Acceptance and Commitment TherapyNCT05385458
Acceptance and Commitment Therapy (ACT) Tele-Counselling
A study testing ACT Intervention in people with Acceptance and Commitment Therapy and Caregiver Burden, run by University of New Brunswick at 1 site in Canada.
Trial summary
A randomized 2-group controlled trial will be conducted to explore the potential effect and potential feasibility of a new Acceptance and Commitment Therapy (ACT) tele-counselling program to improve mental health services for family caregivers of persons with dementia in the province of New Brunswick in Canada. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acceptance and Commitment Therapy, Caregiver Burden, Digital Health
- What is being tested?
- ACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2022to 25 Mar 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult over 19 years old residing in New Brunswick, Canada
- Able to speak and read English or French
- Unpaid, informal caregiver to a person living with dementia (no diagnosis required)
- High level on 2 subscales or less on the Depression, Anxiety and Stress Scale
- Current or previous use of any mental health services
Who cannot join
- Less than 19 years old or not residing in New Brunswick, Canada
- Unable to speak and read English or French
- Not an unpaid informal caregiver to a person living with dementia
- High level on more than 2 subscales on the Depression, Anxiety and Stress Scale
- Acute mental health disorder such as: schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alzheimer Society of New Brunswick
Fredericton, New Brunswick, E3A 3R4
About this study
Official title: Acceptance and Commitment Therapy (ACT) Through Tele-Counselling for Family Caregivers in New Brunswick
A randomized 2-group controlled trial will be conducted to explore the potential effect and potential feasibility of a new Acceptance and Commitment Therapy (ACT) tele-counselling program to improve mental health services for family caregivers of persons with dementia in the province of New Brunswick in Canada. The ACT tele-counselling program was launched in January 2021 with the aim of improving access to high quality psychotherapy for family caregivers, particularly in rural areas. A target sample size of 80 participants will be recruited and randomly allocated to either the ACT program or to usual care services. Mixed methods (QUANTITATIVE + qualitative) will be used to evaluate the potential impact of the ACT program compared to usual care on participant's mental health, and to generate recommendations for the expansion and continuation of the program outside of the province.
Read the detailed description
Family caregivers of persons with dementia have limited access to high quality psychotherapy in NB and across Canada, despite experiencing high levels of burden, depression, anxiety and social isolation. This feasibility pilot study will use a randomized two-group controlled trial design to evaluate the feasibility, acceptability and potential effect of a new Acceptance and Commitment Therapy (ACT) tele-counselling program offered by the Alzheimer Society of NB to family/friend caregivers. The program was launched in February 2021 and requires evaluation to maintain funding and inform implementation practices (i.e., scale-up) into other provinces.
Approximately 80 French/English-speaking adult caregivers of persons living with dementia will be recruited to participate in the study. We anticipate an attrition rate of approximately 25% and aim to retain a sample of 60 (30 participants per group). Participants will be screened for eligibility and those who demonstrate severe anxiety, depression or stress in 2 or more subscales according to the DASS-21 questionnaire will not be eligible to participate in the study and will be enrolled directly to the ACT program at the Alzheimer Society of NB. Eligible participants will be randomly assigned to either a usual care or intervention group.
Usual Care Group: Participants will receive usual care services at the Alzheimer Society including: First Link check-in telephone call once at the beginning of the study and a 2nd phone call 3 months later from an Alzheimer Society staff member. They would also have access to monthly support groups and education classes as they wish. Use of services will be tracked as per usual by the Alzheimer Society over 12 weeks.
Intervention Group: Participants will attend 6-8 individual tele-counselling sessions over 12-24 weeks with the psychotherapist who developed the ACT program at the Alzheimer Society. Sessions will last 45-60 minutes and be delivered in French or English via text, Zoom or telephone using Health Insurance Portability and Accountability Act (HIPAA) compliant technology. Participants will select their preferred mode of delivery for the program. Sessions will include ACT methods such as: identifying presenting concerns, making contact with the present moment, identifying values, accepting the situation and setting boundaries/expectations, and examining thoughts. All sessions will be recorded and 20% randomly selected to be reviewed by a research team member to evaluate intervention fidelity. Participants can refuse to have their session recorded and remain in the study. Participants in the Intervention Group will also have access to Usual Care services.
