Stress Reduction Study for Partners of Early Stage Dementia

NCT ID: NCT03691428

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2021-06-30

Brief Summary

This is a study designed to pilot a WOOP (Wish Outcome Obstacle Plan) intervention for spouses of persons with early stage dementia for the purposes of future research. The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Spouses of persons with dementia will use WOOP, a brief goal attainment sequence, every day for 16 days. Participants will complete surveys before the intervention, at Day 16, and at a 3-month follow-up. The outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. As of 9/2020 this entire study is being conducted remotely.

Conditions

Dementia Caregiving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Wish Outcome Obstacle Plan

Intervention Type: BEHAVIORAL

1\. Wish or goal: A wish (e.g. "responding calmly when the partner asks a question repeatedly"). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. "both partners feel respected and happy"). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., "feeling impatient"). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., "take a deep breath, take my partner's perspective, and answer the question calmly"); then he or she forms an "if" \[specified obstacle - when I feel impatient\], "then I will" \[specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly\] plan.

Wait-list

Participants will get the WOOP training after the last outcome assessment.

Group Type: OTHER

Wish Outcome Obstacle Plan

Intervention Type: BEHAVIORAL

1\. Wish or goal: A wish (e.g. "responding calmly when the partner asks a question repeatedly"). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. "both partners feel respected and happy"). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., "feeling impatient"). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., "take a deep breath, take my partner's perspective, and answer the question calmly"); then he or she forms an "if" \[specified obstacle - when I feel impatient\], "then I will" \[specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly\] plan.

Interventions

Wish Outcome Obstacle Plan

1\. Wish or goal: A wish (e.g. "responding calmly when the partner asks a question repeatedly"). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. "both partners feel respected and happy"). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., "feeling impatient"). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., "take a deep breath, take my partner's perspective, and answer the question calmly"); then he or she forms an "if" \[specified obstacle - when I feel impatient\], "then I will" \[specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly\] plan.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

• The couple is married or in a cohabiting, committed relationship.
• One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination (MMSE) ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤1923. Or>20 on Telephone Interview for Cognitive Status. (TICS)
• The spouse will have to score 27 or higher on the MMSE. Or>25 on TICS.
• Both participants must agree to participate and complete baseline interviews.
• Both partners are at least 60 years old.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Joan Monin

New Haven, Connecticut, United States

Countries

United States

References

Monin JK, Oettingen G, Laws H, David D, DeMatteo L, Marottoli R. A Controlled Pilot Study of the Wish Outcome Obstacle Plan Strategy for Spouses of Persons With Early-Stage Dementia. J Gerontol B Psychol Sci Soc Sci. 2022 Mar 3;77(3):513-524. doi: 10.1093/geronb/gbab115.

Reference Type: DERIVED

PMID: 34171086 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AG055861-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000021852

Identifier Type: -

Identifier Source: org_study_id