NCT07764185

Brief Summary

This project will evaluate the effectiveness of the Recharge Behavioral Therapy (RBT) intervention to alleviate stress and depressive symptoms of caregivers of Individuals with Alzheimer's Disease and Related Dementia.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
9mo left

Started Aug 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 24, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Center for Epidemiological Studies Depression Scale

    The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.

    3 months

  • Perceived Stress Scale

    The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.

    3 months

Study Arms (2)

Caring Recharge mobile app

EXPERIMENTAL

Participants will receive the Caring Recharge mobile app containing the Recharge Behavioral Therapy program.

Behavioral: Recharge Behavioral Therapy

Traditional educational program

ACTIVE COMPARATOR

Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.

Behavioral: Traditional Educational/Resources Program

Interventions

Participants will receive the Caring Recharge mobile app containing the Recharge Behavioral Therapy.

Caring Recharge mobile app

Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.

Traditional educational program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Care for an individual with Alzheimer s Disease or other dementia.
  • Have a Smartphone or tablet with Internet access.
  • Minimum age of 18 years old.
  • Spend at least 8 hours/week caring for a person with dementia.

You may not qualify if:

  • Severe psychological or physical illness.
  • Inability to read and follow instructions.
  • Unwillingness to participate in all aspects of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Bruno Kajiyama

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share