Participants will complete a pre-post test with outcome measures completed at baseline (T1) and after attending either Usual Care or the ACT program (T2) to assess potential effect. Participants will complete electronic or paper questionnaires (administered and returned via postal mail). Questionnaires have evidence for reliability and validity in French and English and have been used to evaluate ACT effectiveness in family caregivers. Outcome measures will include: Depression, Anxiety and Stress Scale (DASS-21), Acceptance and Action Questionnaire II (AAQ-11), Zarit Caregiver Burden-6 (ZBI-6), and the Engagement in Meaningful Activities Survey (EMAS).
Feasibility and acceptability of the intervention will be evaluated by tracking participant movement (i.e., recruitment, retention, sessions completed). Participants in the Intervention Group will also complete the System Usability Scale (SUS) and the Client Satisfaction Questionnaire (CSQ-8) after completing the Intervention. Telephone or computer interviews lasting 1 hour will be conducted with 10 participants in the Intervention Group to explore perceptions of the intervention, facilitators and barriers. 1 computer or telephone focus group will be conducted with 5-6 staff members of the Alzheimer Society involved in delivery of the program to explore perceptions and recommendations for program implementation and scale-up. Interviews and the focus group will be audio recorded and transcribed.
- Conditions
- Acceptance and Commitment Therapy, Caregiver Burden, Digital Health, Technology, Mental Health, Psychotherapy
- Being tested
- ACT Intervention, Usual Care
- Medical subject headings
- Caregiver Burden, Psychological Well-Being, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT InterventionBehavioural
Acceptance and Commitment Therapy
Usual CareOther
Usual Care Services
| Study group | Role | What they receive |
|---|---|---|
| ACT Intervention | Experimental | Participants will attend 6-8 individual psychotherapy sessions via telephone, text or videoconference. Sessions will last approximately 1 hour and occur every 3-4 weeks. Participants will be enrolled in the Intervention Group for 18-36 weeks. All sessions will be audio recorded. Participants will also be able to attend all available usual care services such as: support groups, First Link, education classes at the Alzheimer Society. Any services utilized will be documented by Alzheimer Society staff. Receives: Behavioral: ACT Intervention |
| Usual Care | Active comparator | Participants will be enrolled as an Alzheimer Society client. Participants will receive 1 First Link 'check-in' telephone call from a staff member at the time of enrolment. Participants will receive a 2nd 'check-in' First Link telephone call from a staff member 3-4 months following enrolment. Participants will be enrolled in the Usual Care Group 12-16 weeks. Participants will also be able to attend all available usual care services such as: support groups, etc. Any services utilized will be documented by Alzheimer Society staff. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Depression, Anxiety and Stress up to 36 weeks as assessed by the Depression, Anxiety and Stress Scale
The Depression, Anxiety and Stress Scale (DASS-21) scale has 21 items with a 3 point likert scale. Range is 0-189 with higher scores indicating greater symptoms of depression, anxiety and stress.
Measured: Baseline through study completion up to 36 weeks
Change in Baseline Caregiver Burden up to 36 weeks as assessed by the Zarit Burden Index
The Zarit Burden Index (ZBI-12) is a 12 Item questionnaire with 5 point likert scale. Range is 0-48 with higher scores indicating higher symptoms of caregiver burden.
Measured: Baseline through study completion up to 36 weeks
Change in Baseline Caregiver Participation in Meaningful and Fulfilling Activities up to 36 weeks as assessed by the Engagement in Meaningful Activities Scale
The Engagement in Meaningful Activities Scale (EMAS) assesses the alignment between a person's actions/activities in daily life and their personal values. Increasing engagement in meaningful activities is a goal of ACT. This scale has 12 items with 5 point likert scale. Range is 12-72 with higher scores indicating higher (better) engagement in meaningful activities.
