1. Cognitive behavioural therapy and return to work intervention for primary care patients on sick leave due to common mental disorders - A randomized clinical trial 1 Sigrid Salomonsson, psychologist, PhD student Gustavsberg Primary care, Stockholm, Sweden Karolinska Institutet

2. BACKGROUND

3. Common mental disorders (CMD) in primary care Highly prevalent 30-50% of patients in primary care have psychiatric problems (Ansseau, 2004; Norton, 2007; Roca, 2009) Anxiety and depression: 17% point prevalence (Johansson et al., 2013) Strong evidence for cognitive behavioral therapy (CBT) Anxiety disorders Depression Insomnia Lack of availability to evidence-based treatments

4. Lack of evidence regarding adjustment disorder and exhaustion disorder Adjustment disorder - DSM, secondary diagnosis, - Criticized criteria, lack of evidence regarding prevalence and treatment - Most prevalent diagnosis among patients on sick leave in many countries Exhaustion disorder - Swedish ICD-diagnosis - Criticized criteria, lack of evidence regarding prevalence and treatment - Most prevalent diagnosis among patients on sick leave in Sweden

5. Adjustment disorder  The development of emotional or behavioral symptoms in response to an identifiable stressor(s) occurring within 3 months of the onset of the stressor(s).  These symptoms or behaviors are clinically significant as evidenced by either of the following: (1) marked distress that is in excess of what would be expected from exposure to the stressor (2) significant impairment in social or occupational (academic) functioning  The stress-related disturbance does not meet the criteria for another specific Axis I disorder and is not merely an exacerbation of a preexisting Axis I or Axis II disorder.  The symptoms do not represent Bereavement.  Once the stressor (or its consequences) has terminated, the symptoms do not persist for more than an additional 6 months.

6. Exhaustion disorder  Physical and psychological symptoms of fatigue for at least two weeks, developed as a result of identifiable stress factors, which have persisted for at least six months.  A substantial lack of psychic energy, as showed in reduced initiative, decreased stamina, and prolonged recovery in response to psychological stress.  Four of the following symptoms have persisted daily during the two week period: Difficulty concentrating or memory impairment; Significantly decreased ability to manage duties or to do things under pressure; Emotional lability and irritability; Sleep disturbance, Substantial bodily weakness or tiredness, Physical symptoms such as aches, chest pain, palpitations, gastrointestinal symptoms, dizziness and sensitivity to sound.  Symptoms cause clinically significant distress or impairment in social, occupational or other important areas.

7. CMD; costs and sick leave Produce most long-term sick leaves of all medical conditions ( Henderson, et al 2011 ) Henderson, et al 2011 The costs of mental disorders are comparable to those of physical illnesses. (CMD 75 % of all mental disorders) ( Smit, F. 2006 ) Greatest costs are work related ( OECD ) OECD

8. Aims Evaluate a new return to work (RTW) intervention - as stand alone treatment - in combination with evidence-based CBT - compared to evidence-based CBT for primary care patients on sick leave due to CMD

9. METHODS

10. FU 6 month FU 6 month FU 12 month FU 12 month Post Treatment Post Treatment Baseline Start Baseline Start CBT RTW Assessment 211 patients RTW CBT RTW=Return to work

11. Inclusion and setting 4 primary care clinics in Stockholm Adults, 18-65 years Sick listed 1-6 months (50-100%) due to; A principal diagnosis of: Depression, Adjustment disorder, Exhaustion disorder, Social anxiety disorder, Panic disorder, Generalized anxiety disorder, Obsessive- compulsive disorder, PTSD, Insomnia

12. Participant demographics and principal disorder N=211 Mean age: 42 82% women 60 % comorbid diaorders

14. Treatments CBT Individual, specific protocols for each diagnosis, gold standard NICE Guidelines such as Clark’s and Well’s treatment of social phobia RTW 7-11 sessions CBT principals Focus on attaining a sustainable work situation Psychoeducation Creating a plan to return to work based on patient’s goals Meeting workplace, doctor and assurance agency CBT+RTW Full treatments Starting with RTW focus, runs throughout treatment After initial 3 RTW sessions CBT starts

15. Meausurements and data completion Sick leave Days on sick leave from registry Data completion rate 100 % 1 year after randomization

16. Meausurements and data completion Clinician rated psychiatric symptoms Clinician severity rating (CSR) 198 patients (94 %) completed the interview post treatment

17. RESULTS

18. Reduction of sick leave measured quarterly

19. Quarterly reduction of sick leave, patients with depression, anxiety and insomnia

20. Quarterly reduction of sick leave, patients with adjustment- or exhaustion disorder

21. Total days on sick leave, 12 months after randomization, all patients No significant differences CBT147 days RTW124 days CBT+RTW:133 days (p=.10-.51)

22. Total days on sick leave, 12 months after randomization, patients with anxiety, depression or insomnia No significant differences CBT190 days RTW100 days CBT+RTW:107 days (p=.01,.02,.56)

23. Total days on sick leave, 12 months after randomization, patients with adjustment or exhaustion disorder No significant differences CBT137 days RTW132 days CBT+RTW:148 days (p=.26-.59)

24. Clinician severity rating (CSR) Cut off for diagnosis Before After CBT RTW CBT+RTW Effect size Within group d=1.6-2.5*** Between group CBT vs RTW: d=0.4* (CI= 0.1-0.8) CBT vs CBT+RTW: d=0.2 (CI= -0.1-0.6) RTW vs CBT+RTW: d=0.2 (CI= -0.1-0.5)

