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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04714164
Other study ID # 29243
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 18, 2021
Est. completion date September 15, 2023

Study information

Verified date January 2024
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date September 15, 2023
Est. primary completion date March 9, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Group Cognitive Behavioral Therapy
Therapy will be delivered weekly for 8 weeks by Zoom.

Locations

Country Name City State
Canada Abbie J Lane Memorial Building - QEII Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary Attrition to the Telehealth CBT group for older adults Attendance will be noted by group facilitators at each group session 8 weeks
Secondary 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. Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
Secondary 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. Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
Secondary 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. Scales will be administered at baseline and at the end of the 8 weeks of group therapy.
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