NCT07239609

Brief Summary

This project aims to implement and evaluate a dyadic intervention (i.e., acceptance commitment therapy) for persons with AD/ADRD and their care partners. We hypothesize the intervention will be feasible, acceptable, and show preliminary efficacy of the dyadic interveniotns.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Jan 2026

Typical duration for phase_1

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

Mild Cognitive ImparimentMild Neurocognitive DisorderDyadic intervention

Outcome Measures

Primary Outcomes (5)

  • Patient Health Questionnaire-9

    PHQ-9 is used to assess the presence and severity of depressive symptoms.

    6 weeks

  • Geriatric Depression Short From

    GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.

    6 Weeks

  • The Generalized Anxiety Disorder-7

    GAD-7 is used to assess the severity of generalized anxiety symptoms

    6 weeks

  • General Anxiety Scale-10

    The GAS-10 is designed to assess the severity of general anxiety symptoms

    6 Weeks

  • Pre-death grief-12

    The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.

    6 weeks

Secondary Outcomes (8)

  • Dyadic Coping Inventory

    6 Weeks

  • Short Form Health Survey (SF-12)

    6 Weeks

  • Purpose in Life Scale

    6 Weeks

  • Herth Hope Index

    6 Weeks

  • Inclusion of Other in the Self Scale

    6 Weeks

  • +3 more secondary outcomes

Study Arms (1)

Acceptance Commitment Therapy

EXPERIMENTAL

Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that aims to enhance psychological flexibility through six core processes: acceptance, cognitive defusion, being present, self-as-context, values clarification, and committed action. Rather than attempting to eliminate difficult thoughts and feelings, ACT encourages individuals to accept them while committing to behavior changes consistent with their personal values.

Behavioral: Acceptance Commitment Therapy

Interventions

Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that aims to enhance psychological flexibility through six core processes: acceptance, cognitive defusion, being present, self-as-context, values clarification, and committed action. Rather than attempting to eliminate difficult thoughts and feelings, ACT encourages individuals to accept them while committing to behavior changes consistent with their personal values.

Acceptance Commitment Therapy

Eligibility Criteria

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

You may qualify if:

  • MMSE= 21-27
  • Able to communicate in English
  • Identifies as a care partner of a person with MNCD
  • Able to communicate in English
  • MMSE= 28-30
  • Is a family member or friend of the person with MNCD

You may not qualify if:

  • Currently in an intervention for reducing anxiety or depression related to their dementia
  • MMSE= 28+ or less than 21
  • MMSE= \<28
  • Is a formal (paid) caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Generalized Anxiety DisorderNeurocognitive Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The investigators will not be providing any individual participant data. It will all be aggregate