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Psychoeducation versus CBT
         for Bipolar Disorder:
           A CANMAT Study

      Sagar V. Parikh, Ari Zaretsky, Serge Beaulieu, Lakshmi N.
       Yatham, L. Trevor Young, Irene Patelis-Siotis, Glenda M.
        MacQueen, Anthony Levitt, Tamara Arenovich, Pablo
  Cervantes, Vytas Velyvis, Sidney H. Kennedy, and David L. Streiner.




Journal of Clinical Psychiatry, 2012 Jun;73(6):803-10.
                                                            www.canmat.org
About Bipolar Disorder

   BD is a serious lifetime condition
    – Elevated mood state (mania) + depression
   Prevalence of 1-3% worldwide
   High disability and mortality
   1st line of treatment: Complex pharmacotherapy
   Limitations of pharmacotherapy:
    – Relapses are common
    – Residual symptoms may persist

                                                 www.canmat.org
Psychosocial Interventions
   Complementary psychosocial interventions:
    –   Psychoeducation (PE)
    –   Cognitive-Behavioural Therapy (CBT)
    –   Family focused Therapy (FFT)
    –   Interpersonal /Social Rhythm Therapy (IP/SRT)

   Why psychosocial interventions?
    –   May modify stressors that could trigger episodes
    –   Enhance collaboration with treatment providers
    –   Can improve treatment compliance
    –   Could have direct biological treatment effects
    –   Help patients deal with psychological sequelae of illness


                                                          www.canmat.org
CBT

   Several models available, adapted from CBT for
    depression
   Individual sessions (≈ 20)
   Psychoeducation + cognitive and behavioral
    techniques
   Maintenance, relapse prevention,
   Studies to date: small to modest impact
    – underpowered?



                                          www.canmat.org
Psychoeducation

   Component of all psychosocial interventions for
    bipolar disorder
   Integrated or stand-alone treatment
   Symptom recognition, relapse management &
    prevention
   Group format
   Variable duration



                                            www.canmat.org
Hypothesis


A full course of CBT for bipolar
disorder will be more effective
    than psychoeducation.




                             www.canmat.org
Study Design
 A single-blind RCT
 18 month longitudinal assessment
 Patients with BD-I/BD-II
 4 academic research centers (Toronto, Hamilton, Montreal, Vancouver)
 Comparison of the relative effectiveness of…




                                vs.
         Brief Group PE                     Individual CBT
          (6 sessions)                       (20 sessions)
                                                        www.canmat.org
PE Intervention

 6 weekly ‘didactic’ sessions in group format, 90 minutes long
 Group size = 4-6 persons
 Covers topics such as illness recognition, treatment
  approaches, monitoring and coping strategies
 Based on manual by Bauer & McBride:
      The Life Goals Program - Phase I

 Delivered by experienced psychiatric staff
  (nurses, psychotherapists and psychiatrist)


                                                   www.canmat.org
CBT Intervention

   20 sessions of individual CBT, 50 minutes long
   Includes some basic psychoeducation
   Major emphasis on activity scheduling /
    behavioral activation
   Major emphasis on dysfunctional cognitions, both
    depressive and manic
   Based on manual by Lam et al.




                                                www.canmat.org
Outcome Assessment

 Primary outcome -- LIFE
  – Longitudinal Interval Follow-up Evaluation (LIFE)
  – Assesses the longitudinal course of depressive
    and manic symptoms for every week
  – Done for 72 weeks
  – Additional outcomes – time to relapse



                                           www.canmat.org
Participants
 Inclusion Criteria
   – BD-I or BD-II, age 18-64
   – Taking a mood stabilizer
   – ≥ 2 episodes of significant symptoms during the last
     3 years, excluding month preceding randomization
   – Could be in remission or have subsyndromal symptoms

 Exclusion Criteria
   – Episode of significant symptoms during the month preceding
     randomization
   – Current substance dependence, life-threatening medical illness
   – Antisocial or severe borderline personality disorder
   – Acute suicidality or homocidality
   – Significant cognitive deficits or language problems

                                                              www.canmat.org
Participants -- Flowchart
                                           537 Prescreened                 240 Patients Excluded


                                        297 Patients Screened              93 Patients Excluded
                                             for Eligibility         69 Did not meet inclusion criteria
                                                                     24 Refused to participate

