Instituto Nacional de Psiquiatría (México) XXIV Reunión Anual de Investigación 6 de octubre del 2009 Intervención por Internet para la depresión. Efectos del programa y obstáculos para su difusión Presenta: Dr. Gregory N. Clarke

1. Internet CBT for DepressionModest Effects, Population-Level Potential, Solutions to Dissemination Barriers Greg Clarke PhD Kaiser Permanente Center for Health Research (CHR) Portland Oregon

2. My Recent Research Activities, Interests Youth depression CBT, pharmacotherapy Targeted prevention of youth depression Insomnia CBT for adolescents Dissemination of mental health evidence-based treatments (EBTs) Internet CBT for adult depression Focus of today’s talk

3. Overview of Talk Gaps in depression care Low availability (Reach), poor quality (Implementation) Low intensity interventions as part of solution Bibliotherapy interventions generally Internet-delivered CBT in particular Review of literature, our specific randomized trials Implementation models, issues Stepped care, population level dissemination

4. Gaps in Depression Care:Quality Improvement is Needed! High prevalence, 2-3x risk in females Significant psychiatric and social morbidity Greatly increased risk of completed suicide Poor quality of life, increased cost to society Several strong evidence-based treatments (EBTs): Antidepressants, CBT, IPT, etc. And yet -- poor quality of care in community

5. Traditional Depression Treatments: Poor Reach (lack of availability) Depression EBTs are often not available to persons needing them in the community Stigma, poor follow-though with referrals Structural or systemic barriers (e.g., few mental health specialists co-located with primary care services) Higher costs of specialty MH care Insufficient capacity to deliver high quality care

6. Feasibility of DisseminatingTraditional Psychotherapy Can’t we address low accessibility by promoting wider dissemination of traditional treatments? US trends in recent decades: Declining psychotherapy rates But higher antidepressant rates Unlikely to see ‘public health’ dissemination of traditional, face-to-face psychotherapies Might be easier in Mexico, with its universal healthcare & centralized public health

7. Traditional Depression Treatments: Poor Implementation Even when evidence-based treatments (EBTs) are available they are often poorly delivered (low Implementation or Adherence) Low provider adherence to quality guidelines Due to limited time, training gaps, reimbursement limits Low patient adherence to dosing or behavioral instructions Due to side effects, costs, ambivalence, stigma

8. Barriers to Increasing Reach, Implementation of Traditional Treatments Pharmacotherapy Adverse side effects Patient ambivalence Premature discontinuation, poor adherence Small effect above placebo? With generic SSRIs, cost is not so much of a problem Face-to-Face Psychotherapy Cost, reimbursement limits Few trained in EBT therapies Few MH specialists in some settings (e.g., rural areas) Discomfort with disclosure Stigma

9. Low Intensity Treatments: a Partial Solution to Dissemination Problems? Low intensity treatments may have a role to play in addressing the gap in depression care Several variants, with or without supportive therapist contacts: Bibliotherapy – books, pamphlets DVDs, video Computerized interventions (most often CBT) Internet-delivered interventions (most often CBT)

10. Different Types of Low Intensity Therapy Pure Internet CBT (aka self-administered therapy) Bibliotherapy, video, Internet site with no or very little direct contact with live therapist or coach Guided Internet CBT (aka minimal contact therapy) Instructional materials + modest contact with live therapist or coach, often by telephone or email rather than in-person Typically 2 to 4 cumulative hours of therapist contact vs. 12 to 26 hrs contact in traditional EBT psychotherapies

14. MoodHelper: 4 Content Modules Improve Your Mood Tutorials in behavioral or cognitive therapy We consider this the “curative” element Depression Facts Measure Your Mood Journals Private “blog” which could be selectively published for viewing by others

15. Customization: 1of 3 pages of preference questions

16. Customization: Pts add or remove activities from ranked list

17. Customization: These boxes allow Pts to personalize goals, rewards

18. This Contract summarizes all the choices made by the Pts on the previous pages

19. Interactivity: Pts are asked to return and record mood and activities for each day

20. Daily mood and activity data is graphed to see patterns Narrative feedback provided is on subsequent pages (“You never report doing two fun activities. We suggest dropping these and adding 2 more.”)

