- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04476667
Online Delivery of Psychotherapy, Tailored to Patients' Suffering From Mental Health Problems Due to COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants: Participants (n=80) aged 18-65 years will be recruited from referrals within the outpatient clinics of HDH and PCH. Participants who consent to take part in the study will be evaluated by one of the psychiatrists on the team through a video appointment. Diagnosis of MDD and/or GAD will be confirmed using the DSM-5 and approved through the M.I.N.I. The inclusion criteria for the study will include the capacity to consent; a diagnosis of MDD and/or GAD, the ability to speak and read English, and having consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. If a participant is receiving another form of psychotherapy, they will also be excluded from the study. If eligible for the study, participants will be randomly assigned to either the electronic psychotherapy (e-psychotherapy) or control (i.e. Treatment as usual (TAU)) group, stratified by sex, age group, and gender.
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 content of the e-psychotherapy program will be customized to reflect the challenges that individuals face through the COVID-19 pandemic and will be developed into interactive and engaging therapy modules. All online sessions and interactions will occur through Online Psychotherapy Tool (OPTT), a secure online platform.
Through OPTT, all 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 weekly 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. Completing each weekly module requires an average time commitment of 40-minutes, which can be completed at once or in blocks of time. This homework will be directly submitted through OPTT to the clinician who will then provide personalized feedback to the patient. To ensure a consistent high-quality outcome, SWs will use pre-designed session-specific feedback templates to respond to each weekly patient submission. Each patient's care team will be able to securely communicate through OPTT to make decisions regarding each patient's care path. 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.
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 a 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.
Training: Through training, all SWs will learn the standard care pathway, the aim, and the content of each therapeutic session. Moreover, they will be provided sample homework from a patient and asked to provide feedback. Feedback templates will vary from session to session and SWs will personalize each template for each patients' homework. Training will occur through webinars and exercises with feedback.
Outcome Evaluation: Primary outcomes measured will be stress level changes based on the DASS-21, resilience based on RS-14, and quality of life-based on Q-LES-Q. Additional measurements will be made based on participant diagnosis (PHQ9, MADRS, GAD7). All questionnaires will be collected directly through OPTT at baseline, session 6, after the final session, and at a 6-month follow up. Healthcare providers will be asked about the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to the participant, and any perceived benefits/drawbacks to e-psychotherapy. From focus groups, factors related to personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.
Ethics and Data Privacy: All procedures have been submitted for approval of ethical compliance to the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Only the care providers involved in the care of the participant will have access to their chart. Patients will only be identifiable by an ID number on the OPTT platform and their real identity and consent forms will be stored locally in a locked file cabinet and destroyed 5 years after the study completion date. Only anonymized data will be provided to the analysis team members.
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal privacy and security regulations are met. OPTT will not collect any identifiable personal information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata to improve its service quality and provide advanced analytics to the clinician team. All data is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups are kept in the S3 storage that is dedicated to Queen's University.
Data Analysis: Repeated MANOVA will be used to evaluate treatment efficacy in changes in scores on the DASS-21, RS-14 & Q-LES-Q between the participant groups (TAU, anxiety, and depression), and changes within each specific diagnosis at four different time points. Thematic analysis will be applied to analyze survey questions in order to better capture experiences, acceptability and patient-centeredness of e-psychotherapy. Descriptive analysis of time spent by each care team member for individual participants to evaluate the cost efficiency of care delivery will occur.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5G3
- Hotel Dieu Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capacity to consent
- Diagnosis of MDD and/or GAD
- Ability to speak and read English
- Consistent and reliable access to the internet
Exclusion Criteria:
- Active psychosis
- Acute mania
- Severe alcohol or substance use disorder
- Active suicidal or homicidal ideation
- Participant receiving another form of psychotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: e-Psychotherapy
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.
|
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.
|
No Intervention: Treatment as Usual
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stress
Time Frame: Baseline, week 6, week 12
|
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
Time Frame: Baseline, week 6, week 12
|
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
Time Frame: Baseline, week 6, week 12
|
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
Time Frame: Baseline, week 6, week 12
|
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
Time Frame: Baseline, week 6, week 12
|
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
Time Frame: Baseline, week 6, week 12
|
Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)
|
Baseline, week 6, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative Information: Healthcare Providers
Time Frame: Week 12
|
Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.
|
Week 12
|
Qualitative Information: Personal, social, and cultural factors
Time Frame: Week 12
|
In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy.
This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.
|
Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSIY-683-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Ethics and Data Privacy: Only care providers involved in care of participant will have access to charts. Patients will only be identifiable by ID number on OPTT platform and real identity and consent forms will be stored locally in locked file cabinet and destroyed 5 years after study completion date. Only anonymized data will be provided to analysis team members.
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal privacy and security regulations are met. OPTT will not collect any identifiable personal information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata to improve its service quality and provide advanced analytics to the clinician team. All data is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups are kept in the S3 storage that is dedicated to Queen's University.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Lawson Health Research InstituteTerminated
-
Federal Research Center of Fundamental and Translational...CompletedDepression Moderate | Depression MildRussian Federation
Clinical Trials on e-Psychotherapy
-
Queen's UniversityNot yet recruitingMental Health IssueCanada
-
Universitätsklinikum Hamburg-EppendorfCompleted
-
Universidade Federal do Rio de JaneiroCompleted
-
Randi UlbergUniversity of OsloCompleted
-
Hopital MontfortThe Ottawa HospitalCompletedDepression | Parkinson's DiseaseCanada
-
Marianne Lau, MD, DSci.The Ministry of Science, Technology and Innovation, DenmarkUnknownBulimia Nervosa (BN) | Binge Eating Disorder (BED) | Eating Disorder Not Otherwise Specified (EDNOS)Denmark
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Completed
-
University Hospital FreiburgCompletedChronic Major Depressive DisorderGermany
-
Centre Hospitalier Régional Metz-ThionvilleCentral Hospital, Nancy, France; University of LorraineCompletedBreast Cancer FemaleFrance
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityUnknown