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Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth

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ClinicalTrials.gov Identifier: NCT04714164
Recruitment Status : Unknown
Verified January 2021 by Christelle Boudreau, Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Christelle Boudreau, Nova Scotia Health Authority

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Behavioral: Group Cognitive Behavioral Therapy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility and acceptability study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Delivering Group Cognitive Behavioral Therapy for Older Adults With Depression and Anxiety by Telehealth
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Teletherapy Group CBT participants
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
 Behavioral: Group Cognitive Behavioral Therapy
Therapy will be delivered weekly for 8 weeks by Zoom.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of Telehealth CBT group for older adults [ Time Frame: This will be completed at the end of the 8 week Telehealth CBT group. ]
    This will be assessed by a questionnaire: System Usability Scale.

  2. Acceptability of Telehealth CBT group for older adults [ Time Frame: This will be completed at the end of the 8 week Telehealth CBT group. ]
    This will be measured by a questionnaire administered to participants titled Satisfaction Survey.

  3. Attrition to the Telehealth CBT group for older adults [ Time Frame: 8 weeks ]
    Attendance will be noted by group facilitators at each group session


Secondary Outcome Measures :
  1. Effect size between pre-group and post-group questionnaires (anxiety) [ Time Frame: Scales will be administered at baseline and at the end of the 8 weeks of group therapy. ]
    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.

  2. Effect size between pre-group and post-group questionnaires (depression) [ Time Frame: Scales will be administered at baseline and at the end of the 8 weeks of group therapy. ]
    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.

  3. Effect size between pre-group and post-group questionnaires (perceived quality of life) [ Time Frame: Scales will be administered at baseline and at the end of the 8 weeks of group therapy. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714164


Contacts
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Contact: Christelle Boudreau, MD 5068752816 christelle.boudreau@nshealth.ca
Contact: Meagan MacNeil, MD 902-464-6032/902-456-3099 Meagan.MacNeil@nshealth.ca

Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Christelle Boudreau, MD NSHA
More Information
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Additional Information:

Publications:

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Responsible Party: Christelle Boudreau, Psychiatry resident, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04714164    
Other Study ID Numbers: 29243
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Panic Disorder
 Phobia, Social
Pathologic Processes
Mental Disorders
Mood Disorders
Phobic Disorders