25. Conclusions RTW and RTW+CBT - Faster reduction of sick leave than CBT - No difference in days on sick leave after 12 months - Large differences for patients with depression, anxiety and insomnia, 75-92 days Large effect sizes for treating CMD with CBT in primary care - CBT was significantly more effective than RTW - No other significant differences between groups - CBT for adjustment and exhaustion disorder as effective as for depression, anxiety and insomnia

26. Strengths and Limitations +RCT design +Fairly well powered study +Good generalizability; consecutive recruitment, all of the most prevalent disorders +Valid, reliable measurements +Thorough assessment +Low attrition -Large group with exhaustion disorder and adjustment disorder -Absence of untreated control group, unknown effect compared to no treatment -Low power for diagnosis-specific analysis

27. THANK YOU

28. STUDY II

29. Stepped care treatment with cognitive behavioral therapy for common mental disorders in primary care – a randomized controlled trial 29

30. Aims Evaluate the effectiveness of a stepped care model for CMD in primary care 1.Evaluate the effectiveness of guided self-help CBT for CMD in primary care 2.Investigate if face-to-face CBT could enhance improvement for patients not in remission after guided self-help CBT

31. METHODS

32. Design Phase 1 N=396 Common mental disorders Guided self-help CBT Phase 2 Face-to-face CBT Guided self- help CBT In remission, no more treatment Randomization

33. Trial setting and inclusion 4 primary care clinics in Stockholm Adults Diagnosis or subthreshold problems: Depression, Adjustment disorder, Exhaustion disorder, Social anxiety disorder, Panic disorder, Generalized anxiety disorder, Obsessive-compulsive disorder, Insomia

34. Assessment MINI diagnostic interview Diagnosis or subthreshold severity (CSR/clinician severity rating: 2-6)

35. Participant demographics and principal problem area N=396 Mean age: 37 Women: 72% Severity level: 89% diagnosis 11% subthreshhold

36. Treatments Guided self-help CBT: Diagnosis-specific self-help book Motivate patients to the same changes as in face-to- face CBT Phase 1: two sessions with licensed psychologist Phase 2: one session with licensed psychologist

37. Treatments Face-to-face CBT: Phase 2 only Diagnosis-specific treatments According to gold standard Delivered by licensed psychologist Up to 15 sessions

38. Meausurements and data completeness Baseline, after phase 1 ( at 9 weeks ), after phase 2 ( at 20 weeks ) Self-rating, diagnosis specific scale Cut-off for definition of “in remission” Closer to normal population or 2 SDs from clinical population Data completeness 347 patients (88 %) provided data at 9 weeks 322 patients (81%) provided data at 20 weeks

39. RESULTS

40. Design Phase 1 Phase 2 N=396 Common mental disorders Guided self-help CBT Face-to-face CBT Guided self- help CBT In remission, no more treatment Randomization

41. Results: phase 1 (all patients) Phase 1 N=396 Common mental disorders Guided self-help CBT In remission, no more treatment Randomization 48% 52%

42. Results: phase 2 After phase 1 of guided self-help; 167 (48%) patients of 347 patients measured were not in remission according to self-rating 143 patients randomized and meausured: Face-to-face CBT: 70 patients Continued guided self-help: 73 patients Face-to-face CBT Guided self- help CBT Randomization Phase 2

43. Results: phase 2 (randomized patients)

44. Conclusions A stepped care treatment program could be a viable solution to increase accessibility to evidence-based psychological treatment for the large group of primary care patients with common mental disorders 1.Guided self-help CBT seems to be effective for primary care patients with common mental disorders 2.For patients not in remission, intensified CBT (face-to-face) seems to give additional improvement

45. Strengths and Limitations +RCT design +Well powered study +Good generalizability; consecutive recruitment, all of the most prevalent disorders +Valid, reliable measurements +Thorough assessment +Fairly low attrition -No control group in phase 1 -Difficult to assess patient adherence to self-help CBT -Low power for diagnosis-specific analysis

46. FURTHER STUDIES

47. Predictors and moderators  Outcome determinants in psychological treatment of common mental disorders; - predictors of positive outcome on RTW - predictors of positive outcome on guided selfhelp - psychological and biological moderators of change for patients with exhaustion disorder and social phobia  100 patients with adjustment- or exhaustion disorder randomized to I-CBT or waitlist control

48. Aims To investigate predictors and moderators of symptom outcome and sick leave in cognitive behavioral therapy for primary care patients with common mental disorders

49. METHODS

50. Study samples Participants from Study I (N=211) Participants from Study II (N=396)

51. Types of predictor/moderator variables Demographic; gender, age Clinical; level of depression, comorbidity Therapy related; expectancy of treatment outcome, treatment adherence

52. Types of outcomes Symptoms: continuous scale improvement Regression analysis using residual gain score Symptoms: clinically significant improvement Logistic regression, investigate predictors of outcome among patients with equal baseline symptoms, who recovers after treatment? Sick leave Assessment occasions Post-treatment and 1-year follow-up

53. Relevance Findings may be useful for the clinician when making treatment recommendations Additional services may be considered for patients at high risk of non-response Potential to identify patients suitable for self-help treatment and face-to-face treatment, respectively Improve overall recovery rates

54. In summary CBT is effective in treating common mental disorders in primary care Sick leave is faster reduced with the RTW intervention CBT can successfully be delivered in a cost effective stepped care model with guided self-help CBT Knowledge about predictors and moderators may improve treatment recommendations and reduce drop-out

55. Thank you! Research group: Erik Hedman, Associate professor Brjánn Ljótsson, Associate professor Lars-Göran Öst, Professor Mats Lekander, Professor Kersti Ejeby, PhD-student Martin Ingvar, Professor Fredrik Santoft, PhD-student Elin Lindsäter, PhD-student GPs and therapists at the primary care clinics!