Feasibility and Effectiveness of Delivering Cognitive Behaviour Therapy Through Online Psychotherapy Tool (OPTT) for Depression

Description

Patients (n=98) will be recruited from outpatient clinics at both Kingston Health Sciences Centre sites (Hotel Dieu Hospital and Kingston General Hospital) and Queen's University in Kingston. The sample size was determined by a power analysis to minimize the probability of a Type II error. This study will conduct six cycles of CBT and patients will be recruited over an 18-month period at a rate of 16 patients per cycle. The inclusion criteria for the study include the following: at least 16 years old at the start of the study, diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) by a clinician, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Informed consent (or where applicable, assent and parental consent) will be obtained at the beginning of the intake assessment and the patients will be given verbal and written instructions on how to participate in therapy through OPTT by the intake assessment administrator. All clinicians administering the e-CBT through OPTT will also be asked to provide informed consent prior to their patients in the study.

Procedure: In addition to a diagnosis of a DSM-V major depressive episode from an experienced clinician, recruited patients will be confirmed to meet the DSM-IV criteria for major depressive disorder using the Mini International Neuropsychiatric Interview (M.I.N.I. version 5.0.0) during an intake assessment conducted immediately after recruitment by the Project Manager or a trained research assistant. While this version of the M.I.N.I. has been validated for DSM-IV criteria, the criteria utilized for a major depressive episode has not changed from the DSM-IV to the DSM-V. Exclusion criteria include individuals with high current suicide risk (a score of over 17 points on section C, Suicidality, of the M.I.N.I.). The intake assessment (t0) consists of reviewing the letter of information, consent form, demographic information, M.I.N.I., and baseline questionnaires including the Depression Anxiety Stress Scale (DASS 21) and the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-QSF). Weekly sessions of CBT through OPTT will consist of approximately 30 slides and interactive therapist videos. The content and format of each weekly online session were designed to mirror the live CBT that will be occurring simultaneously and the efficacy of the 12 modules being used within the study in reducing depressive symptoms has already been tested through email administration by. The slides will highlight a different topic each week and include general information, an overview of skills, and homework on that topic. The homework included in each session will be submitted through OPTT and reviewed by the administrators with personalized feedback provided within three days of submission. Live CBT homework will be reviewed by the CBT group organizer and provided at the beginning of the next CBT session. Weekly homework submission for feedback will be mandatory before being eligible for the next session. DASS 21 and Q-LES-Q-SF questionnaires will be completed at the beginning and end of treatment for both live and e-CBT. Other quantitative measures for the e-CBT group will be gathered by extrapolating recorded information directly through the OPTT application (i.e., the number of logins per day, the amount of time spent logged in, etc.). After each cycle of e-CBT, patients and healthcare providers involved in e-CBT will be recruited for focus groups (8 for users and 2 for providers). Focus group participants will only be recruited after the completion of their 12-week e-CBT program. Qualitative data will be gathered through 10 focus groups, each focus group will consist of 8 patients. Numerous focus groups allow different perspectives to be captured including gender (male, female), age (under/over 30 years old), and discipline (patient, e-CBT administrator, and director). The focus group prompts will pertain to experience and expectations of service. Qualitative measure analyses will aid in the inquiry of the role of personal, social, and cultural factors in enabling or constraining the use of OPTT. Findings will identify factors related to the utility, feasibility, and accessibility of OPTT from the perspectives of users and providers. Interpretive qualitative methods are ideal for gathering in-depth descriptions of user experience and meaning. Focus groups conducted with medical residents will discuss the benefits of receiving training on and implementing e-CBT. An Interpretive Phenomenological Analysis (IPA) approach will guide data collection and analysis. The duration of most IPA focus groups is one hour. The semi-structured form asks questions followed by prompts in a personalized manner that may differ between groups. New perspectives may be introduced and explored. The IPA method is invaluable as it provides an inductive form of data collection and analysis. Focus groups are audio recorded and verbatim transcripts are coded in detail. All live and e-CBT patients will be contacted six months after the completion of their CBT to complete final DASS 21 and Q-LES-Q-SF questionnaires. This will allow for the examination of the longevity of e-CBT compared to live CBT.

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