Published on in Vol 8, No 7 (2019): July

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/11591, first published .
An Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth Diagnosed With Major Depressive Disorders: Protocol for a Randomized Controlled Trial

An Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth Diagnosed With Major Depressive Disorders: Protocol for a Randomized Controlled Trial

An Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth Diagnosed With Major Depressive Disorders: Protocol for a Randomized Controlled Trial

Protocol

1School of Kinesiology and Health Science, York University, Toronto, ON, Canada

2Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada

3THETA and Biostatistics Unit, University Health Network, Toronto, ON, Canada

4Campbell Family Mental Health Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada

5Aboriginal Engagement and Outreach, Centre for Addiction and Mental Health, Toronto, ON, Canada

6Child and Youth Services, Centre for Addiction and Mental Health, Toronto, ON, Canada

7Department of Psychiatry, University of Toronto, Toronto, ON, Canada

8Centre for Addiction and Mental Health, Toronto, ON, Canada

9Mood and Anxiety Services, Centre for Addiction and Mental Health, Toronto, ON, Canada

10Department of Psychology, York University, Toronto, ON, Canada

*these authors contributed equally

Corresponding Author:

Paul Ritvo, PhD

School of Kinesiology and Health Science

York University

Bethune Building

4700 Keele St

Toronto, ON, M3J 1P3

Canada

Phone: 1 4165808021

Email: pritvo@yorku.ca


Background: About 70% of all mental health disorders appear before the age of 25 years. When untreated, these disorders can become long-standing and impair multiple life domains. When compared with all Canadian youth (of different ages), individuals aged between 15 and 25 years are significantly more likely to experience mental health disorders, substance dependencies, and risks for suicidal ideation and death by suicide. Progress in the treatment of youth, capitalizing on their online responsivity, can strategically address depressive disorders.

Objective: We will conduct a randomized controlled trial to compare online mindfulness-oriented cognitive behavioral therapy (CBT-M) combined with standard psychiatric care versus psychiatric care alone in youth diagnosed with major depressive disorder. We will enroll 168 subjects in the age range of 18 to 30 years; 50% of subjects will be from First Nations (FN) backgrounds, whereas the other 50% will be from all other ethnic backgrounds. There will be equal stratification into 2 intervention groups (INT1 and INT2) and 2 wait-list control groups (CTL1 and CTL2) with 42 subjects per group, resulting in an equal number of INT1 and CTL1 of FN background and INT2 and CTL2 of non-FN background.

Methods: The inclusion criteria are: (1) age 18 to 30 years, FN background or other ethnicity; (2) Beck Depression Inventory (BDI)-II of at least mild severity (BDI-II score ≥14) and no upper limit; (3) Mini-International Neuropsychiatric Interview (MINI)–confirmed psychiatric diagnosis of major depressive disorder; and (4) fluent in English. All patients are diagnosed by a Centre for Addiction and Mental Health psychiatrist, with diagnoses confirmed using the MINI interview. The exclusion criteria are: (1) individuals receiving weekly structured psychotherapy; (2) individuals who meet the Diagnostic and Statistical Manual of Mental Disorders criteria for severe alcohol/substance use disorder in the past 3 months, or who demonstrate clinically significant suicidal ideation defined as imminent intent, or who have attempted suicide in the past 6 months; and (3) individuals with comorbid diagnoses of borderline personality, schizophrenia, bipolar disorder, and/or obsessive compulsive disorder. All subjects are provided standard psychiatric care defined as 1 monthly session that focuses on appropriate medication, with session durations of 15 to 30 min. Experimental subjects receive an additional intervention consisting of the CBT-M online software program (in collaboration with Nex J Health, Inc). Exposure to and interaction with the online workbooks are combined with navigation-coaching delivered by phone and secure text message interactions.

Results: The outcomes selected, combined with measurement blinding, are key features in assessing whether significant benefits regarding depression and anxiety symptoms occur.

Conclusions: If results confirm the hypothesis that youth can be effectively treated with online CBT-M, effective services may be widely delivered with less geographic restriction.

