The proposed study will be a single-arm pragmatic clinical trial examining the feasibility of online CBT within the CAN-BIND sites and the biomarkers of treatment response to online CBT for mood disorders.
A total of 200 participants from the Canadian Biomarker Integration Network in Depression (CAN-BIND) network research sites will receive access to the Wellbeing Course for 8 Weeks with a 6-month follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The Wellbeing course is an online program that educates and guides users in cognitive behavioural therapy techniques with downloadable guides, client stories and interactive exercises to help manage symptoms of mood concerns.
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
A widely used and well-validated, 16-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Patient Health Questionnaire - 9 (PHQ-9)
A widely used and well-validated, 9-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Generalized Anxiety Disorder - 7 (GAD-7)
A widely used and well-validated, 7-item measure of symptoms of anxiety. Minimum score is 0 and Maximum score is 21, with higher scores indicating severe anxiety.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Snaith-Hamilton Pleasure Scale (SHAPS)
A widely used and well-validated 14-item measure of the ability to experience pleasure. Minimum score is 0 and Maximum score is 14, with higher scores indicating greater pleasure.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Work and Social Adjustment Scale (WSAS)
A 5-item measure of the impact of mental health conditions on daily functioning. Minimum score is 0 and Maximum score is 40, with higher scores indicating greater impairment in overall functioning.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
The World Health Organization-Five Well-Being Index (WHO-5)
A 5-item short form of quality of life across multiple domains. Raw scores range from 0 to 25 and can be converted to a percentage score ranging from 0 to 100, with higher scores indicating better mental well-being.
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Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Perseverative Thinking Questionnaire (PTQ)
A 15-item measure that assesses the underlying process of repetitive negative thinking, independent of specific thought content or diagnostic category. Minimum score is 0 and Maximum score is 60, with higher score indicating more frequent and intrusive negative thought patterns.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Ruminative Response Scale (RRS) - Brooding Subscale
A 5-item measure of maladaptive rumination. Minimum score is 5 and Maximum score is 20, with higher scores indicating greater brooding.
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Childhood Experience of Care and Abuse Questionnaire (CECA.Q)
A self-report measure assessing negative childhood experiences before age 17, including Neglect and Abuse. Sub-scale scores are derived by summing relevant items, with established cut-offs for severity of Neglect, Antipathy, Physical and Sexual abuse. Minimum score for Antipathy or Neglect is 8 and Maximum score is 40. A cutoff of \>=25 for severity of Antipathy mother/father while cutoff for severity of Neglect is \>=22 for mother and \>=24 for father. Minimum score for severity of Physical abuse is 0 and Maximum score is 4. Minimum score for severity of Sexual abuse is 0 and Maximum score is 7. The cutoff for severity of Physical and Sexual abuse is \>=1. Higher scores across all subscales (Antipathy, Neglect, Physical abuse, Sexual abuse) indicates greater severity. Loss and Support are also reported in this measure and scored as present or absent. Loss reflects parental death before age 17 or separation of 1+ year while Support reflects presence of at least one support figure.
Time frame: Baseline