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

Not Applicable

Active, not recruiting

• Conditions: Caregiver Burden

• Registration Number: NCT06203639
• Lead Sponsor: University of Regina

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.

Detailed Description

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. Psychological interventions that focus on building skills and providing strategies to improve their well-being have been shown to improve caregiver well-being. Although mobile applications (apps) are available for caregivers of people living with dementia, existing apps do not adequately address the stress and mental health needs experienced by caregivers of people living with dementia. In addition, there is a paucity of mobile app interventions that provide practical stress management strategies for caregivers. The goal of the study is to conduct an evaluation of a novel app (UR Caregiver) that focuses on providing stress management strategies for caregivers of people living with dementia. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. Caregivers of people living with dementia will be recruited and randomly assigned to three groups: 1) UR Caregiver; 2) active control; and 3) non-app using control. Participants in the app-using groups will be asked to use the app over an 8-week period. Stress, burden, and mental health will be assessed before, after the 8-week period, and at a follow-up period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Given the demands that caregivers of people living with dementia face daily, the creation and evaluation of an app that aims to provide stress-management strategies has the potential of improving the quality of life of caregivers of people living with dementia.

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study Start: 2024-01-10
• Study First Posted: 2024-01-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-08-08
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia
2. 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
3. own a smartphone/tablet (i.e., can access either IOS or Android platforms).

Exclusion Criteria

1. Currently using an app for caregiver stress/burden

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-weeks	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)	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
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up	The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period	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
Change from after the 8-week period in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up	The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period	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
Change from baseline in the BSFC-S total scores at a 4-week follow-up	The BSFC-S will be administered at baseline (i.e., prior to starting the study) and 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
Change from after the 8-week period in the BSFC-S total scores at a 4-week follow-up	The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period	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
Change from after the 8-week period in the PHQ-9 total scores at a 4-week follow-up	The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period	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.
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total scores at 8-weeks	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)	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.
Change from baseline in the GAD-7 total scores at a 4-week follow-up	The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period	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.
Change from baseline in the Burden Scale for Family Caregivers-Short Version (BSFC-S) total scores at 8-weeks	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)	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
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total scores at 8-weeks	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)	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.
Change from baseline in the PHQ-9 total scores at a 4-week follow-up	The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period	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.
Change from after the 8-week period in the GAD-7 total scores at a 4-week follow-up	The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period	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.

Secondary Outcome Measures

Name	Time	Method
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)	The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up	The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period	Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.
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	The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
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	The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
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)	The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
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	The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
Change from after the 8-week period in the CSES-8 total scores at a 4-week follow-up	The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period	The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks	The Brief-COPE 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)	Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.
Change from after the 8-week period in the Brief-COPE subscale scores at a 4-week follow-up	The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period	Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.

Trial Locations

Locations (1)

University of Regina; 🇨🇦 Regina, Saskatchewan, Canada