22. Low-Intensity Treatments may Improve Reach Low Intensity EBTs (particularly Internet, books) can be used at home, are anonymous, are available 24/7 More individuals potentially served, at a lower cost May be best—or only—option for rural areas, or anywhere MH specialists are in short supply Are some patients who decline traditional treatments those who would prefer low-intensity CBT as 1st step? More comfortable with anonymity, no face-to-face disclosure? “Gateway” experience to prepare for traditional therapy?

23. Is Internet Access Good Enough? Source: Pew Internet & American Life Project, August 2008, except * December 2008

24. Spanish Internet CBT Site – Coming Soon We are currently translating the Internet CBT program into Spanish: AnimoOnline.org Bilingual, bicultural telephone coaches Translation led by Nangel Lindberg PhD Researcher, co-investigator at our Center Trained in clinical psychology at UCLA Native of Mexico Distrito Federal (Mexico City) Many years experience translating from English to Spanish Website will be tested in future randomized trial

25. Do Bibliotherapy EBTs ‘Compete’ with Traditional Treatments? Internet interventions are not meant to replace or directly compete with traditional treatments Despite this, some trials have found that Internet CBT may yield effects equal to traditional Tx’s Our view: these alternatives occupy different niches in the progression of treatment intensity See stepped care models later

26. Is CBT the only Viable Approach for Internet Interventions? Most, or perhaps all, Internet mental health interventions are based on CBT Other approaches should work equally well if: They can be delivered in a psycho-educational format If they have a set of guidelines and skills to train Examples – not an exhaustive list: Acceptance and Commitment Therapy (ACT) Dialectical Behavior Therapy (DBT) Motivational Enhancement Therapy (MET)

27. Diminished Therapeutic Relationship vs Anonymity Traditional psychotherapists dismiss Internet therapy due to the lack of face-to-face contact: Reduces ability to read nonverbal cues May diminish or eliminate therapeutic relationship However, Pts who choose to forego traditional treatments because of stigma or discomfort with disclosure may appreciate the anonymity of Internet therapy, even with telephone contacts

28. Summary of Best ‘Fit’ for Internet EBTs Monotherapy for persons with less severe disorder As augmentation to traditional treatments (combo Tx) The early stages of a stepped care protocol “Bridging” care while waiting for traditional treatment? For persons not ready for—or uncomfortable with—traditional face-to-face therapy A low risk, low demand way to test the waters? Where mental health specialists are in short supply For population-scale dissemination

29. Research on Internet CBT

30. Effects of Internet CBT Meta-analyses of Internet CBT Effect Size (ES) d = 0.27 to 0.50 range Larger effects when compared to waitlist Smaller effects when compared to active control conditions Our 2005 and 2009 trials ES’s of d = .28 and .20, respectively, in the full samples Compared to a “strong” control condition called treatment as usual (TAU), consisting mainly of antidepressants +/or face-to-face psychosocial (therapy) visits

31. Relative Effects of Pure vs Guided Internet Therapy Only one study has directly compared Pure versus Guided Internet CBT (for social phobia) A large effect (ES of ~ d = 1.00) for Guided Bibliotherapy A small-medium ES of d =.38 for Pure Bibliotherapy Meta-analyses find similar results across studies Guided Bibliotherapy seems to be more clinically potent than Pure Bibliotherapy However, it is more costly than Pure Bibliotherapy

32. Direct Costs: Traditional Psychotherapy vs. Guided vs. Pure Bibliotherapy CBT Costs per individual Pt. Staff salary, fringe, overhead figured @ $70/hr. *few studies so far, most targeting anxiety

33. Indirect Cost Advantagesof Internet Interventions Patient Cost-Time Advantages: Less time spent traveling to clinics, waiting, medical visits, and participating in intervention Fewer lost work hours <Pt cost of Internet access is a disadvantage> Societal, Organizational Cost Advantages: Reduced need for office space, facility costs, infrastructure More widespread depression treatment = reduced unemployment, retained human capital, more tax revenue? Lower rates of depression in offspring?