International Registered Report Identifier (IRRID): PRR1-10.2196/11591

JMIR Res Protoc 2019;8(7):e11591

doi:10.2196/11591

Keywords



A total of 70% of all mental health problems appear before the age of 25 years. If untreated, these problems can become long-standing disorders that impair multiple life domains [1]. When compared with all Canadian youth (of different ages), the cohort between 15 and 25 years is significantly more likely to experience mental health disorders and substance dependencies and risks for suicidal ideation and death by suicide [2-5]. The current economic costs of mental health are vast, estimated at Can $51 billion annually, with Can $20.7 billion annually due to lost labor force participation [6]. Innovations in internet and smartphone technologies provide opportunities to deliver mental health care in ways that improve outcomes, reduce costs and overcome the geographic barriers that obstruct service equity.

Cognitive behavioral therapy (CBT)—the best-validated psychotherapy [7]—has, in recent years, been integrated with mindfulness meditation (MM), resulting in strong evidence supporting their combined effectiveness [8-14]. Research with this combination, with student populations, by our group, has resulted in psychometric and neurophysiological [9-17] benefits in online single-arm and randomized controlled trials (RCTs). Another online intervention, tested in an RCT, demonstrated significant reductions in glycosylated hemoglobin blood levels in patients with type 2 diabetes [18-20].

Mindfulness interventions gained notice due to the efficacy and low costs of easily learned procedures that fostered attentional skills and present-time awareness ([21-31]; Kirk et al, in press). For over three decades, in-person mindfulness-based stress reduction and acceptance and commitment therapy programs [17-24,32] have reduced mental and physical symptoms, summating in a significant accumulation of evidence supporting their effectiveness in nonclinical [28] and clinically diagnosed populations [29-31]. A recent review of mindfulness-based cognitive behavioral therapy (CBT-M) suggests that internet-based approaches have effects similar to in-person approaches [33] with evidential support from a systematic review of studies published between 2000 and 2018 [33-43]. The reviewed studies (all RCTs) assessed internet-delivered CBT-M programs in terms of changes in anxiety and depression (as primary or secondary outcomes) in adults (mean age ≥18 years) with a clinical diagnosis of depression or anxiety (using the Diagnostic and Statistical Manual [DSM]-IV protocol) [34-43]. In this review of 11 RCTs, a mean Hedges’ g of −0.47 was calculated based on a 45.6% reduction in depression symptoms when compared with the control populations. These reductions are similar to those found in a systematic review reported by Karyotaki et al who calculated a mean Hedges’ g of −0.27 (for depressive symptom reduction) in online, self-guided treatments that solely implemented CBT [44].

Online programs, altogether, can track usage and transmit text or email prompts to motivate adherence, resulting in higher motivation levels [45-48]. Access to a virtual mindfulness-based navigator-coach at greater frequencies than possible with face-to-face communication [45-49], and improved outcomes. The RCT described here combines these features and assesses them with youth with diagnosed major depressive disorders.


Aim

The study aims to evaluate the efficacy of CBT combined with MM to treat youth (aged 18-30 years) diagnosed with major depressive disorder. We will enroll 168 subjects, where 50% of the subjects will be from First Nations (FN) background, while the other 50% will be from all other ethnic backgrounds, stratified in 2 intervention groups and 2 (wait-list) control groups (42 subjects per group, where INT1 and CTL1 are from FN background and INT2 and CTL2 are from non-FN background). The intervention groups will be compared with the control groups at baseline, 3 months (mid intervention), and 6 months (post intervention), using validated outcome measures.

Recruitment and Randomization

Subjects are identified from the wait-lists for services at the Centre for Addiction and Mental Health (CAMH) and through contacts with multiple Toronto-based clinics. Eligible patients interact with a research coordinator who reviews and explains the study. Eligibility is ascertained in person followed by written consent before randomization. The identification of most subjects follows CAMH procedures where research coordinators identify potential participants by prescreening new clinic referrals and notifying the investigative team and the client’s clinician about potential study eligibility. The clinician then asks the client if she/he is willing to meet with a study team member to explore participation. Only when a client agrees, is she/he approached.

