Bipolar Disorder (BD), Depression / Major Depressive Disorder
Conditions
Keywords
Cognitive behavioral therapy, Online treatment
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALOnline Cognitive Behavioural Therapy
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.
Sponsors
Dalhousie University
University of Michigan
Simon Fraser University
Ontario Shores Centre for Mental Health Sciences
University of Regina
University of Texas Southwestern Medical Center
University Health Network, Toronto
St. Joseph's Healthcare Hamilton
Nova Scotia Health Authority
The Canadian Biomarker Integration Network in Depression
Centre for Addiction and Mental Health
Ontario Brain Institute
McMaster University
Queen's University
University of Ottawa
University of British Columbia
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be deemed to have capacity to provide informed consent; 2. Must sign and date the informed consent form; 3. Stated willingness to comply with all study procedures; 4. 16 years of age or older; 5. Fluency in English; 6. Meet lifetime criteria for a bipolar or depressive disorder as defined by the DSM-5 and assessed in a previous CAN-BIND study; 7. Consent to the linkage of data to the previous CAN-BIND study
Exclusion criteria
1\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| Generalized Anxiety Disorder - 7 (GAD-7) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| Snaith-Hamilton Pleasure Scale (SHAPS) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| Work and Social Adjustment Scale (WSAS) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| The World Health Organization-Five Well-Being Index (WHO-5) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| Perseverative Thinking Questionnaire (PTQ) | Baseline, Week 8, Week 16, Week 24, Week 32 | 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. |
| Ruminative Response Scale (RRS) - Brooding Subscale | Baseline, Week 8, Week 16, Week 24, Week 32 | A 5-item measure of maladaptive rumination. Minimum score is 5 and Maximum score is 20, with higher scores indicating greater brooding. |
| Childhood Experience of Care and Abuse Questionnaire (CECA.Q) | Baseline | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORLena C. Lena, PhD
Centre for Addiction and Mental Health
Outcome results
None listed