34. Our Two Internet CBT Programs ODIN Overcoming Depression on the InterNet Cognitive restructuring (CR) only Pure self help – older, “retired” version Two published RCTs; 2002 and 2005 MoodHelper.org Updated security, software platform added behavioral Tx Pure self help (Guided version piloted in case series) Small (n=160) RCT (2009)

35. Two ODIN Trials Older, less sophisticated website (c. 1999) Two RCTs of similar design (N’s = 301, 259): Access to website vs. no access TAU control condition in both studies 2nd trial added either telephone or postcard reminders to return and use the CBT site Enrolled self-identified “depressed” adults (Mean score on baseline CES-D =~ 30)

36. ODIN1 and ODIN2 Results No overall benefit for 2002 ODIN11 trial Interpreted as due to low dose, particularly return use Modest effect for 2005 ODIN2 trial 2 with reminders to return and use treatment: Small effect size (ES) = .28 sd in entire sample Moderate ES = .55 sd in severely depressed subjects At 32 week follow-up 20% fewer ODIN S’s were in the moderately depressed range (56%) compared to TAU (76%) 1 Clarke et al (2002). J Med Internet Res,4(3), e14 www.jmir.org/2002/3/e14/ 2Clarke et al. (2005). J Med Internet Res,7(2), e16 www.jmir.org/2005/2/e16/

37. Control F(1,523)=4.93, P=.03, ES sd = .28 Treatment

38. Updated: MoodHelper.org ODIN was created in 1999 Obsolete programming, security ODIN employed cognitive restructuring only MoodHelper was developed in 2005: Added behavioral therapy Improved interactivity, customization, security

39. MoodHelper Pilot RCT HMO members with depression Dx, services Mean age 22.6 yrs (range 18-24), 81% female, 82% white 160 enrolled, randomized to: Treatment-as-usual (TAU) control condition TAU + MoodHelper + postcard reminders Patient Health Questionnaire (PHQ-8) at baseline (week 0), and 5, 10, 16, and 32 weeks follow-up

40. PHQ-8 Outcomes: Total Sample t=-1.97, error df=442, p = .05 Overall ES d = .20

41. PHQ-8 Outcomes: Female only t=-1.96, df=363,p=0.05 Female only ES d = .42

42. MoodHelper Pilot Summary ~ 20% never used MoodHelper beyond initial session, despite reminders Effects observed even in context of TAU control However, effects modest at best (d=.20 to .42) Reminder: traditional CBT produces an ES of .25 -.35 when compared to other treatments* Combination of traditional CBT + Rx has only modest advantage of ES d = .35 over monotherapy Rx alone** *Gloaguen et al. J Affective Disorders. 1998;49, 59-72. **Cuijpers et al. Depress Anxiety. 2009;26(3):279-88.

43. Can Small Effects Still be Clinically Significant? ES d = ~.25 for Pure Self-Help, ~.40 for subgroups, ~ 1.00 for Guided Self-Help Are small, medium effects clinically relevant? For subthreshold Pts, prevent progression into full syndrome? Small average effects still may include some persons with individually medium to large effects Small effects may still be useful when (a) delivered at public health scale, and (b) for low cost The “new norm” in era of incremental improvements on TAU, combination treatments (CBT augment to Rx yields d = .35)

44. Internet Research Challenges Enrollment: often < 5% of approached persons Retention: high dropout, with some studies reporting retention < 10% (we average ~ 75%-85%) High Initial Development Costs Frequent Updating Costs: security, new features, social networking, Twitter, etc. Limited Assessment: usually brief self-report

45. Curative Features of Internet Programs Interactivity: Pt enters scores, data, and information is returned Pt is sent automated text messages, email reminders Personalization, Customization: Feedback is customized to fit the individual’s data Example: providing different skills depending on stage of change Extensive Media, Video

46. Internet Interventions: A Role in Stepped Care? Well-suited to the initial, low-intensity stages of stepped care models Treatments generally arranged from least intensive to progressively more costly and intensive Several variants possible: Progressing from self-help to more traditional treatments Increasing intensity of services just within self-help variants