                                           204 Randomized



      95 Patients Allocated to CBT                                 109 Patients Allocated to PE


63 “completers” (18-20 sessions)                             70 “completers” received 5-6 sessions
26 received partial intervention                             30 received partial intervention
6 received no sessions                                       9 received no sessions


63 completed all 18 months of assessment                     63 completed all 18 months of assessment
15 completed partial assessment                              19 completed partial assessment
17 did not provide any follow-up data                        27 did not provide any follow-up data


                                                                                      www.canmat.org
Participants – Key Features

 N = 204 randomized
 Bipolar I: 73%
 Mean age of first episode: 22.1 years
 Hospitalized for mood episode: 66%
 Lifetime number of episodes:
  – 13% had fewer than 5
  – 70% had more than 10
  – Depressive episodes far more frequent



                                            www.canmat.org
Sociodemographic Characteristics

Characteristic                             CBT           PE               p
Gender – % female                          63.2          53.2           0.15
Age at baseline – mean (SD)             40.9 (10.7)   40.9 (10.8)       0.96
Education – no. (%)
  Up to high school graduation          16 (16.8)     17 (15.6)
  Some university/university graduate   60 (63.2)     81 (74.3)         0.13
  Graduate studies                      16 (16.8)       9 (8.3)
  Unknown                                 3 (3.2)       2 (1.8)
Marital status – no. (%)
  Married or common law                 31 (32.6)     42 (38.5)
  Single                                37 (38.9)     44 (40.4)         0.44
  Divorced or separated or widowed      27 (28.4)     23 (21.1)

                                                                  www.canmat.org
Illness Characteristics
Baseline Characteristic                         CBT           PE                 p
Bipolar Subtype – no. (%)
  Type I                                      68 (71.6)    79 (72.5)         0.89
  Type II                                     27 (28.4)    30 (27.5)
Age of first mood episode – mean (SD)         22.2 (9.6)   22.0 (9.0)        0.88
> 10 episodes – no. (%)                       68 (71.6)    74 (67.9)         0.55
Hospitalization – no. (%)                     63 (66.3)    71 (65.1)         0.93
Anxiety Disorder (Lifetime) – no. (%)         49 (51.6)    48 (44.0)         0.28
Substance use disorder (Lifetime) – no. (%)   24 (25.3)    29 (26.6)         0.83
LIFE-Mania – mean (SD), across 4 weeks        1.3 (0.7)    1.3 (0.6)         0.96
LIFE-Depression – mean (SD), across 4 weeks   2.5 (1.4)    2.4 (1.2)         0.59
HAM – D – mean (SD)                           6.5 (4.8)    7.3 (5.0)         0.25
CARS-M – mean (SD)                            1.7 (2.6)    2.3 (3.5)         0.22

                                                                www.canmat.org
Results


Retention & compliance                Group PE      Individual CBT
Treatment completers (18-20 sess.)      64%          66%
Dropout rate prior to first session     8%           6%
Nb. sessions attended (M)               5            15


• Excellent medication compliance for both groups (ns)
• Use of mood stabilizers and atypical antipsychotics
  remained constant




                                                         www.canmat.org
Results: Symptoms
                           LIFE mean scores by treatment group – 8 week intervals
                                    Depression                                                             Mania
                                 Depression                                                               Mania
                 2.8                                                                 1.6


                 2.6
                                                                                     1.5


                 2.4
                                                                                     1.4
 Mean (+/- SE)




                                                                       Mean +/- SE
                 2.2
                                                                                     1.3
                 2.0

                                                                                     1.2
                 1.8

                                                                                     1.1
                 1.6


                 1.4                                                                 1.0
                       0    10   20    30          40   50   60   70                       0    10   20   30          40     50    60       70

                                            Week                                                               Week
                           PE                                                                  PE
                           CBT                                                                 CBT




• Significant decline in LIFE scores in both groups

• No significant difference by treatment group
                                                                                                                           www.canmat.org
Results: Time to Recurrence
Survival curves for recurrence with depressive or manic episode

   Major Depressive Episode               (Hypo)manic Episode
      N = 95 recurrences                   N = 59 recurrences