A biostatistician at the Department of Biostatistics at University Health Network (G Tomlinson) performed an electronic randomization of participants with study IDs to the different groups (INT1, INT2, CTL1, and CTL2). The information regarding each study ID with its respective group allocation was transferred onto cards and placed in individually sealed envelopes. After a participant had completed the baseline questionnaires, the research coordinator opened the next envelope in the series to determine participant group allocation and their respective study ID.

On the basis of a careful review of previously successful studies [38,39,41], we determined a sample size of 42 participants per group in 4 groups (total of n=168). Type I error was set at alpha=.05 and power at 80%. Our projected sample size of 168 participants is deemed more than adequate for the detection of small to medium effect size. With an anticipated drop-out rate of up to 20%, we will recruit 208 participants (54 per group).

Inclusion Criteria

The inclusion criteria are as follows: (1) age 18 to 30 years, FN background or any other ethnicity; (2) Beck Depression Inventory (BDI)-II of at least mild severity but no upper limit (BDI-II score ≥14) [50]; (3) Mini-International Neuropsychiatric Interview (MINI)-confirmed psychiatric diagnosis of major depressive disorder [51]; and (4) fluent in English. All patients are diagnosed by a CAMH physician, and the diagnoses are confirmed using the MINI interview administered at the screening visit [51].

Exclusion Criteria

The exclusion criteria are: (1) individuals who are currently receiving weekly structured psychotherapy; (2) individuals who meet the DSM-V criteria for severe alcohol/substance use disorder in the past 3 months, or who demonstrate clinically significant suicidal ideation defined as imminent intent, or who have attempted suicide in the past 6 months; and (3) individuals with comorbid diagnoses of borderline personality, bipolar disorder, schizophrenia, and/or obsessive compulsive disorder.

Intervention

All subjects are provided standard psychiatric care, involving 1 monthly session that focuses on appropriate medication, with session durations from 15 to 30 min. Experimental subjects receive the additional intervention, consisting of a CBT-M software program (in collaboration with Nex J Health, Inc), which is accessed online. Interactions with the online workbooks is combined with navigation-coaching (total 24 hours duration), primarily delivered in phone and text message interactions. In addition, each participant is given a Fitbit-HR Charge 2 that assesses physical steps and 24-hour heart rate in 5-second (averaged) durations (the software permits daily monitoring). The intervention content builds on 2 prior successful Web-based CBT-mindfulness RCTs with students [9,10,13,15-17] and on effective methods with other populations demonstrated in previous RCTs [52-55]. The online workbook content includes 24 chapters reflecting multiple topics (eg, Living By Your Truths, Overcoming Wired-ness and Tired-ness, Mindfulness and Relationships, Loss and Grief, and Resilience, Befriending Ourselves, Befriending Your Body with Exercise, Body Image and Mindfulness, Intimacy, Forgiveness, Overcoming Procrastination, Dealing with Negative Moods, Stress Resilience, Overcoming Performance Anxiety, and Cultivating Inspiration) covered sequentially on a weekly basis with the navigator-coach. In summary, the key intervention features are 24-hour access and CBT-mindfulness contents that address specific symptoms and generic depressive experiences.

Hypothesis

The CBT-M online intervention will be associated with statistically and clinically significant between-group differences (benefits) when treatment groups and control groups are compared, using both intention-to-treat (ITT) and per protocol analyses (PP). The ITT will proceed in a standard manner, whereas the PP will be based on the 24-week and 24-session structure of the intervention. All subjects who fail to attend 50% of the sessions (ie, <12 sessions) will be excluded from the PP.

Outcome Measures

Primary Outcome

The primary outcome measure is the BDI-II [50].

Secondary Outcomes

The secondary outcomes assess anxiety (Beck Anxiety Inventory) [56], depression (ie, Quick Inventory of Depressive Symptomatology) [57], 24-item Hamilton Depression Rating Scale (HDRS-24; with a blinded interview-rater) [58], mindfulness (5-Facet Mindfulness Questionnaire) [59], and pain (Brief Pain Inventory) [60].

All self-report measures and the HDRS-24 interview are carried out at the same CAMH Mood and Anxiety research clinic in identical assessment rooms. The HDRS-24 interview-rater is blinded to intervention and control conditions for the trial duration.


Analyses

Data obtained from participants during the study visits are de-identified and stored as electronic case reporting forms (CRFs) on the CAMH REDCap system and physical CRF paper copies in a locked cabinet. Participant characteristics are summarized via descriptive statistics. Group equivalence at baseline in terms of demographic and clinical variables is assessed.

Primary and Secondary Outcomes

The monthly rate of recruitment is calculated and the level of retention will be presented in the proportion of enrolled participants completing study outcomes at each time point.

The effect of the intervention on the primary clinical and secondary outcomes will be assessed through separate analysis of covariance (ANCOVA) models that have changed from baseline to 6 months as the dependent variable, the baseline value of the outcome as a covariate and the group assignment as a categorical variable. The treatment effect, its effect size (Hedges’ g), and 95% CIs for the treatment effect and within-group changes from baseline to one year will be calculated from the ANCOVA model. The sensitivity of results to missing data will be evaluated by running a purely data-based multiple imputation procedure, as well as the imputation of missing values on a case-by-case basis using expert opinion and patient history.


If hypothesized results are obtained, this intervention may be an important option for depressed youth. As it can be accessed wherever internet-based services are available, geographic barriers to high-quality treatment could be minimized. Acknowledged study limitations include the lack of blinding regarding administration of self-report measures other than the blinding maintained for the HDRS-24 assessment.

Conflicts of Interest

None declared.

