Caregiver BurdenNCT06203639

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

A study testing UR Caregiver and CLEAR Dementia Care in people with Caregiver Burden, run by University of Regina at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caregiver Burden
What is being tested?: UR Caregiver and CLEAR Dementia Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteCanada
Study dates: 10 Jan 2024to 30 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

1) Currently using an app for caregiver stress/burden

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Regina
Regina, Saskatchewan, S4S 0A2

Other trials in Canada

About this study

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

Read the 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.

Conditions: Caregiver Burden
Being tested: UR Caregiver, CLEAR Dementia Care
Keywords: Dementia, mobile app
Medical subject headings: Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UR CaregiverOther
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 CareOther
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.

Study groups in NCT06203639
Study group	Role	What they receive
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. Receives: 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. Receives: Other: CLEAR Dementia Care
Non-app using control	No intervention	Participants in this group will not be using any apps in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: The CSES-8 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 CSES-8 total scores at a 4-week follow-up
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.
Measured: The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks
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.
Measured: 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)
Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up
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.
Measured: The Brief-COPE 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 Brief-COPE subscale scores at a 4-week follow-up
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.
Measured: The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202430 Jan 2025

First posted12 Jan 2024
Study start10 Jan 2024
Primary completion30 Jan 2025
Study completion30 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Caregiver BurdenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to one of the three group conditions: 1) UR Caregiver; 2) active control group; and 2) control group.
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06203639
Sponsor's protocol ID: 2022-069
Status last verified: Apr 2026
First submitted: 2 Jan 2024
Last updated: 14 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Non-identified numeric 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. Textual data from the interviews will not be shared to protect participant anonymity.

Publications

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.
PubMed 6668417
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.
PubMed 24555474
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.
PubMed 11556941
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.
PubMed 16717171
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.
PubMed 16250744
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.
PubMed 33146727

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Preliminary Evaluation of an App to Reduce Caregiver Stress and Burden Among Informal Caregivers of People Living With Dementia
ClinicalTrials.gov ID: NCT06203639
Acronym / sponsor ID: 2022-069
Conditions: Caregiver Burden
Keywords: Dementia, mobile app
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: University of ReginaUniversity, hospital or other
Study start: 10 Jan 2024 (actual)
Primary completion: 30 Jan 2025 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 12 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants will be randomly assigned to one of the three group conditions: 1) UR Caregiver; 2) active control group; and 2) control group.

Arm	Type	Receives
UR Caregiver group	Experimental	Other: UR CaregiverParticipants 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.
Active control	Active comparator	Other: CLEAR Dementia CareParticipants will be asked to use the app daily (e.g., at least 15 minutes/day) for an 8-week period.
Non-app using control	No intervention	–Participants in this group will not be using any apps in the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (1 listed)

1) Currently using an app for caregiver stress/burden

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UR CaregiverThe 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.	Other	UR Caregiver group
CLEAR Dementia CareA 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.	Other	Active control

Primary outcome

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
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
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
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
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
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
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.
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.
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.
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.
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.
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.

9 secondary outcomes

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)
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
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
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)
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
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
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)
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Background: PubMed 24555474Graessel 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.
Background: PubMed 11556941Kroenke 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.
Background: PubMed 16717171Spitzer 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.
Background: PubMed 16250744Carver 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.
Background: PubMed 33146727Ritter 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.
Individual participant dataSharing planned: Yes. Non-identified numeric 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. Textual data from the interviews will not be shared to protect participant anonymity.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Hadjistavropoulos, PhD principal investigator

University of Regina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing UR Caregiver and CLEAR Dementia Care in people with Caregiver Burden, run by University of Regina at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06203639, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.