Measured: Baseline through study completion up to 36 weeks
Change in Psychological Flexibility and Experiential Avoidance up to 36 weeks as assessed by the Acceptance and Action Questionnaire
The Acceptance and Action Questionnaire (AAQ-II) was developed to evaluate the effectiveness of ACT behavioural therapy, which aims to increase psychological flexibility and decrease experiential avoidance. Psychological flexibility refers to a person's ability to recognize and adapt to situational demands; shift perspectives, thinking or behaviours that reduce personal or social functioning; maintain balance among important life domains; and be aware, open, and committed to behaviors that align with personal values (Kashdan, 2010). The questionnaire includes 7 Items with a 7 point likert scale. Range is 7-49 with lower scores indicating higher (better) psychological flexibility and lower (better) experiential avoidance.
Measured: Baseline through study completion up to 36 weeks
Secondary outcomes (3)
Acceptability of ACT Intervention Technology Used for Remote Delivery up to 36 weeks as assessed by the System Usability Scale
An adapted version of the System Usability Scale (SUS) will be used to asses how acceptable and easy it is for caregivers to use technology (telephone, text, videoconference) to attend the ACT intervention tele-counselling sessions remotely. The scale includes a 10 item scale with 5 point likert scale. Range is 10-50 with higher scores indicating higher acceptability.
Measured: Through study completion up to 36 weeks
Satisfaction with ACT Intervention Delivery, Content and Processes up to 36 weeks as assessed by the Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ-8) scale assesses perceptions of the quality of a service or program, whether the service has met expectations and needs, likelihood of recommending the service to others, and perceived effectiveness/helpfulness of the service. The scale includes 8 items with a 4 point likert scale. Range is 8-32 with higher scores indicating higher satisfaction.
Measured: Through study completion up to 36 weeks
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
Feasibility and acceptability of the ACT intervention will be assessed through participant tracking and statistical analysis of frequencies and descriptive statistics to understand recruitment, retention and attrition rates, number of tele-counselling sessions completed, and diversity of participant demographics (i.e., gender, geographical area, language spoken, age) recruited and who complete the study.
Measured: Through study completion up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start30 May 2022
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acceptance and Commitment TherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of New Brunswick, Mount Allison University, University of Ottawa, McMaster University, McGill University
- Responsible party
- Principal investigator, Pamela Durepos, University of New Brunswick
- Investigators
- Pamela Durepos, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385458
- Sponsor's protocol ID
- MHRC-NBHRF Mental Health
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with researchers outside of the study.
Publications
Durepos P, Ricketts N, Olthuis JV, Gould ON, Boamah SA, McCloskey R, Lanteigne M, Giberson ER, Caverhill K, Pickford K, MacBean C, Kaasalainen S. Acceptance and Commitment Therapy Tele-Counselling Program With Care Partners of Persons Living With Dementia: A Pilot Feasibility RCT. J Appl Gerontol. 2026 Feb;45(2):225-236. doi: 10.1177/07334648251338303. Epub 2025 May 12.
PubMed 40353485
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy (ACT) Through Tele-Counselling for Family Caregivers in New Brunswick
- ClinicalTrials.gov ID
- NCT05385458
- Acronym / sponsor ID
- MHRC-NBHRF Mental Health
- Conditions
- Acceptance and Commitment Therapy, Caregiver Burden, Digital Health, Technology, Mental Health, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Alzheimer Society of New Brunswick, Mount Allison University, University of Ottawa, McMaster University, McGill University
- Study start
- 30 May 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 23 May 2022 (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.
A randomized 2-group controlled trial will be conducted to explore the potential effect and potential feasibility of a new Acceptance and Commitment Therapy (ACT) tele-counselling program to improve mental health services for family caregivers of persons with dementia in the province of New Brunswick in Canada. The ACT tele-counselling program was launched in January 2021 with the aim of improving access to high quality psychotherapy for family caregivers, particularly in rural areas. A target sample size of 80 participants will be recruited and randomly allocated to either the ACT program or to usual care services. Mixed methods (QUANTITATIVE + qualitative) will be used to evaluate the potential impact of the ACT program compared to usual care on participant's mental health, and to generate recommendations for the expansion and continuation of the program outside of the province.
Detailed description
Family caregivers of persons with dementia have limited access to high quality psychotherapy in NB and across Canada, despite experiencing high levels of burden, depression, anxiety and social isolation. This feasibility pilot study will use a randomized two-group controlled trial design to evaluate the feasibility, acceptability and potential effect of a new Acceptance and Commitment Therapy (ACT) tele-counselling program offered by the Alzheimer Society of NB to family/friend caregivers. The program was launched in February 2021 and requires evaluation to maintain funding and inform implementation practices (i.e., scale-up) into other provinces.