References

  1. Public Health Agency of Canada. Ottawa, Ontario: Government of Canada; 2006. The human face of mental health and mental illness in Canada 2006   URL: http://www.phac-aspc.gc.ca/publicat/human-humain06/pdf/human_face_e.pdf [accessed 2019-04-18] [WebCite Cache]
  2. Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol 2000 May;55(5):469-480. [Medline]
  3. Arnett J. Emerging adulthood: the winding road from the late teens through the twenties. New York: Oxford University Press; 2004.
  4. Canadian Mental Health Association. 2015. Mental Health and High School Curriculum Guide   URL: http://www.cmha.ca/mental_health/mental-health-and-high-school-curriculum-guide/#.VVcDuVVViko [accessed 2019-04-18] [WebCite Cache]
  5. Lunau K. Macleans Magazine. 2012 Sep 05. The Mental Health Crisis on Campus   URL: https://www.macleans.ca/education/uniandcollege/the-mental-health-crisis-on-campus/ [accessed 2019-04-18] [WebCite Cache]
  6. The Conference Board of Canada. Mental Health Issues in the Labour Force: Reducing the Economic Impact on Canada   URL: https://www.conferenceboard.ca/e-library/abstract.aspx?did=4957&AspxAutoDetectCookieSupport=1 [accessed 2019-04-18] [WebCite Cache]
  7. Hofmann S, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry 2008 Apr;69(4):621-632 [FREE Full text] [Medline]
  8. Sipe W, Eisendrath S. Mindfulness-based cognitive therapy: theory and practice. Can J Psychiatry 2012 Feb;57(2):63-69. [CrossRef] [Medline]
  9. Ritvo P, Vora K, Irvine J, Mongrain M, Azam A, Azargive S, et al. Reductions in negative automatic thoughts in students attending mindfulness tutorial predicts increase life satisfaction. Int J Educ Psychol 2013 Oct;2(3):272-296. [CrossRef]
  10. Azam A, Ritvo P, Vora K, Pirbaglou M, Azargive S, Changoor T, et al. Mindfulness as an alternative for supporting university student mental health: cognitive emotional and depressive self criticism measures. Int J Educ Psychol 2016 Jun 24;5(2):140-163. [CrossRef]
  11. Guglietti C, Daskalakis ZF, Radhu N, Fitzgerald PB, Ritvo P. Meditation-related increases in GABAB modulated cortical inhibition. Brain Stimul 2013 May;6(3):397-402. [CrossRef] [Medline]
  12. Radhu N, Daskalakis Z, Guglietti C, Farzan F, Barr M, Arpin-Cribbie C, et al. Cognitive behavioral therapy-related increases in cortical inhibition in problematic perfectionists. Brain Stimul 2012 Jan;5(1):44-54. [CrossRef] [Medline]
  13. Radhu N, Daskalakis ZJ, Arpin-Cribbie CA, Irvine J, Ritvo P. Evaluating a web-based cognitive-behavioral therapy for maladaptive perfectionism in university students. J Am Coll Health 2012;60(5):357-366. [CrossRef] [Medline]
  14. Coelho H, Canter PH, Ernst E. Mindfulness-based cognitive therapy: evaluating current evidence and informing future research. J Consult Clin Psychol 2007 Dec;75(6):1000-1005. [CrossRef] [Medline]
  15. Arpin-Cribbie CA, Irvine MJ, Ritvo P. Web-based cognitive-behavioral therapy for perfectionism: a randomized controlled trial. Psychother Res 2012;22(2):194-207. [CrossRef] [Medline]
  16. Fashler S, Ashfaq I, Azam MA, Azargive S, Changoor T, Pirbaglou M, et al. Brief Summary of the Inaugural 12 Day Mindfulness Challenge. The Canadian Clinical Psychologist 2015 Apr;25(2):30 [FREE Full text]
  17. Azam MA, Katz J, Fashler S, Changoor T, Azargive S, Ritvo P. Heart rate variability is enhanced in controls but not maladaptive perfectionists during brief mindfulness meditation following stress-induction: A stratified-randomized trial. Int J Psychophysiol 2015 Oct;98(1):27-34. [CrossRef] [Medline]
  18. Wayne N, Ritvo P. Smartphone-enabled health coach intervention for people with diabetes from a modest socioeconomic strata community: single-arm longitudinal feasibility study. J Med Internet Res 2014 Jun;16(6):e149 [FREE Full text] [CrossRef] [Medline]
  19. Wayne N, Perez DF, Kaplan DM, Ritvo P. Health coaching reduces HbA1c in type 2 diabetic patients from a lower-socioeconomic status community: a randomized controlled trial. J Med Internet Res 2015 Oct 05;17(10):e224 [FREE Full text] [CrossRef] [Medline]
  20. Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: a qualitative inquiry. J Telemed Telecare 2016 Apr;22(3):172-178. [CrossRef] [Medline]