 • No difference in recurrence rate by treatment group


                                                         www.canmat.org
Results: Cost

 Psychoeducation                        CBT

2 staff hours/90 min. session     1 staff hour/session
         x 6 sessions           x 20 individual sessions
   @ 4 participants / group



  = $180 per participant        = $1200 per participant



                                              www.canmat.org
Discussion

 No differences in overall mood burden
    or rates of relapse
   Both treatments associated with significant
    decreases in overall mood burden
   Similar rates of completion/compliance

 CBT superiority hypothesis not confirmed



                                          www.canmat.org
Why?
 Poor fidelity to CBT? Unlikely!
   – Established research centres with experience in CBT
   – Random tape audit indicated good fidelity

 CBT is not superior? Likely!
   – No satisfactory theoretical model of CBT for BD
   – All psychosocial interventions for bipolar disorder address
     early symptom recognition and response
   – CBT for BD is currently a non-specific psychoeducational
     intervention with some cognitive & behavioural techniques
   – Not a specific, empirically driven approach based on a
     cognitive formulation


                                                      www.canmat.org
Limitations

   Participants recruited at academic medical centers
    – May not be representative of patients in the community

   No study control of medication use
    – But no differences between groups noted…

   No untreated control group
    – PE and CBT were equally ineffective?
       • Unlikely since improvement rates mirror those seen in earlier
         controlled trials…
    – Each treatment appears to have been (equally) effective

                                                            www.canmat.org
Psychoeducation or CBT
  in Bipolar Disorder?

Psychoeducation!
   …is less expensive
   …requires less clinician training
   …is as effective as CBT


                             www.canmat.org
Treatment                                     Hierarchy
                            VIII.
                      Psychodynamic/
                      Insight Therapy

                 VII. Occupational Therapy/
                        Rehabilitation

             VI. Detailed Family/Marital Therapy


        V. Brief Family/Marital Psychoeducation                   LIFE
                                                                  Goals
  IV. CBT or IPT if indicated After PE or For Depression


     III. Patient Psychoeducation (6 sessions)


  II. Tailored Health Services (Health Care Team)


  I. Pharmacotherapy and Clinical Management


      Bipolar Disorder Treatment Model (Parikh, 2002)
                                                           www.canmat.org
Psychoeducation versus CBT
        for Bipolar Disorder:
          A CANMAT Study

  Sagar V. Parikh, Ari Zaretsky, Serge Beaulieu, Lakshmi N. Yatham,
     L. Trevor Young, Irene Patelis-Siotis, Glenda M. MacQueen,
  Anthony Levitt, Tamara Arenovich, Pablo Cervantes, Vytas Velyvis,
              Sidney H. Kennedy, and David L. Streiner.




Journal of Clinical Psychiatry, 2012 Jun;73(6):803-10.
                                                          www.canmat.org

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Psychoeducation or Cognitive Behavioural Therapy for Bipolar Disorder

