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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
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 7, 2021
    Last Updated
    January 15, 2021
    Sponsor
    Nova Scotia Health Authority
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    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:
    PubMed Identifier
    18479316
    Citation
    Hendriks GJ, Oude Voshaar RC, Keijsers GP, Hoogduin CA, van Balkom AJ. Cognitive-behavioural therapy for late-life anxiety disorders: a systematic review and meta-analysis. Acta Psychiatr Scand. 2008 Jun;117(6):403-11. doi: 10.1111/j.1600-0447.2008.01190.x.
    Results Reference
    background
    PubMed Identifier
    29933137
    Citation
    Tavares LR, Barbosa MR. Efficacy of group psychotherapy for geriatric depression: A systematic review. Arch Gerontol Geriatr. 2018 Sep-Oct;78:71-80. doi: 10.1016/j.archger.2018.06.001. Epub 2018 Jun 18.
    Results Reference
    background
    PubMed Identifier
    17535945
    Citation
    O'Reilly R, Bishop J, Maddox K, Hutchinson L, Fisman M, Takhar J. Is telepsychiatry equivalent to face-to-face psychiatry? Results from a randomized controlled equivalence trial. Psychiatr Serv. 2007 Jun;58(6):836-43. doi: 10.1176/ps.2007.58.6.836.
    Results Reference
    background
    PubMed Identifier
    30416025
    Citation
    Gentry MT, Lapid MI, Rummans TA. Geriatric Telepsychiatry: Systematic Review and Policy Considerations. Am J Geriatr Psychiatry. 2019 Feb;27(2):109-127. doi: 10.1016/j.jagp.2018.10.009. Epub 2018 Oct 30.
    Results Reference
    background
    PubMed Identifier
    18254062
    Citation
    Wilson KC, Mottram PG, Vassilas CA. Psychotherapeutic treatments for older depressed people. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004853. doi: 10.1002/14651858.CD004853.pub2.
    Results Reference
    background
    PubMed Identifier
    31530457
    Citation
    Hantke N, Lajoy M, Gould CE, Magwene EM, Sordahl J, Hirst R, O'Hara R. Patient Satisfaction With Geriatric Psychiatry Services via Video Teleconference. Am J Geriatr Psychiatry. 2020 Apr;28(4):491-494. doi: 10.1016/j.jagp.2019.08.020. Epub 2019 Aug 24.
    Results Reference
    background
    PubMed Identifier
    27354970
    Citation
    Hubley S, Lynch SB, Schneck C, Thomas M, Shore J. Review of key telepsychiatry outcomes. World J Psychiatry. 2016 Jun 22;6(2):269-82. doi: 10.5498/wjp.v6.i2.269. eCollection 2016 Jun 22.
    Results Reference
    background
    PubMed Identifier
    12949851
    Citation
    Baldwin RC, Anderson D, Black S, Evans S, Jones R, Wilson K, Iliffe S; Faculty of Old Age Psychiatry Working Group, Royal College of Psychiatrists. Guideline for the management of late-life depression in primary care. Int J Geriatr Psychiatry. 2003 Sep;18(9):829-38. doi: 10.1002/gps.940.
    Results Reference
    background
    PubMed Identifier
    27087298
    Citation
    Apostolo J, Bobrowicz-Campos E, Rodrigues M, Castro I, Cardoso D. The effectiveness of non-pharmacological interventions in older adults with depressive disorders: A systematic review. Int J Nurs Stud. 2016 Jun;58:59-70. doi: 10.1016/j.ijnurstu.2016.02.006. Epub 2016 Feb 17.
    Results Reference
    background
    PubMed Identifier
    27537217
    Citation
    Jonsson U, Bertilsson G, Allard P, Gyllensvard H, Soderlund A, Tham A, Andersson G. Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness. PLoS One. 2016 Aug 18;11(8):e0160859. doi: 10.1371/journal.pone.0160859. eCollection 2016.
    Results Reference
    background
    PubMed Identifier
    24501015
    Citation
    Choi NG, Marti CN, Bruce ML, Hegel MT, Wilson NL, Kunik ME. Six-month postintervention depression and disability outcomes of in-home telehealth problem-solving therapy for depressed, low-income homebound older adults. Depress Anxiety. 2014 Aug;31(8):653-61. doi: 10.1002/da.22242. Epub 2014 Feb 5.
    Results Reference
    background
    PubMed Identifier
    26249300
    Citation
    Egede LE, Acierno R, Knapp RG, Lejuez C, Hernandez-Tejada M, Payne EH, Frueh BC. Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial. Lancet Psychiatry. 2015 Aug;2(8):693-701. doi: 10.1016/S2215-0366(15)00122-4. Epub 2015 Jul 16.
    Results Reference
    background
    PubMed Identifier
    27486149
    Citation
    MacQueen GM, Frey BN, Ismail Z, Jaworska N, Steiner M, Lieshout RJ, Kennedy SH, Lam RW, Milev RV, Parikh SV, Ravindran AV; CANMAT Depression Work Group. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 6. Special Populations: Youth, Women, and the Elderly. Can J Psychiatry. 2016 Sep;61(9):588-603. doi: 10.1177/0706743716659276. Epub 2016 Aug 2. Erratum In: Can J Psychiatry. 2017 May;62(5):356.
    Results Reference
    background
    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.

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    Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth

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