NCT04714164

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 7, 2021

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Telehealth CBT group for older adults

    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

    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

    Attendance will be noted by group facilitators at each group session

    8 weeks

Secondary Outcomes (3)

  • Effect size between pre-group and post-group questionnaires (anxiety)

    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)

    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)

    Scales will be administered at baseline and at the end of the 8 weeks of group therapy.

Study Arms (1)

Teletherapy Group CBT participants

EXPERIMENTAL

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

Interventions

Therapy will be delivered weekly for 8 weeks by Zoom.

Teletherapy Group CBT participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbie J Lane Memorial Building - QEII

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (13)

  • 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.

    PMID: 18479316BACKGROUND
  • 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.

    PMID: 29933137BACKGROUND
  • 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.

    PMID: 17535945BACKGROUND
  • 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.

    PMID: 30416025BACKGROUND
  • 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.

    PMID: 18254062BACKGROUND
  • 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.

    PMID: 31530457BACKGROUND
  • 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.

    PMID: 27354970BACKGROUND
  • 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.

    PMID: 12949851BACKGROUND
  • 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.

    PMID: 27087298BACKGROUND
  • 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.

    PMID: 27537217BACKGROUND
  • 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.

    PMID: 24501015BACKGROUND
  • 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.

    PMID: 26249300BACKGROUND
  • 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.

    PMID: 27486149BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorGeneralized Anxiety DisorderPhobia, SocialPanic Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAnxiety DisordersPhobic Disorders

Study Officials

  • Christelle Boudreau, MD

    NSHA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility and acceptability study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 19, 2021

Study Start

February 18, 2021

Primary Completion

March 9, 2022

Study Completion

September 15, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations