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Enrolling by invitation

NCT Number: NCT07783633

Identifying Biomarkers of Response to Digital Interventions for Mood Disorders

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.

Enrolling by invitation

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Key information

Conditions

Depression / Major Depressive Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar Disorder (BD) Bipolar and Related Disorders Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be deemed to have capacity to provide informed consent;
  • Must sign and date the informed consent form;
  • Stated willingness to comply with all study procedures;
  • 16 years of age or older;
  • Fluency in English;
  • Meet lifetime criteria for a bipolar or depressive disorder as defined by the DSM-5 and assessed in a previous CAN-BIND study;
  • Consent to the linkage of data to the previous CAN-BIND study

Exclusion criteria

  • Exclusion criteria for the current study include not meeting inclusion criteria only

Treatment and study plan

Online Cognitive Behavioural Therapy

Behavioral

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.

Other names: Wellbeing Course

Primary outcomes

  1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    Time frame: 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 outcomes

  1. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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.

  2. Generalized Anxiety Disorder - 7 (GAD-7)

    Time frame: 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.

  3. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: 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.

  4. Work and Social Adjustment Scale (WSAS)

    Time frame: 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.

  5. The World Health Organization-Five Well-Being Index (WHO-5)

    Time frame: 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.

  6. Perseverative Thinking Questionnaire (PTQ)

    Time frame: 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.

  7. Ruminative Response Scale (RRS) - Brooding Subscale

    Time frame: 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.

  8. Childhood Experience of Care and Abuse Questionnaire (CECA.Q)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Dalhousie University
  • McMaster University
  • Nova Scotia Health Authority
  • Ontario Brain Institute
  • Ontario Shores Centre for Mental Health Sciences
  • Queen's University
  • Simon Fraser University
  • St. Joseph's Healthcare Hamilton
  • The Canadian Biomarker Integration Network in Depression
  • University Health Network, Toronto
  • University of British Columbia
  • University of Calgary
  • University of Michigan
  • University of Ottawa
  • University of Regina
  • University of Texas Southwestern Medical Center

Registry information

Acronym: CAN-BIND-iCBT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 25, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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