Approximately 80 French/English-speaking adult caregivers of persons living with dementia will be recruited to participate in the study. We anticipate an attrition rate of approximately 25% and aim to retain a sample of 60 (30 participants per group). Participants will be screened for eligibility and those who demonstrate severe anxiety, depression or stress in 2 or more subscales according to the DASS-21 questionnaire will not be eligible to participate in the study and will be enrolled directly to the ACT program at the Alzheimer Society of NB. Eligible participants will be randomly assigned to either a usual care or intervention group.
Usual Care Group: Participants will receive usual care services at the Alzheimer Society including: First Link check-in telephone call once at the beginning of the study and a 2nd phone call 3 months later from an Alzheimer Society staff member. They would also have access to monthly support groups and education classes as they wish. Use of services will be tracked as per usual by the Alzheimer Society over 12 weeks.
Intervention Group: Participants will attend 6-8 individual tele-counselling sessions over 12-24 weeks with the psychotherapist who developed the ACT program at the Alzheimer Society. Sessions will last 45-60 minutes and be delivered in French or English via text, Zoom or telephone using Health Insurance Portability and Accountability Act (HIPAA) compliant technology. Participants will select their preferred mode of delivery for the program. Sessions will include ACT methods such as: identifying presenting concerns, making contact with the present moment, identifying values, accepting the situation and setting boundaries/expectations, and examining thoughts. All sessions will be recorded and 20% randomly selected to be reviewed by a research team member to evaluate intervention fidelity. Participants can refuse to have their session recorded and remain in the study. Participants in the Intervention Group will also have access to Usual Care services.
Participants will complete a pre-post test with outcome measures completed at baseline (T1) and after attending either Usual Care or the ACT program (T2) to assess potential effect. Participants will complete electronic or paper questionnaires (administered and returned via postal mail). Questionnaires have evidence for reliability and validity in French and English and have been used to evaluate ACT effectiveness in family caregivers. Outcome measures will include: Depression, Anxiety and Stress Scale (DASS-21), Acceptance and Action Questionnaire II (AAQ-11), Zarit Caregiver Burden-6 (ZBI-6), and the Engagement in Meaningful Activities Survey (EMAS).
Feasibility and acceptability of the intervention will be evaluated by tracking participant movement (i.e., recruitment, retention, sessions completed). Participants in the Intervention Group will also complete the System Usability Scale (SUS) and the Client Satisfaction Questionnaire (CSQ-8) after completing the Intervention. Telephone or computer interviews lasting 1 hour will be conducted with 10 participants in the Intervention Group to explore perceptions of the intervention, facilitators and barriers. 1 computer or telephone focus group will be conducted with 5-6 staff members of the Alzheimer Society involved in delivery of the program to explore perceptions and recommendations for program implementation and scale-up. Interviews and the focus group will be audio recorded and transcribed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ACT Intervention | Experimental | Behavioral: ACT InterventionParticipants will attend 6-8 individual psychotherapy sessions via telephone, text or videoconference. Sessions will last approximately 1 hour and occur every 3-4 weeks. Participants will be enrolled in the Intervention Group for 18-36 weeks. All sessions will be audio recorded. Participants will also be able to attend all available usual care services such as: support groups, First Link, education classes at the Alzheimer Society. Any services utilized will be documented by Alzheimer Society staff. |
| Usual Care | Active comparator | Other: Usual CareParticipants will be enrolled as an Alzheimer Society client. Participants will receive 1 First Link 'check-in' telephone call from a staff member at the time of enrolment. Participants will receive a 2nd 'check-in' First Link telephone call from a staff member 3-4 months following enrolment. Participants will be enrolled in the Usual Care Group 12-16 weeks. Participants will also be able to attend all available usual care services such as: support groups, etc. Any services utilized will be documented by Alzheimer Society staff. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult over 19 years old residing in New Brunswick, Canada
- Able to speak and read English or French
- Unpaid, informal caregiver to a person living with dementia (no diagnosis required)
- High level on 2 subscales or less on the Depression, Anxiety and Stress Scale
- Current or previous use of any mental health services
Key exclusion criteria (5 listed)
- Less than 19 years old or not residing in New Brunswick, Canada
- Unable to speak and read English or French
- Not an unpaid informal caregiver to a person living with dementia
- High level on more than 2 subscales on the Depression, Anxiety and Stress Scale
- Acute mental health disorder such as: schizophrenia or bipolar disorder
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 |
|---|---|---|
| ACT InterventionAcceptance and Commitment Therapy | Behavioural | ACT Intervention |
| Usual CareUsual Care Services | Other | Usual Care |
Primary outcome
Change in Baseline Depression, Anxiety and Stress up to 36 weeks as assessed by the Depression, Anxiety and Stress Scale
Time frame: Baseline through study completion up to 36 weeks
The Depression, Anxiety and Stress Scale (DASS-21) scale has 21 items with a 3 point likert scale. Range is 0-189 with higher scores indicating greater symptoms of depression, anxiety and stress.