  21. Azam MA, Mongrain M, Vora K, Pirbaglou M, Azargive S, Changoor T, et al. Mindfulness as an alternative for university student mental health: cognitive-emotional and depressive self-criticism measures. Int J Educ Psychol 2016 Jun 24;2(3):140-163. [CrossRef]
  22. Bishop SR. Mindfulness: a proposed operational definition. Clin Psychol-Sci Pr 2004 Aug 01;11(3):230-241. [CrossRef]
  23. Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci 2008 Apr;12(4):163-169 [FREE Full text] [CrossRef] [Medline]
  24. Kabat-Zinn J. Mindfulness-based interventions in context: past, present, and future. Clin Psychol Sci Pract 2003;10(2):144-156. [CrossRef]
  25. Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry 1982 Apr;4(1):33-47. [CrossRef]
  26. Kabat-Zinn J. Full Catastrophe Living. New York, NY: Bantam; 1990.
  27. Segal ZV, Williams JM, Teasdale JD. Mindfulness-based cognitive therapy for depression. New York, NY: Guilford Press; 2012.
  28. Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med 2009 May;15(5):593-600. [CrossRef] [Medline]
  29. A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom 2015 Dec;84(1):30-36. [CrossRef] [Medline]
  30. Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol 2012 Oct;19(5):e343-e352 [FREE Full text] [CrossRef] [Medline]
  31. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a meta-analytic review. J Consult Clin Psychol 2010 Apr;78(2):169-183 [FREE Full text] [CrossRef] [Medline]
  32. Ritvo P, Vora K, Irvine J, Mongrain M, Azam MA, Azargive S, et al. Reductions in Negative Automatic Thoughts in Students Attending Mindfulness Tutorial Predicts Increase Life Satisfaction. Int J Educ Psychol 2013 Oct;2(3):272-296.
  33. Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther 2011;40(4):251-266. [CrossRef] [Medline]
  34. Boettcher J, Åström V, Påhlsson D, Schenström O, Andersson G, Carlbring P. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial. Behav Ther 2014 Mar;45(2):241-253. [CrossRef]
  35. Carlbring P, Hägglund M, Luthström A, Dahlin M, Kadowaki Å, Vernmark K, et al. Internet-based behavioral activation and acceptance-based treatment for depression: a randomized controlled trial. J Affect Disord 2013 Jun;148(2-3):331-337. [CrossRef] [Medline]
  36. Dahlin M, Andersson G, Magnusson K, Johansson T, Sjögren J, Håkansson A, et al. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: a randomized controlled trial. Behav Res Ther 2016 Feb;77:86-95. [CrossRef] [Medline]
  37. Gershkovich M, Herbert JD, Forman EM, Schumacher LM, Fischer LE. Internet-delivered acceptance-based cognitive-behavioral intervention for social anxiety disorder with and without therapist support: a randomized trial. Behav Modif 2017 Dec;41(5):583-608. [CrossRef] [Medline]
  38. Kivi M, Eriksson MC, Hange D, Petersson E, Vernmark K, Johansson B, et al. Internet-based therapy for mild to moderate depression in Swedish primary care: short term results from the PRIM-NET randomized controlled trial. Cogn Behav Ther 2014 Jun;43(4):289-298 [FREE Full text] [CrossRef] [Medline]
  39. Lappalainen P, Granlund A, Siltanen S, Ahonen S, Vitikainen M, Tolvanen A, et al. ACT internet-based vs face-to-face? A randomized controlled trial of two ways to deliver acceptance and commitment therapy for depressive symptoms: an 18-month follow-up. Behav Res Ther 2014 Oct;61:43-54. [CrossRef] [Medline]
  40. Lappalainen P, Langrial S, Oinas-Kukkonen H, Tolvanen A, Lappalainen R. Web-based acceptance and commitment therapy for depressive symptoms with minimal support: a randomized controlled trial. Behav Modif 2015 Nov;39(6):805-834. [CrossRef] [Medline]
  41. Ly KH, Trüschel A, Jarl L, Magnusson S, Windahl T, Johansson R, et al. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open 2014;4(1):805-834 [FREE Full text] [CrossRef] [Medline]
  42. Pots WT, Fledderus M, Meulenbeek PA, ten Klooster PM, Schreurs KM, Bohlmeijer ET. Acceptance and commitment therapy as a web-based intervention for depressive symptoms: randomised controlled trial. Br J Psychiatry 2016 Jan;208(1):69-77. [CrossRef] [Medline]
  43. Silfvernagel K, Carlbring P, Kabo J, Edström S, Eriksson J, Månson L, et al. Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial. J Med Internet Res 2012 Jun 26;14(3):e65 [FREE Full text] [CrossRef] [Medline]
