Positive Affect

Intervention Type: BEHAVIORAL

Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.

wait list control

wait list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positive Affect

Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.

Intervention Type: BEHAVIORAL

Other Intervention Names

Life Enhancing Activities for Family Caregivers (LEAF)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Glenna Dowling

Professor and chair, Department of Physiological Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenna A Dowling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31045422 (View on PubMed)

Other Identifiers

A115168

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-13236

Identifier Type: -

Identifier Source: org_study_id