  • 1. Psychoeducation versus CBT for Bipolar Disorder: A CANMAT Study Sagar V. Parikh, Ari Zaretsky, Serge Beaulieu, Lakshmi N. Yatham, L. Trevor Young, Irene Patelis-Siotis, Glenda M. MacQueen, Anthony Levitt, Tamara Arenovich, Pablo Cervantes, Vytas Velyvis, Sidney H. Kennedy, and David L. Streiner. Journal of Clinical Psychiatry, 2012 Jun;73(6):803-10. www.canmat.org
  • 2. About Bipolar Disorder  BD is a serious lifetime condition – Elevated mood state (mania) + depression  Prevalence of 1-3% worldwide  High disability and mortality  1st line of treatment: Complex pharmacotherapy  Limitations of pharmacotherapy: – Relapses are common – Residual symptoms may persist www.canmat.org
  • 3. Psychosocial Interventions  Complementary psychosocial interventions: – Psychoeducation (PE) – Cognitive-Behavioural Therapy (CBT) – Family focused Therapy (FFT) – Interpersonal /Social Rhythm Therapy (IP/SRT)  Why psychosocial interventions? – May modify stressors that could trigger episodes – Enhance collaboration with treatment providers – Can improve treatment compliance – Could have direct biological treatment effects – Help patients deal with psychological sequelae of illness www.canmat.org
  • 4. CBT  Several models available, adapted from CBT for depression  Individual sessions (≈ 20)  Psychoeducation + cognitive and behavioral techniques  Maintenance, relapse prevention,  Studies to date: small to modest impact – underpowered? www.canmat.org
  • 5. Psychoeducation  Component of all psychosocial interventions for bipolar disorder  Integrated or stand-alone treatment  Symptom recognition, relapse management & prevention  Group format  Variable duration www.canmat.org
  • 6. Hypothesis A full course of CBT for bipolar disorder will be more effective than psychoeducation. www.canmat.org
  • 7. Study Design  A single-blind RCT  18 month longitudinal assessment  Patients with BD-I/BD-II  4 academic research centers (Toronto, Hamilton, Montreal, Vancouver)  Comparison of the relative effectiveness of… vs. Brief Group PE Individual CBT (6 sessions) (20 sessions) www.canmat.org
  • 8. PE Intervention  6 weekly ‘didactic’ sessions in group format, 90 minutes long  Group size = 4-6 persons  Covers topics such as illness recognition, treatment approaches, monitoring and coping strategies  Based on manual by Bauer & McBride: The Life Goals Program - Phase I  Delivered by experienced psychiatric staff (nurses, psychotherapists and psychiatrist) www.canmat.org
  • 9. CBT Intervention  20 sessions of individual CBT, 50 minutes long  Includes some basic psychoeducation  Major emphasis on activity scheduling / behavioral activation  Major emphasis on dysfunctional cognitions, both depressive and manic  Based on manual by Lam et al. www.canmat.org
  • 10. Outcome Assessment  Primary outcome -- LIFE – Longitudinal Interval Follow-up Evaluation (LIFE) – Assesses the longitudinal course of depressive and manic symptoms for every week – Done for 72 weeks – Additional outcomes – time to relapse www.canmat.org
  • 11. Participants  Inclusion Criteria – BD-I or BD-II, age 18-64 – Taking a mood stabilizer – ≥ 2 episodes of significant symptoms during the last 3 years, excluding month preceding randomization – Could be in remission or have subsyndromal symptoms  Exclusion Criteria – Episode of significant symptoms during the month preceding randomization – Current substance dependence, life-threatening medical illness – Antisocial or severe borderline personality disorder – Acute suicidality or homocidality – Significant cognitive deficits or language problems www.canmat.org
  • 12. Participants -- Flowchart 537 Prescreened 240 Patients Excluded 297 Patients Screened 93 Patients Excluded for Eligibility 69 Did not meet inclusion criteria 24 Refused to participate 204 Randomized 95 Patients Allocated to CBT 109 Patients Allocated to PE 63 “completers” (18-20 sessions) 70 “completers” received 5-6 sessions 26 received partial intervention 30 received partial intervention 6 received no sessions 9 received no sessions 63 completed all 18 months of assessment 63 completed all 18 months of assessment 15 completed partial assessment 19 completed partial assessment 17 did not provide any follow-up data 27 did not provide any follow-up data www.canmat.org
  • 13. Participants – Key Features  N = 204 randomized  Bipolar I: 73%  Mean age of first episode: 22.1 years  Hospitalized for mood episode: 66%  Lifetime number of episodes: – 13% had fewer than 5 – 70% had more than 10 – Depressive episodes far more frequent www.canmat.org