  44. Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, et al. Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms: a meta-analysis of individual participant data. JAMA Psychiatry 2017 Apr 01;74(4):351-359. [CrossRef] [Medline]
  45. Mohr DC, Cuijpers P, Lehman K. Supportive accountability: a model for providing human support to enhance adherence to eHealth interventions. J Med Internet Res 2011 Mar;13(1):e30 [FREE Full text] [CrossRef] [Medline]
  46. Mackenzie CS, Reynolds K, Cairney J, Streiner DL, Sareen J. Disorder-specific mental health service use for mood and anxiety disorders: associations with age, sex, and psychiatric comorbidity. Depress Anxiety 2012 Mar;29(3):234-242 [FREE Full text] [CrossRef] [Medline]
  47. Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry 2010;10:113 [FREE Full text] [CrossRef] [Medline]
  48. Melville K, Casey L, Kavanagh D. Dropout from internet-based treatment for psychological disorders. Br J Clin Psychol 2010 Nov;49:455-471. [CrossRef]
  49. Wang PS, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Borges G, Bromet EJ, et al. Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. Lancet 2007 Sep;370(9590):841-850. [CrossRef]
  50. Smarr K, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken) 2011 Nov;63 Suppl 11:S454-S466 [FREE Full text] [CrossRef] [Medline]
  51. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59:22-33 [FREE Full text] [Medline]
  52. Andersson G. Using the internet to provide cognitive behaviour therapy. Behav Res Ther 2009 Mar;47(3):175-180. [CrossRef] [Medline]
  53. Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther 2009 Dec;38(4):196-205. [CrossRef] [Medline]
  54. Cavanagh K, Strauss C, Forder L, Jones F. Can mindfulness and acceptance be learnt by self-help?: a systematic review and meta-analysis of mindfulness and acceptance-based self-help interventions. Clin Psychol Rev 2014 Mar;34(2):118-129. [CrossRef] [Medline]
  55. Andersson G, Hesser H, Hummerdal D, Bergman-Nordgren L, Carlbring P. A 3.5-year follow-up of Internet-delivered cognitive behavior therapy for major depression. J Ment Health 2013 Apr;22(2):155-164. [CrossRef] [Medline]
  56. Julian L. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res 2011 Nov;63(Suppl 11):S467-S472 [FREE Full text] [CrossRef] [Medline]
  57. Reilly TJ, MacGillivray SA, Reid IC, Cameron IM. Psychometric properties of the 16-item Quick Inventory of Depressive Symptomatology: a systematic review and meta-analysis. J Psychiatr Res 2015 Jan;60:132-140. [CrossRef] [Medline]
  58. Worboys M. The Hamilton Rating Scale for Depression: the making of a "gold standard" and the unmaking of a chronic illness, 1960-1980. Chronic Illn 2013 Sep;9(3):202-219 [FREE Full text] [CrossRef] [Medline]
  59. Williams M, Dalgleish T, Karl A, Kuyken W. Examining the factor structures of the five facet mindfulness questionnaire and the self-compassion scale. Psychol Assess 2014 Jun;26(2):407-418. [CrossRef] [Medline]
  60. Lapane K, Quilliam BJ, Benson C, Chow W, Kim M. One, two, or three? Constructs of the brief pain inventory among patients with non-cancer pain in the outpatient setting. J Pain Symptom Manage 2014 Feb;47(2):325-333. [CrossRef] [Medline]


ANCOVA: analysis of covariance
BDI: Beck Depression Inventory
CAMH: Centre for Addiction and Mental Health
CBT: cognitive behavioral therapy
CBT-M: mindfulness-based cognitive behavioral therapy
CRF: case reporting form
DSM: Diagnostic and Statistical Manual of Mental Disorders
FN: First Nations
HDRS-24: 24-item Hamilton Depression Rating Scale
ITT: intention-to-treat
MINI: Mini-International Neuropsychiatric Interview
MM: mindfulness meditation
PP: per protocol
RCT: randomized controlled trial


Edited by G Eysenbach; submitted 26.07.18; peer-reviewed by A Martinez-Millana, A Yadollahpour, A Torbjørnsen, D Mohan, J Apolinário-Hagen; comments to author 07.10.18; revised version received 12.12.18; accepted 21.12.18; published 29.07.19

Copyright

©Paul Ritvo, Zafiris J Daskalakis, George Tomlinson, Arun Ravindran, Renee Linklater, Megan Kirk Chang, Yuliya Knyahnytska, Jonathan Lee, Nazanin Alavi, Shari Bai, Lillian Harber, Tania Jain, Joel Katz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.07.2019.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.