An interventional study of iCBT in Major Depressive Disorder, Social Anxiety Disorder and Panic Disorder, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators hypothesize that patients who receive iCBT will show significant improvement in anxiety symptoms and functioning, compared to a wait-list group. This pilot randomized controlled study will assess the efficacy of transdiagnostic iCBT in 60 young adults.
Unipolar depression and anxiety disorders (particularly social anxiety disorder [SAD], generalized anxiety disorder [GAD] and panic disorder [PD]) are among the most common forms of mental illnesses. They often have a chronic course, and are frequently associated with co-morbidities, significant disability, and poor quality of life. Published epidemiologic studies indicate that these conditions typically emerge during early adolescence and adulthood, and are often poorly recognized, resulting in delay of several years before help is sought. Such delay is often attributed to the non-recognition of the significance of the symptoms, lack of information on or access to services, and embarrassment and fear of stigma, but each effective early treatment can reduce co-morbidities and improve prognosis.
Cognitive behaviour therapy (CBT) is recognized as the single most effective psychological intervention for depression and anxiety, but accessibility is affected by therapist costs and long wait times for OHIP-covered services. Internet-based CBT (iCBT) is an innovative alternative with higher accessibility and cost-efficiency than group CBT, but with comparable efficacy. Transdiagnostic models of iCBT that treat depression, SAD, PD and GAD within one program have shown efficacy in preliminary trials and may offer even greater accessibility and economy, as several depressed and anxious populations can be treated with the same protocol. As a non-pharmacological treatment option enhanced by technological advances, iCBT is likely to appeal to tech-savvy young adults. However, it has not been evaluated specifically in a young adult population, thus far.
This 8-week, multi-site, randomized, controlled trial to evaluate the benefits of trandiagnostic iCBT in 60 young adults with unipolar depression and/or SAD, PD or GAD. We hypothesize that patients who receive iCBT will show significant improvement in depressive and anxiety symptoms and functioning, compared to a wait-list group.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 77 is close to the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.
Behavioral: iCBT
Upon completion of the 8-week study wait-list period (i.e. their study participation), the opportunity to participate in iCBT, outside the study framework will be provided.
The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.
Also known as: Internet based Cognitive Behavioural Therapy
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Panic Disorder Severity Scale Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Penn State Worry Questionnaire Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Clinical Global Impression (CGI)
Time frame: Baseline to study endpoint (Week 8)
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health