450 Participants NeededMy employer runs this trial

Group Interventions for Dementia Caregiver Stress

(LIGHTEN Trial)

LS
Overseen ByLIGHTEN Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two programs designed to help caregivers of people with memory loss manage stress more effectively. The goal is to determine whether Caring Together or Savvy Caregiver better reduces stress, improves coping skills, and boosts confidence in caregiving. Caregivers who feel overwhelmed and currently care for someone with memory problems at home might be suitable for this study. Participants will join one of the programs through telehealth and provide feedback at the start, after seven weeks, and again at six months. As an unphased trial, this study offers caregivers a unique opportunity to contribute to research that could enhance support systems for those managing memory loss.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Caring Together and Savvy Caregiver programs are safe for participants. These programs aim to reduce stress and improve the coping skills of caregivers for people with memory issues.

For Caring Together, studies indicate it is well-received because it helps caregivers manage stress and negative feelings. It uses cognitive-behavioral therapy, a common method to help people change negative thoughts and behaviors.

The Savvy Caregiver program provides strategies to handle daily challenges and boost caregiver confidence. This program teaches practical problem-solving skills and helps caregivers understand dementia symptoms.

Neither program involves medication or invasive procedures, which lowers the risk of physical side effects. While specific data on negative effects for these programs is lacking, their focus on education and support suggests a low risk for participants.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for caregiver stress related to dementia because they offer a unique, group-based approach that focuses on both emotional resilience and practical problem-solving. Unlike traditional support that might focus solely on emotional counseling, Caring Together uses cognitive-behavioral therapy to help caregivers build coping skills and manage difficult emotions, aiming to reduce stress and enhance self-care. On the other hand, Savvy Caregiver emphasizes understanding dementia symptoms and structuring daily routines, offering practical strategies to handle day-to-day challenges. Both programs aim to boost caregivers' confidence and well-being, providing a supportive community to share experiences and solutions.

What evidence suggests that this trial's treatments could be effective for reducing caregiver stress?

Research has shown that the "Caring Together" program, available to participants in this trial, uses cognitive-behavioral therapy to effectively reduce stress and depression in caregivers. One study found a 52% reduction in stress and a 38% decrease in depression. This program teaches caregivers how to cope better, manage stress, and care for themselves. Meanwhile, evidence supports the "Savvy Caregiver" program, another trial option, in reducing personal stress and improving caregivers' outlook. It provides practical tips and information about dementia, boosting caregivers' confidence and reducing feelings of being overwhelmed. Both programs positively impact caregivers' well-being and help them manage stress.36789

Who Is on the Research Team?

EP

Evan Plys, PhD

Principal Investigator

Massachusetts General Hospital

AV

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults who are caregivers of people with memory loss or dementia. Participants should be experiencing stress related to caregiving and able to join group sessions online. Specific inclusion and exclusion criteria are not detailed.

Inclusion Criteria

My caregiver is at least 18 years old.
Caregiver Zarit Burden Interview-6 (ZBI-6) score greater than or equal to 9
Care recipient currently living in community
See 3 more

Exclusion Criteria

Severe, untreated mental illness or substance use (self or clinician report)
Care recipient enrolled or planning to enroll in hospice
Active suicide risk
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of two group-based telehealth programs (Caring Together or Savvy Caregiver) and participate in weekly 120-minute virtual group sessions over 6 weeks.

6 weeks
6 virtual group sessions

Follow-up

Participants complete self-reported assessments to evaluate the maintenance of improvements over a 6-month period.

6 months
Post-intervention assessment and 6-month follow-up survey

What Are the Treatments Tested in This Trial?

Interventions

  • Caring Together
  • Savvy Caregiver

Trial Overview

The study compares two telehealth group programs, Savvy Caregiver and Caring Together, designed to help dementia caregivers manage stress, improve coping skills, and boost confidence. Participants are randomly assigned to one program.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Caring TogetherActive Control1 Intervention
Group II: Savvy CaregiverActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Tufts Medical Center

Collaborator

Trials
264
Recruited
264,000+

Citations

Effectiveness of Powerful Tools for Caregivers on ... - PMC

We found that PTC was associated with 52% and 38% net improvements on caregiver burden and depressive symptoms. By comparison, a multicomponent intervention in ...

The effects of self-guided interventions on stress, burden ...

Self-guided interventions have potential benefits in reducing stress of unpaid caregivers of people living with dementia, but there are conflicting results ...

5 Programs and Supports for Family Caregivers of Older ...

Family caregiver outcomes included preparedness to care for survivor, burden, stress and strain, anxiety, depression, quality of life, social functioning, ...

Research on Supportive Approaches for Family and Other ...

This paper examines how caring for a person with dementia affects the caregiver and what is known about effective ways to support caregivers, ...

The 2024 Facts & Figures report also shows the latest ...

70% of dementia caregivers report that coordinating care is stressful. A majority of caregivers (70%) report that coordination of care is ...

Exploring the Relationship between the Caregiver's Stress ...

The aim of this study was to explore the relationship between caregivers' stress loads and dementia patient behavior, including the correlation ...

Caregiver Health

Estimates show that between 40 to 70% of caregivers have clinically significant symptoms of depression, with approximately one quarter to one half of these ...

Caring Together:

By strengthening early symptom recognition, they can support caregivers over the long term, promote timely intervention, improve outcomes, and reinforce.

Caregiver outcomes of a dementia care program

While the majority of PLWD and caregiver participants in the. UCLA ADC had improvement in neuropsychiatric symptoms or their caregivers had reduced strain, ...