Change in Baseline Caregiver Burden up to 36 weeks as assessed by the Zarit Burden Index
Time frame: Baseline through study completion up to 36 weeks
The Zarit Burden Index (ZBI-12) is a 12 Item questionnaire with 5 point likert scale. Range is 0-48 with higher scores indicating higher symptoms of caregiver burden.
Change in Baseline Caregiver Participation in Meaningful and Fulfilling Activities up to 36 weeks as assessed by the Engagement in Meaningful Activities Scale
Time frame: Baseline through study completion up to 36 weeks
The Engagement in Meaningful Activities Scale (EMAS) assesses the alignment between a person's actions/activities in daily life and their personal values. Increasing engagement in meaningful activities is a goal of ACT. This scale has 12 items with 5 point likert scale. Range is 12-72 with higher scores indicating higher (better) engagement in meaningful activities.
Change in Psychological Flexibility and Experiential Avoidance up to 36 weeks as assessed by the Acceptance and Action Questionnaire
Time frame: Baseline through study completion up to 36 weeks
The Acceptance and Action Questionnaire (AAQ-II) was developed to evaluate the effectiveness of ACT behavioural therapy, which aims to increase psychological flexibility and decrease experiential avoidance. Psychological flexibility refers to a person's ability to recognize and adapt to situational demands; shift perspectives, thinking or behaviours that reduce personal or social functioning; maintain balance among important life domains; and be aware, open, and committed to behaviors that align with personal values (Kashdan, 2010). The questionnaire includes 7 Items with a 7 point likert scale. Range is 7-49 with lower scores indicating higher (better) psychological flexibility and lower (better) experiential avoidance.
3 secondary outcomes
Acceptability of ACT Intervention Technology Used for Remote Delivery up to 36 weeks as assessed by the System Usability Scale
Time frame: Through study completion up to 36 weeks
Satisfaction with ACT Intervention Delivery, Content and Processes up to 36 weeks as assessed by the Client Satisfaction Questionnaire
Time frame: Through study completion up to 36 weeks
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
Time frame: Through study completion up to 1 year
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 3 May 2023.
- Derived from this study: PubMed 40353485Durepos P, Ricketts N, Olthuis JV, Gould ON, Boamah SA, McCloskey R, Lanteigne M, Giberson ER, Caverhill K, Pickford K, MacBean C, Kaasalainen S. Acceptance and Commitment Therapy Tele-Counselling Program With Care Partners of Persons Living With Dementia: A Pilot Feasibility RCT. J Appl Gerontol. 2026 Feb;45(2):225-236. doi: 10.1177/07334648251338303. Epub 2025 May 12.
- Individual participant dataSharing planned: No. No IPD will be shared with researchers outside of the study.
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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.
Pamela Durepos, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Intervention in people with Acceptance and Commitment Therapy and Caregiver Burden, run by University of New Brunswick 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 5 inclusion and 5 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 3 May 2023. 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 in Baseline Depression, Anxiety and Stress up to 36 weeks as assessed by the Depression, Anxiety and Stress Scale (time frame: Baseline through study completion up to 36 weeks). The study lists 4 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 NCT05385458, which also lists 1 linked publication.
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 3 May 2023.