Online Delivery of Psychotherapy, Tailored to Patients' Suffering from Mental Health Problems Due to COVID-19

NCT04476667 | Completed

• 1 other identifier: PSIY-683-20
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The recent COVID-19 pandemic has affected many aspects of individuals social life and its negative consequences on Canadian public health go far beyond the direct overload of the hospital care system. Self-isolation and financial uncertainty can significantly deteriorate individuals' mental health, which is only going to aggravate with prolonged physical distancing strategies. Adding to this is the personal and public trauma of lost lives and soon there will be an unprecedented epidemic of mental health problems with crushing effects on the public health sector and economy. To meet this huge new demand for an already strained health system, there is a need for innovative new approaches that significantly expand the capacity of care delivery. While it may not be possible in the short term to increase the number of mental healthcare providers or the number of hours they work, improving their time spent efficiently might be the solution. Virtual care and online delivery of psychotherapy, shown to be clinically effective, efficient and cost-effective, might be the perfect solution to address the high demand faced now. The investigators aim to establish the first academic online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care delivery could increase care capacity by four-folds. The findings from this project have the potential to influence clinical practice and policy and increase accessibility to care during COVID-19 pandemic, without sacrificing the quality of care.

Conditions

Mental Health Issue; Covid19; Anxiety Disorders; Depression

Keywords

Anxiety; Depression; COVID-19; Online Psychotherapy; Mental Health

Outcome Measures

Primary Outcomes (6)

• Change in Stress

  The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)

  Baseline, week 6, week 12

• Change in Resilience

  14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)

  Baseline, week 6, week 12

• Change in Quality of Life Assessment

  The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)

  Baseline, week 6, week 12

• Change in Symptom Severity - 1

  Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

  Baseline, week 6, week 12

• Change in Symptom Severity - 2

  Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)

  Baseline, week 6, week 12

• Change in Symptom Severity - 3

  Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

  Baseline, week 6, week 12

Secondary Outcomes (2)

• Qualitative Information: Healthcare Providers

  Week 12

• Qualitative Information: Personal, social, and cultural factors

  Week 12

Study Arms (2)

e-Psychotherapy

EXPERIMENTAL

Participants will receive a 9-week program with CBT, mindfulness, and problem-based therapy, in addition to TAU. The content will be customized to reflect challenges faced through the COVID-19 pandemic and developed into interactive and engaging modules. All sessions and interactions will occur through Online Psychotherapy Tool (OPTT), a secure online platform. Participants will be assigned to a team of psychiatrists and social workers (SWs). The SW working with each patient will assign a pre-designed therapy module to that patient on a specific day of the week through OPTT. Participants will then be able to access the therapy content at any time throughout the week. Each module will highlight a different topic and include general information, an overview of skills, and homework that is to be completed by a specific day that week. This homework will be directly submitted through OPTT to the clinician who will provide personalized feedback to the patient.

Behavioral: e-Psychotherapy

Treatment as Usual

NO INTERVENTION

The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.

Interventions

e-Psychotherapy BEHAVIORAL

Module Content: The first 3 sessions will be designed to address the symptoms caused by fear of illness or concerns about personal safety in the context of pandemic. Electronic-CBT (e-CBT) modules will focus on problem solving techniques, with mindfulness practices included, to help build healthy coping skills to address the uncertainties surrounding the COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the connection between thoughts, behaviours, emotions, physical reaction and one's environment.

e-Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to consent
• Diagnosis of MDD and/or GAD
• Ability to speak and read English
• Consistent and reliable access to the internet

You may not qualify if:

• Active psychosis
• Acute mania
• Severe alcohol or substance use disorder
• Active suicidal or homicidal ideation
• Participant receiving another form of psychotherapy

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (2)

• Moghimi E, Stephenson C, Agarwal A, Nikjoo N, Malakouti N, Layzell G, O'Riordan A, Jagayat J, Shirazi A, Gutierrez G, Khan F, Patel C, Yang M, Omrani M, Alavi N. Efficacy of an Electronic Cognitive Behavioral Therapy Program Delivered via the Online Psychotherapy Tool for Depression and Anxiety Related to the COVID-19 Pandemic: Pre-Post Pilot Study. JMIR Ment Health. 2023 Dec 25;10:e51102. doi: 10.2196/51102.

  PMID: 37993984 DERIVED

• Alavi N, Yang M, Stephenson C, Nikjoo N, Malakouti N, Layzell G, Jagayat J, Shirazi A, Groll D, Omrani M, O'Riordan A, Khalid-Khan S, Freire R, Brietzke E, Gomes FA, Milev R, Soares CN. Using the Online Psychotherapy Tool to Address Mental Health Problems in the Context of the COVID-19 Pandemic: Protocol for an Electronically Delivered Cognitive Behavioral Therapy Program. JMIR Res Protoc. 2020 Dec 18;9(12):e24913. doi: 10.2196/24913.

  PMID: 33290245 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Nazanin Alavi

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Participants selected for the e-psychotherapy group will receive a 9-week program that includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU. The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: June 15, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)