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Completed

NCT Number: NCT06203639

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

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Currently using an app for caregiver stress/burden

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Change from after the 8-week period in the CSES-8 total scores at a 4-week follow-up

    Time frame: 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.

  7. Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks

    Time frame: 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.

  8. Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up

    Time frame: 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.

  9. Change from after the 8-week period in the Brief-COPE subscale scores at a 4-week follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Registry information

Official study title

Development and Preliminary Evaluation of an App to Reduce Caregiver Stress and Burden Among Informal Caregivers of People Living With Dementia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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