Carer Stress SyndromeNCT04490135
Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia
A study testing Group psychotherapy in people with Carer Stress Syndrome, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Family caregivers (CG) of persons with dementia are vulnerable to disproportionate physical, mental and social adverse health consequences . The Reitman Centre CARERS program is an innovative, group psychotherapeutic skills-training intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carer Stress Syndrome
- What is being tested?
- Group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2013to 31 Dec 2017
- 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
- adult, informal caregiver (CG) of a person with diagnosis of dementia who resided in the community; sufficient emotional and physical capacity to participate in the assessment and training sessions; no active suicidality or psychotic illness; willing to discontinue other CG intervention programs while in the study; and provided signed consent for the study.
Who cannot join
- insufficient emotional and physical capacity to participate in the assessment and training sessions; active suicidality or psychotic illness; unwilling to discontinue other CG intervention programs while in the study
Trial locations and contacts
1 site in 1 country.
About this study
Family caregivers (CG) of persons with dementia are vulnerable to disproportionate physical, mental and social adverse health consequences . The Reitman Centre CARERS program is an innovative, group psychotherapeutic skills-training intervention.
Study objective: to determine the effectiveness of the Reitman Centre CARERS program on key outcomes in family CGs of people with dementia. Study sample: Family CGs of people with dementia (n=264) referred to Reitman Center and the partner sites and wait-list control group (n=83) who received regular care. Method: quasi-experimental, non-randomized, multiple group trial; participants were evaluated before and after completion of the 8-week CARERS program in comparison.
Read the detailed description
Addressing the adverse effects of caregiving on dementia CGs has been an increasing concern of mental and social health scholars in recent decades. Many single and multi-component programs have been developed but evidence for the effectiveness of interventions varies. Single component interventions for CGs like education, psychotherapy, or skills training are effective on various outcome measures but multicomponent programs appear to be preferred for overall reduction of caregiver burden. Broad development and system-wide adoption of interventions lags behind and there remains a need for evidence-based interventions that can be scaled widely in systems of dementia care.
This study aimed to compare the effectiveness of the Reitman Centre CARERS group intervention on measures of CG's health and well-being with a usual-care intervention control group. We hypothesized that the integrated, multicomponent CARERS program would produce robust positive effects on key outcome measures compared to waiting list controls. This was a quasi-experimental design with a convenience sample and a non-randomized wait-list control group implemented between 2013 and 2017. The control group received usual care before starting the CARERS intervention.The waiting list control group was derived from all CGs who were clinically assessed for the CARERS program, consented to enter the study and completed initial study assessments before being put on the waiting list for a CARERS group. A waiting list control was employed for practical recruitment purposes. This study was approved by the Sinai Health System (SHS) Research Ethics Board. Every participant provided informed signed written consent for all study components.Referrals to the study came from community agencies serving older adults, self-referrals, and primary care, memory, general psychiatry and geriatric medicine clinics. The intervention sites were located at Reitman Centre (CR) and Wellness Centre at Mount Sinai Hospital, Bridgepoint Active Health, Ceridian LifeWorks® EAP, Canadian Alzheimer Society chapters and community agencies serving older adults.
The intervention, called Carers, is a multicomponent, group psychotherapeutic, skills-training intervention for family CGs comprised of 8 weekly 2 hour closed groups sessions. of 4-6 CGs co-led by 2 mental health clinicians who follow a protocol that includes predetermined agendas that structure the outline of each group. The group leaders are trained to elicit and address the specific concerns of each CG during each session. The content of each group is determined by the CGs based on an initial go-round check-in to elicit current caregiving problems and challenges, emotional reactions and foster group cohesion. In sessions 1-4, CGs are formally taught a form of problem-solving therapy (PST) adapted for dementia CGs. Sessions 5-8 utilize simulation to train CGs to effectively communicate with the person they are caring for and learn how to engage with them to manage dementia induced behaviours such as resistance or demandingness. Communication training is done with live therapeutic simulation a hands-on training method that employs specially trained standardized patients (SP) in a tightly controlled intervention developed for the CARERS program. All group leaders were trained in a standardized training protocol at the Reitman Centre. CGs completed self-administered questionnaires at entry to the study, just prior to starting the first group and, immediately after session 8 of the group therapy. Care recipient (CR)function and demographic and socioeconomic information was gathered for each CG/CR at entry into the study. Statistical analysis employed IBM SPSS 26 and univariate general linear model (UNIANOVA) analysis and parametric tests.
