Evaluation of an App to Alleviate Stress Among Caregivers of People With Dementia

NCT06203639 | Completed

• 1 other identifier: 2022-069
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. The goal of our study is to test a newly developed app that focuses on providing stress management strategies for caregivers of people living with dementia.

Conditions

Caregiver Burden

Keywords

Dementia; mobile app

Outcome Measures

Primary Outcomes (12)

• Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-weeks

  Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress

  The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up

  Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress

  The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period

• Change from after the 8-week period in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up

  Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress

  The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period

• Change from baseline in the Burden Scale for Family Caregivers-Short Version (BSFC-S) total scores at 8-weeks

  Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden

  The BSFC-S will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the BSFC-S total scores at a 4-week follow-up

  Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden

  The BSFC-S will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up

• Change from after the 8-week period in the BSFC-S total scores at a 4-week follow-up

  Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden

  The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period

• Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total scores at 8-weeks

  The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.

  The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the PHQ-9 total scores at a 4-week follow-up

  The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.

  The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period

• Change from after the 8-week period in the PHQ-9 total scores at a 4-week follow-up

  The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.

  The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period

• Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total scores at 8-weeks

  The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.

  The GAD-7 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the GAD-7 total scores at a 4-week follow-up

  The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.

  The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period

• Change from after the 8-week period in the GAD-7 total scores at a 4-week follow-up

  The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.

  The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period

Secondary Outcomes (9)

• Change from baseline in the Multidimensional Scale for Perceived Social Support (MSPSS) total scores at 8-weeks

  The MSPSS will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the MSPSS total scores at a 4-week follow-up

  The MSPSS will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period

• Change from after the 8-week period in the MSPSS total scores at a 4-week follow-up

  The MSPSS will be administered immediately after the 8-week period and at a 4-week follow-up period

• Change from baseline in the Caregiving Self-Efficacy Scale (CSES-8) total scores at 8-weeks

  The CSES-8 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)

• Change from baseline in the CSES-8 total scores at a 4-week follow-up

  The CSES-8 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period

Study Arms (3)

UR Caregiver group

EXPERIMENTAL

Participants will be asked to use the UR Caregiver app daily (e.g., at least 15 minutes/day) for 8 weeks and complete and practice one module per week. On the eighth week, participants will be asked to review one of the past modules of their choice.

Other: UR Caregiver

Active control

ACTIVE COMPARATOR

Participants will be asked to use the app daily (e.g., at least 15 minutes/day) for an 8-week period.

Other: CLEAR Dementia Care

Non-app using control

NO INTERVENTION

Participants in this group will not be using any apps in the study.

Interventions

UR Caregiver OTHER

The UR Caregiver app was informed by previous research and developed in collaboration with caregiver partners. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. The app consists of seven modules. The app is available on IOS and Googe Play store. In addition to the didactic information provided in the app, worksheets are available in each module to practice the strategy/skill provided.

UR Caregiver group

CLEAR Dementia Care OTHER

A subset of participants will be randomly assigned to use the CLEAR Dementia Care app as part of an active control group. The app consists of features that primarily address care-related needs (as opposed to stress management strategies) allowing for a comparison with the UR Caregiver app. The app was developed by the Northern Health and Social Care Trust (Northern Ireland) and is freely available on both IOS and Google Play stores. The CLEAR Dementia Care app provides users with information about dementia (e.g., the different types of dementia, how dementia affects the brain, and symptoms associated with dementia). The app offers suggestions and alternative approaches to various care-related situations through illustrations/images that caregivers may experience.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia
• providing primary care (i.e., most of the care or equally shares the care with another individual such as a mother or sibling) for the person living with dementia
• own a smartphone/tablet (i.e., can access either IOS or Android platforms).

You may not qualify if:

• \) Currently using an app for caregiver stress/burden

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (6)

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014 Feb 20;14:23. doi: 10.1186/1471-2318-14-23.

  PMID: 24555474 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.

  PMID: 33146727 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Thomas Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of the three group conditions: 1) UR Caregiver; 2) active control group; and 2) control group.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: January 10, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available to other researchers, following the publication of the results, upon reasonable request for a period of at least 7 years.
• Access Criteria: Requests by researchers who wish to access the data can be directed to Thomas.Hadjistavropoulos@uregina.ca

Locations

CA (1)