Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth
Primary Purpose
Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- People over the age of 65
- Diagnosis of either or both Major Depressive Disorder (MDD) of mild or moderate severity and an anxiety disorder, including generalized anxiety disorder, social anxiety disorder or panic disorder.
Exclusion Criteria:
- Patients with psychosis
- Patients with dementia
- Patient with severe Major Depressive Disorder or Anxiety Disorder
- Patients with antisocial or borderline personality disorder
- Patients with acute suicidal ideation.
- Older adults who do not have access to the technology required for group; computer, phone or tablet with a webcam and access to Internet
These are also exclusion criteria for the CBT group outside of the study. People younger than 65 are also excluded from the group because it is offered to older adults only.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teletherapy Group CBT participants
Arm Description
Patients over the age of 65 with either a Major Depressive Disorder or Generalized Anxiety Disorder who will be participating in a Group CBT delivered by Teletherapy
Outcomes
Primary Outcome Measures
Feasibility of Telehealth CBT group for older adults
This will be assessed by a questionnaire: System Usability Scale.
Acceptability of Telehealth CBT group for older adults
This will be measured by a questionnaire administered to participants titled Satisfaction Survey.
Attrition to the Telehealth CBT group for older adults
Attendance will be noted by group facilitators at each group session
Secondary Outcome Measures
Effect size between pre-group and post-group questionnaires (anxiety)
The following scale will be administered before and after completing the group to determine if there is any change in the result: Beck Anxiety Inventory.
Effect size between pre-group and post-group questionnaires (depression)
The following scale will be administered before and after completing the group to determine if there is any change in the result: Beck Depression Inventory.
Effect size between pre-group and post-group questionnaires (perceived quality of life)
The following scale will be administered before and after completing the group to determine if there is any change in the result: Perceived Quality of Life questionnaire.
Full Information
NCT ID
NCT04714164
First Posted
January 7, 2021
Last Updated
January 15, 2021
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT04714164
Brief Title
Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth
Official Title
Feasibility of Delivering Group Cognitive Behavioral Therapy for Older Adults With Depression and Anxiety by Telehealth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present aim of the study is to to adapt an established, manualized enhanced Group CBT (CBT-E) for seniors to a telehealth format, which will allow us to offer the group virtually during the COVID-19 pandemic.
Detailed Description
The goal of this project is to adapt an established, manualized enhanced Group CBT (CBT-E) for seniors to a telemedicine format. Currently the Geriatric Psychiatry service associated with the Nova Scotia Health Authority offer two CBT-E groups every year. They are usually facilitated by psychiatry residents, under the supervision of a staff psychiatrist. Due to the risk of COVID-19, we will not be holding in-person groups this year. Instead we will offer the group in a smaller, telemedicine format. For this project, we will change the group structure and activities to allow it's delivery in a virtual format. This study will assess feasibility, tolerability of the telehealth format by using the System Usability Scale and Group Satisfaction Survey. It will also assess response to online therapy buy using pre- and post-group questionnaires including the Beck Depression Inventory, Beck Anxiety Inventory and Perceived Quality of Life Questionnaire. Paired t-tests will be used to analyse the data and determine whether there has been an improvement in participant's symptoms and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility and acceptability study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teletherapy Group CBT participants
Arm Type
Experimental
Arm Description
Patients over the age of 65 with either a Major Depressive Disorder or Generalized Anxiety Disorder who will be participating in a Group CBT delivered by Teletherapy
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioral Therapy
Intervention Description
Therapy will be delivered weekly for 8 weeks by Zoom.
Primary Outcome Measure Information:
Title
Feasibility of Telehealth CBT group for older adults
Description
This will be assessed by a questionnaire: System Usability Scale.
Time Frame
This will be completed at the end of the 8 week Telehealth CBT group.
Title
Acceptability of Telehealth CBT group for older adults
Description
This will be measured by a questionnaire administered to participants titled Satisfaction Survey.
Time Frame
This will be completed at the end of the 8 week Telehealth CBT group.
Title
Attrition to the Telehealth CBT group for older adults
Description
Attendance will be noted by group facilitators at each group session
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect size between pre-group and post-group questionnaires (anxiety)
Description
The following scale will be administered before and after completing the group to determine if there is any change in the result: Beck Anxiety Inventory.
Time Frame
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
Title
Effect size between pre-group and post-group questionnaires (depression)
Description
The following scale will be administered before and after completing the group to determine if there is any change in the result: Beck Depression Inventory.
Time Frame
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
Title
Effect size between pre-group and post-group questionnaires (perceived quality of life)
Description
The following scale will be administered before and after completing the group to determine if there is any change in the result: Perceived Quality of Life questionnaire.
Time Frame
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People over the age of 65
Diagnosis of either or both Major Depressive Disorder (MDD) of mild or moderate severity and an anxiety disorder, including generalized anxiety disorder, social anxiety disorder or panic disorder.
Exclusion Criteria:
Patients with psychosis
Patients with dementia
Patient with severe Major Depressive Disorder or Anxiety Disorder
Patients with antisocial or borderline personality disorder
Patients with acute suicidal ideation.
Older adults who do not have access to the technology required for group; computer, phone or tablet with a webcam and access to Internet
These are also exclusion criteria for the CBT group outside of the study. People younger than 65 are also excluded from the group because it is offered to older adults only.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle Boudreau, MD
Phone
5068752816
Email
christelle.boudreau@nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Meagan MacNeil, MD
Phone
902-464-6032/902-456-3099
Email
Meagan.MacNeil@nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle Boudreau, MD
Organizational Affiliation
NSHA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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18479316
Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Links:
URL
https://www.canada.ca/en/employment-social-development/programs/seniors-action-report.html
Description
Government of Canada - Action for Seniors report. Published in fall 2014.
URL
https://www.multiculturalmentalhealth.ca/en/
Description
Center for Multicultural Mental Health Research 2012
URL
https://www.nice.org.uk/
Description
National Institute for Clinical Excellence. Depression: management of depression in primary and secondary care. NICE 2004.
Learn more about this trial
Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth
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