Major Depressive DisorderNCT04714164

Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth

A study testing Group Cognitive Behavioral Therapy in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Nova Scotia Health Authority at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder
What is being tested?: Group Cognitive Behavioral Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteCanada
Study dates: 18 Feb 2021to 15 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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

Read the 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.

Conditions: Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
Being tested: Group Cognitive Behavioral Therapy
Medical subject headings: Depressive Disorder, Major, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04714164
Study group	Role	What they receive
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 Receives: Behavioral: Group Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Telehealth CBT group for older adults
This will be assessed by a questionnaire: System Usability Scale.
Measured: 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.
Measured: 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
Measured: 8 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202115 Sep 2023

First posted19 Jan 2021
Study start18 Feb 2021
Primary completion9 Mar 2022
Study completion15 Sep 2023

Why it stopped: We had difficulty with participation in the study for our initial Zoom CBT group.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Feasibility and acceptability study
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04714164
Sponsor's protocol ID: 29243
Status last verified: Jan 2024
First submitted: 7 Jan 2021
Last updated: 5 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18479316
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.
PubMed 29933137
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.
PubMed 17535945
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.
PubMed 30416025
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.
PubMed 18254062
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.
PubMed 31530457
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.
PubMed 27354970
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.
PubMed 12949851
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.
PubMed 27087298
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.
PubMed 27537217
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.
PubMed 24501015
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.
PubMed 26249300
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.
PubMed 27486149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Delivering Group Cognitive Behavioral Therapy for Older Adults With Depression and Anxiety by Telehealth
ClinicalTrials.gov ID: NCT04714164
Acronym / sponsor ID: 29243
Conditions: Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
Study type: Interventional
Recruitment status: TerminatedReason stopped: We had difficulty with participation in the study for our initial Zoom CBT group.
Enrolment: 5 participants (actual)
Lead sponsor: Nova Scotia Health AuthorityUniversity, hospital or other
Study start: 18 Feb 2021 (actual)
Primary completion: 9 Mar 2022 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 19 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Feasibility and acceptability study

Arm	Type	Receives
Teletherapy Group CBT participants	Experimental	Behavioral: Group Cognitive Behavioral TherapyPatients 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

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group Cognitive Behavioral TherapyTherapy will be delivered weekly for 8 weeks by Zoom.	Behavioural	Teletherapy Group CBT participants

Primary outcome

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

3 secondary outcomes

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.
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.
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.

Results and safety

The study was stopped early (reason given: We had difficulty with participation in the study for our initial Zoom CBT group.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Background: PubMed 18479316Hendriks 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.
Background: PubMed 29933137Tavares 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.
Background: PubMed 17535945O'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.
Background: PubMed 30416025Gentry 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.
Background: PubMed 18254062Wilson 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.
Background: PubMed 31530457Hantke 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.
Background: PubMed 27354970Hubley 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.
Background: PubMed 12949851Baldwin 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.
Background: PubMed 27087298Apostolo 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.
Background: PubMed 27537217Jonsson 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.
Background: PubMed 24501015Choi 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.
Background: PubMed 26249300Egede 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.
Government of Canada - Action for Seniors report. Published in fall 2014.Link provided by the sponsor.
Center for Multicultural Mental Health Research 2012Link provided by the sponsor.
Yalom, I.D., The Theory and Practice of Group Psychotherapy, 5th edition, Basic BooksLink provided by the sponsor.
National Institute for Clinical Excellence. Depression: management of depression in primary and secondary care. NICE 2004.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christelle Boudreau, MD principal investigator

NSHA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Behavioral Therapy in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: We had difficulty with participation in the study for our initial Zoom CBT group.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Telehealth CBT group for older adults (time frame: This will be completed at the end of the 8 week Telehealth CBT group.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04714164, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.