- Conditions
- Carer Stress Syndrome
- Being tested
- Group psychotherapy
- Keywords
- Carer, Psychotherapy, Problem solving, Simulation, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group psychotherapyBehavioural
As described above
| Study group | Role | What they receive |
|---|---|---|
| Carers group intervention | Experimental | caregivers entered into the 8 week CARERS intervention (N=264) Group intervention, 8 x 2 hour sessions. Session 1-4 PST training, session 5-8 Simulation with standardized patients training Pre- post evaluations completed Receives: Behavioral: Group psychotherapy |
| Wating list control | No intervention | Caregivers waiting for entry into active arm of CARERS intervention.During this time usual care allowed with no other intervention. Study measures administered at intake and immediately prior to starting the CARERS group. (N=83) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977
standardized diagnostic measure of depression
Measured: Change in depression score from baseline at 8 weeks
perceived stress scale - PSS Cohen, S et al., 1983
self assessment standardized measure of self perceived stress
Measured: Change in stress score from baseline at 8 weeks
Mastery (Pearlin et al., 1990)
self assessment standardized measure of perceived sense of mastery in caregiving
Measured: Change in mastery score from baseline 8 weeks
caregiving competence(Pearlin et al., 1990)
Self assessment standardized measure of key areas of perceived competence in caregiving
Measured: Change in caregiving competence score from baseline at 8 weeks
role captivity (Pearlin et al., 1990)
Self administered standardized measure of degree of perceived entrapment in the caregiving role
Measured: Change in role captivity score from baseline at 8 weeks
role overload(Pearlin et al., 1990)
self administered standardized measure of degree of experienced caregiving overload
Measured: Change in role overload score from baseline at 8 weeks
Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)
Self administered Standardized measure of burden of caregiving
Measured: Change in burden score from baseline at 8 weeks
coping (Endler and Parker 1990)
Self administered scale of caregiver's perception of coping
Measured: Change from Baseline at 8 weeks
coping (Endler & Parker, 1990)
Self administered scale of caregivers perception of coping
Measured: Change in coping from baseline at 8 weeks
Secondary outcomes (4)
Caregiver demographics
general demographic profile
Measured: through study completion on average about 4 months
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)
Measure of care recipient daily function as observed by caregiver
Measured: change from Baseline at 8 weeks
Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)
measure of care recipients daily instrumental activities of daily living as observed by the caregiver
Measured: Change from Baseline at 8 weeks
Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)
Caregiver's reaction to CR's memory and behavioural symptoms (completed by caregiver)
Measured: Baseline and after completion of the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jan 2013
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carer Stress SyndromeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- a quasi-experimental design with a convenience sample and a non-randomized wait-list control group
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Sadavoy, Mount Sinai Hospital, Canada
- Investigators
- Joel Sadavoy, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490135
- Sponsor's protocol ID
- CARERSMountSinaiH
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons With Dementia
- ClinicalTrials.gov ID
- NCT04490135
- Acronym / sponsor ID
- CARERSMountSinaiH
- Conditions
- Carer Stress Syndrome
- Keywords
- Carer, Psychotherapy, Problem solving, Simulation, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Jul 2020 (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.
Family caregivers (CG) of persons with dementia are vulnerable to disproportionate physical, mental and social adverse health consequences . The Reitman Centre CARERS program is an innovative, group psychotherapeutic skills-training intervention.
Study objective: to determine the effectiveness of the Reitman Centre CARERS program on key outcomes in family CGs of people with dementia. Study sample: Family CGs of people with dementia (n=264) referred to Reitman Center and the partner sites and wait-list control group (n=83) who received regular care. Method: quasi-experimental, non-randomized, multiple group trial; participants were evaluated before and after completion of the 8-week CARERS program in comparison.
Detailed description
Addressing the adverse effects of caregiving on dementia CGs has been an increasing concern of mental and social health scholars in recent decades. Many single and multi-component programs have been developed but evidence for the effectiveness of interventions varies. Single component interventions for CGs like education, psychotherapy, or skills training are effective on various outcome measures but multicomponent programs appear to be preferred for overall reduction of caregiver burden. Broad development and system-wide adoption of interventions lags behind and there remains a need for evidence-based interventions that can be scaled widely in systems of dementia care.
This study aimed to compare the effectiveness of the Reitman Centre CARERS group intervention on measures of CG's health and well-being with a usual-care intervention control group. We hypothesized that the integrated, multicomponent CARERS program would produce robust positive effects on key outcome measures compared to waiting list controls. This was a quasi-experimental design with a convenience sample and a non-randomized wait-list control group implemented between 2013 and 2017. The control group received usual care before starting the CARERS intervention.The waiting list control group was derived from all CGs who were clinically assessed for the CARERS program, consented to enter the study and completed initial study assessments before being put on the waiting list for a CARERS group. A waiting list control was employed for practical recruitment purposes. This study was approved by the Sinai Health System (SHS) Research Ethics Board. Every participant provided informed signed written consent for all study components.Referrals to the study came from community agencies serving older adults, self-referrals, and primary care, memory, general psychiatry and geriatric medicine clinics. The intervention sites were located at Reitman Centre (CR) and Wellness Centre at Mount Sinai Hospital, Bridgepoint Active Health, Ceridian LifeWorks® EAP, Canadian Alzheimer Society chapters and community agencies serving older adults.
