Study Summary
This trial will explore whether a new counseling program can improve mental health for people who care for loved ones with dementia, in Canada. 80 people will be recruited and randomly assigned to either the counseling program or to usual care services, and mixed methods will be used to evaluate the potential impact of the counseling program.
Eligible Conditions
- Dementia
- Digital Health
- Acceptance and Commitment Therapy
- Mental Health
- Counseling
- Technology
- Caregiver Burden
- Psychotherapy
Treatment Effectiveness
Study Objectives
8 Primary · 6 Secondary · Reporting Duration: Through study completion up to 1 year
Week 36
Anxiety
Change in Acceptance and Action
Change in Baseline Caregiver Burden up to 36 weeks as assessed by the Zarit Burden Index
Change in Baseline Caregiver Participation in Meaningful and Fulfilling Activities up to 36 weeks as assessed by the Engagement in Meaningful Activities Scale
Change in Baseline Depression, Anxiety and Stress up to 36 weeks as assessed by the Depression, Anxiety and Stress Scale
Change in Caregiver Burden up to 36 weeks
Change in Engagement in Meaningful Activities up to 36 weeks
Change in Psychological Flexibility and Experiential Avoidance up to 36 weeks as assessed by the Acceptance and Action Questionnaire
Year 1
Feasibility and Acceptability of ACT Intervention
Feasibility and Acceptability of Implementing the ACT Intervention as planned through study completion up to 1 year as assessed by recruitment, retention and attrition rates, and participant demographics
Week 36
Acceptability of ACT Intervention Technology Used for Remote Delivery up to 36 weeks as assessed by the System Usability Scale
Acceptability of ACT Intervention Technology for Remote Delivery
Satisfaction with ACT Intervention
Satisfaction with ACT Intervention Delivery, Content and Processes up to 36 weeks as assessed by the Client Satisfaction Questionnaire
Trial Safety
Trial Design
2 Treatment Groups
Usual Care
1 of 2
ACT Intervention
1 of 2
Active Control
Experimental Treatment
80 Total Participants · 2 Treatment Groups
Primary Treatment: ACT Intervention · No Placebo Group · N/A
ACT Intervention
Behavioral
Experimental Group · 1 Intervention: ACT Intervention · Intervention Types: BehavioralUsual Care
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion up to 1 year
Who is running the clinical trial?
University of New BrunswickLead Sponsor
19 Previous Clinical Trials
2,354 Total Patients Enrolled
1 Trials studying Dementia
41 Patients Enrolled for Dementia
Mount Allison UniversityUNKNOWN
McMaster UniversityOTHER
801 Previous Clinical Trials
1,727,797 Total Patients Enrolled
6 Trials studying Dementia
825 Patients Enrolled for Dementia
University of OttawaOTHER
177 Previous Clinical Trials
246,836 Total Patients Enrolled
McGill UniversityOTHER
359 Previous Clinical Trials
976,737 Total Patients Enrolled
5 Trials studying Dementia
3,659 Patients Enrolled for Dementia
Alzheimer Society of New BrunswickUNKNOWN
Pamela Durepos, PhDPrincipal InvestigatorUniversity of New Brunswick
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are an adult over 19 years old residing in New Brunswick, Canada.
You have a high level of depression, anxiety or stress.
Who else is applying?
What state do they live in?
| New Brunswick | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Alzheimer Society of New Brunswick | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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