  • 14. Sociodemographic Characteristics Characteristic CBT PE p Gender – % female 63.2 53.2 0.15 Age at baseline – mean (SD) 40.9 (10.7) 40.9 (10.8) 0.96 Education – no. (%) Up to high school graduation 16 (16.8) 17 (15.6) Some university/university graduate 60 (63.2) 81 (74.3) 0.13 Graduate studies 16 (16.8) 9 (8.3) Unknown 3 (3.2) 2 (1.8) Marital status – no. (%) Married or common law 31 (32.6) 42 (38.5) Single 37 (38.9) 44 (40.4) 0.44 Divorced or separated or widowed 27 (28.4) 23 (21.1) www.canmat.org
  • 15. Illness Characteristics Baseline Characteristic CBT PE p Bipolar Subtype – no. (%) Type I 68 (71.6) 79 (72.5) 0.89 Type II 27 (28.4) 30 (27.5) Age of first mood episode – mean (SD) 22.2 (9.6) 22.0 (9.0) 0.88 > 10 episodes – no. (%) 68 (71.6) 74 (67.9) 0.55 Hospitalization – no. (%) 63 (66.3) 71 (65.1) 0.93 Anxiety Disorder (Lifetime) – no. (%) 49 (51.6) 48 (44.0) 0.28 Substance use disorder (Lifetime) – no. (%) 24 (25.3) 29 (26.6) 0.83 LIFE-Mania – mean (SD), across 4 weeks 1.3 (0.7) 1.3 (0.6) 0.96 LIFE-Depression – mean (SD), across 4 weeks 2.5 (1.4) 2.4 (1.2) 0.59 HAM – D – mean (SD) 6.5 (4.8) 7.3 (5.0) 0.25 CARS-M – mean (SD) 1.7 (2.6) 2.3 (3.5) 0.22 www.canmat.org
  • 16. Results Retention & compliance Group PE Individual CBT Treatment completers (18-20 sess.) 64% 66% Dropout rate prior to first session 8% 6% Nb. sessions attended (M) 5 15 • Excellent medication compliance for both groups (ns) • Use of mood stabilizers and atypical antipsychotics remained constant www.canmat.org
  • 17. Results: Symptoms LIFE mean scores by treatment group – 8 week intervals Depression Mania Depression Mania 2.8 1.6 2.6 1.5 2.4 1.4 Mean (+/- SE) Mean +/- SE 2.2 1.3 2.0 1.2 1.8 1.1 1.6 1.4 1.0 0 10 20 30 40 50 60 70 0 10 20 30 40 50 60 70 Week Week PE PE CBT CBT • Significant decline in LIFE scores in both groups • No significant difference by treatment group www.canmat.org
  • 18. Results: Time to Recurrence Survival curves for recurrence with depressive or manic episode Major Depressive Episode (Hypo)manic Episode N = 95 recurrences N = 59 recurrences • No difference in recurrence rate by treatment group www.canmat.org
  • 19. Results: Cost Psychoeducation CBT 2 staff hours/90 min. session 1 staff hour/session x 6 sessions x 20 individual sessions @ 4 participants / group = $180 per participant = $1200 per participant www.canmat.org
  • 20. Discussion  No differences in overall mood burden or rates of relapse  Both treatments associated with significant decreases in overall mood burden  Similar rates of completion/compliance CBT superiority hypothesis not confirmed www.canmat.org
  • 21. Why?  Poor fidelity to CBT? Unlikely! – Established research centres with experience in CBT – Random tape audit indicated good fidelity  CBT is not superior? Likely! – No satisfactory theoretical model of CBT for BD – All psychosocial interventions for bipolar disorder address early symptom recognition and response – CBT for BD is currently a non-specific psychoeducational intervention with some cognitive & behavioural techniques – Not a specific, empirically driven approach based on a cognitive formulation www.canmat.org
  • 22. Limitations  Participants recruited at academic medical centers – May not be representative of patients in the community  No study control of medication use – But no differences between groups noted…  No untreated control group – PE and CBT were equally ineffective? • Unlikely since improvement rates mirror those seen in earlier controlled trials… – Each treatment appears to have been (equally) effective www.canmat.org
  • 23. Psychoeducation or CBT in Bipolar Disorder? Psychoeducation! …is less expensive …requires less clinician training …is as effective as CBT www.canmat.org
  • 24. Treatment Hierarchy VIII. Psychodynamic/ Insight Therapy VII. Occupational Therapy/ Rehabilitation VI. Detailed Family/Marital Therapy V. Brief Family/Marital Psychoeducation LIFE Goals IV. CBT or IPT if indicated After PE or For Depression III. Patient Psychoeducation (6 sessions) II. Tailored Health Services (Health Care Team) I. Pharmacotherapy and Clinical Management Bipolar Disorder Treatment Model (Parikh, 2002) www.canmat.org
  • 25. Psychoeducation versus CBT for Bipolar Disorder: A CANMAT Study Sagar V. Parikh, Ari Zaretsky, Serge Beaulieu, Lakshmi N. Yatham, L. Trevor Young, Irene Patelis-Siotis, Glenda M. MacQueen, Anthony Levitt, Tamara Arenovich, Pablo Cervantes, Vytas Velyvis, Sidney H. Kennedy, and David L. Streiner. Journal of Clinical Psychiatry, 2012 Jun;73(6):803-10. www.canmat.org