The intervention, called Carers, is a multicomponent, group psychotherapeutic, skills-training intervention for family CGs comprised of 8 weekly 2 hour closed groups sessions. of 4-6 CGs co-led by 2 mental health clinicians who follow a protocol that includes predetermined agendas that structure the outline of each group. The group leaders are trained to elicit and address the specific concerns of each CG during each session. The content of each group is determined by the CGs based on an initial go-round check-in to elicit current caregiving problems and challenges, emotional reactions and foster group cohesion. In sessions 1-4, CGs are formally taught a form of problem-solving therapy (PST) adapted for dementia CGs. Sessions 5-8 utilize simulation to train CGs to effectively communicate with the person they are caring for and learn how to engage with them to manage dementia induced behaviours such as resistance or demandingness. Communication training is done with live therapeutic simulation a hands-on training method that employs specially trained standardized patients (SP) in a tightly controlled intervention developed for the CARERS program. All group leaders were trained in a standardized training protocol at the Reitman Centre. CGs completed self-administered questionnaires at entry to the study, just prior to starting the first group and, immediately after session 8 of the group therapy. Care recipient (CR)function and demographic and socioeconomic information was gathered for each CG/CR at entry into the study. Statistical analysis employed IBM SPSS 26 and univariate general linear model (UNIANOVA) analysis and parametric tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a quasi-experimental design with a convenience sample and a non-randomized wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Carers group intervention | Experimental | Behavioral: Group psychotherapycaregivers entered into the 8 week CARERS intervention (N=264) Group intervention, 8 x 2 hour sessions. Session 1-4 PST training, session 5-8 Simulation with standardized patients training Pre- post evaluations completed |
| Wating list control | No intervention | –Caregivers waiting for entry into active arm of CARERS intervention.During this time usual care allowed with no other intervention. Study measures administered at intake and immediately prior to starting the CARERS group. (N=83) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult, informal caregiver (CG) of a person with diagnosis of dementia who resided in the community; sufficient emotional and physical capacity to participate in the assessment and training sessions; no active suicidality or psychotic illness; willing to discontinue other CG intervention programs while in the study; and provided signed consent for the study.
Key exclusion criteria (1 listed)
- insufficient emotional and physical capacity to participate in the assessment and training sessions; active suicidality or psychotic illness; unwilling to discontinue other CG intervention programs while in the study
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 |
|---|---|---|
| Group psychotherapyAs described above | Behavioural | Carers group intervention |
Primary outcome
Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977
Time frame: Change in depression score from baseline at 8 weeks
standardized diagnostic measure of depression
perceived stress scale - PSS Cohen, S et al., 1983
Time frame: Change in stress score from baseline at 8 weeks
self assessment standardized measure of self perceived stress
Mastery (Pearlin et al., 1990)
Time frame: Change in mastery score from baseline 8 weeks
self assessment standardized measure of perceived sense of mastery in caregiving
caregiving competence(Pearlin et al., 1990)
Time frame: Change in caregiving competence score from baseline at 8 weeks
Self assessment standardized measure of key areas of perceived competence in caregiving
role captivity (Pearlin et al., 1990)
Time frame: Change in role captivity score from baseline at 8 weeks
Self administered standardized measure of degree of perceived entrapment in the caregiving role
role overload(Pearlin et al., 1990)
Time frame: Change in role overload score from baseline at 8 weeks
self administered standardized measure of degree of experienced caregiving overload
Short Zarit Burden Inventory- SZBI), (Bedard et al., 2001)
Time frame: Change in burden score from baseline at 8 weeks
Self administered Standardized measure of burden of caregiving
coping (Endler and Parker 1990)
Time frame: Change from Baseline at 8 weeks
Self administered scale of caregiver's perception of coping
coping (Endler & Parker, 1990)
Time frame: Change in coping from baseline at 8 weeks
Self administered scale of caregivers perception of coping
4 secondary outcomes
Caregiver demographics
Time frame: through study completion on average about 4 months
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Katz, Downs, Cash, & Grotz, 1970)
Time frame: change from Baseline at 8 weeks
Lawton Instrumental Activities of Daily Living Scale (Lawton ADL) (Lawton & Brody, 1969)
Time frame: Change from Baseline at 8 weeks
Revised Memory and Behaviour Checklist- RMBPC) (Teri et al., 1992)
Time frame: Baseline and after completion of the 8 week intervention
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 29 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Joel Sadavoy principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group psychotherapy in people with Carer Stress Syndrome, run by Mount Sinai Hospital, Canada 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 1 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 29 Jul 2020. 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?
Center for Epidemiologic Studies Depression Scale- CESD) Eaton et al., 1977 (time frame: Change in depression score from baseline at 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2020.