non-inferiority rct comparing online and on-site cbt in mddi

Conditions: Major Depressive Disorder

Summary: in recent years, cognitive behavioral therapy has been integrated with mindfulness meditation (cbt-m) following evidence for increased efficacy when modalities are combined. we will assess whether online group cbt-m plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group cbt-m (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (mdd). this non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.

depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. cognitive behavioural therapy (cbt) is the best-evidenced treatment for depression, but despite demonstrated efficacy, many individuals cannot access adequate psychotherapeutic treatment due to the limitations of face-to-face delivery. in recent years, cbt has been integrated with mindfulness meditation (cbt-m) following strong evidence for increased efficacy when the two modalities are combined. previous rcts have demonstrated that online cbt-m is effective in depressive symptom reduction, but direct comparisons to in-office cbt delivery assessing cost and treatment outcomes are required to facilitate innovation and clinical policy change. objectives: to assess whether online group cbt-m plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group cbt-m (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults diagnosed with major depressive disorder (mdd). the study will assess whether digitally recorded adherence data (i.e. online workbooks completed, fitbit tracked step count, online text-messages exchanged, phone sessions completed) predict outcome benefits in the online-group participants as measured by changes in depressive symptoms. methods: this single-centre, 2-arm non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation. the research site is the centre for addiction and mental health (camh), a large research-based psychiatry institution located in toronto, canada. participants will be identified from wait-lists for camh services and through contacts with other toronto outpatient clinics. interventions: all participants will receive standard psychiatric care (1 pharmacotherapy focused visit/month with a psychiatrist of 15-30 minute duration). experimental participants additionally receive online cbt-m while control participants receive standard care in-office group cbt-m. the online group cbt-m program (in collaboration with nexj health, inc.) combines exposure to smartphone and computer accessed workbooks with phone-based mental health counselling (16 hours in 16 weeks) that coordinates with ongoing software interactions (e.g. secure text messaging, fitbit tracked walking). each participant is loaned a fitbit-hr charge 3 to assess physical activity as measured by daily step count.

Eligibility criteria:
inclusion criteria: * beck depression inventory-ii of at least mild severity (bdi-ii score ≥ 14) with no upper severity limit; * psychiatrist diagnosis of major depression disorder; * mini-international neuropsychiatric interview (mini)-confirmed diagnosis of major depression disorder; * fluent in english. exclusion criteria: * individuals currently receiving weekly structured psychotherapy; * individuals who meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder; * individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months); * individuals who are judged to have treatment resistant depression (trd), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode

Keywords: internet-based intervention major depressive disorder health coaching