Feasibility and Effectiveness of Delivering CBT Through OPTT for Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04478058|
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : May 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Live CBT Behavioral: e-CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be offered to take part in either live or online Cognitive Behavioural Therapy for a 12 week period.|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Effectiveness of Delivering Cognitive Behaviour Therapy Through Online Psychotherapy Tool (OPTT) for Depression|
|Actual Study Start Date :||June 1, 2019|
|Actual Primary Completion Date :||September 30, 2021|
|Actual Study Completion Date :||September 30, 2021|
Weekly e-CBT sessions will occur through Online Psychotherapy Tool (OPTT) and consist of slides and interactive therapist videos. Content and format mirrors live CBT. Slides will highlight a different topic each week and include general information, overview of skills, and homework. Homework will be submitted through OPTT and reviewed by administrators with personalized feedback within three days. Weekly homework submission will be mandatory before beginning the next session. DASS 21 and Q-LES-Q-SF questionnaires will be completed at the beginning and end of treatment. After each cycle of e-CBT, patients and healthcare providers involved in e-CBT will be recruited for focus groups once they have completed their 12-week program. Qualitative data will be gathered through 10 focus groups. The focus group prompts will pertain to experience and expectations of service. Patients will be contacted six months after treatment to complete DASS 21 and Q-LES-Q-SF questionnaires.
Weekly online Cognitive Behavioural Therapy
Active Comparator: Live CBT
The content and format of live CBT will be mirrored by the e-CBT group over the course of 12 weeks. The sessions will highlight a different topic each week and include general information, an overview of skills, and homework on that topic. 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. 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.
Behavioral: Live CBT
Weekly in-person Cognitive Behavioural Therapy
- Change in symptoms - Patient Health Questionnaire - 9 Item [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.
- Change in symptoms (Quick Inventory of Depressive Symptomatology) [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.
- Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire) [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]Clinical standardized symptom questionnaire. Scale of 1-5, 1 being the worst.
- Qualitative Analysis - Healthcare Provider Experience [ Time Frame: Week 12 (Post-Treatment) ]Focus groups for healthcare providers who will be asked about feasibility of providing the e-psychotherapy program, how it compares to in-person psychotherapy.
- Qualitative Analysis - Participant Experience [ Time Frame: Week 12 (Post-Treatment) ]Interviews with participants regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478058
|Kingston, Ontario, Canada, K7L 5G3|
|Principal Investigator:||Nazanin Alavi, MD FRCPC||Queen's University|