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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

Tracking Information
First Submitted Date  ICMJE January 7, 2021
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 19, 2021
Estimated Study Start Date  ICMJE February 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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.
  • 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.
  • Attrition to the Telehealth CBT group for older adults [ Time Frame: 8 weeks ]
    Attendance will be noted by group facilitators at each group session
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth
Official Title  ICMJE Feasibility of Delivering Group Cognitive Behavioral Therapy for Older Adults With Depression and Anxiety by Telehealth
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility and acceptability study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder
Intervention  ICMJE Behavioral: Group Cognitive Behavioral Therapy
Therapy will be delivered weekly for 8 weeks by Zoom.
Study Arms  ICMJE 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
Intervention: Behavioral: Group Cognitive Behavioral Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04714164
Other Study ID Numbers  ICMJE 29243
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Christelle Boudreau, Nova Scotia Health Authority
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nova Scotia Health Authority
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christelle Boudreau, MD NSHA
PRS Account Nova Scotia Health Authority
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP