Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth

January 3, 2024 updated by: Nova Scotia Health Authority

Feasibility of Delivering Group Cognitive Behavioral Therapy for Older Adults With Depression and Anxiety by Telehealth

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • Abbie J Lane Memorial Building - QEII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This will be completed at the end of the 8 week Telehealth CBT group.
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.
This will be completed at the end of the 8 week Telehealth CBT group.
Attrition to the Telehealth CBT group for older adults
Time Frame: 8 weeks
Attendance will be noted by group facilitators at each group session
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
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.
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
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.
Scales will be administered at baseline and at the end of the 8 weeks of group therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Christelle Boudreau, MD, NSHA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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