A Randomized Controlled Trial of In-Person and Telephone Cognitive Behavioral Therapy for Major Depression after Traumatic Brain Injury

Transcription

1 A Randomized Controlled Trial of In-Person and Telephone Cognitive Behavioral Therapy for Major Depression after Traumatic Brain Injury Josh Dyer, PhD Department of Rehabilitation Medicine University of Washington

2 University of Washington Jesse Fann, MD, MPH (PI) Charles Bombardier, PhD (Co-PI) Sureyya Dikmen, PhD Jennifer Zumsteg, MD Kenneth Marshall, MSW Josh Dyer, PhD Nancy Temkin, PhD Steven Vannoy, PhD Kathleen Bell, MD Jason Barber, MS Group Health Research Institute Evette Ludman, PhD Greg Simon, MD, MPH

3 Overview Background LIFT Study Results Preliminary Conclusions......

4 Background Pieces of Me from

5 Depression Post-TBI Poor social functioning 50% MDE in First Year* Poor ADLs Unemployment More somatic complaints More postconcussive symptoms *Bombardier, Fann, Temkin, JAMA 2010

6 Barriers to Treatment 1/3 of those with depression receive any mental health treatment Of these, 25% attend 1 session and 52% receive minimally adequate treatment * With TBI add barriers of limited transportation, inability to drive, other motivational (lack of initiative), cognitive, social and financial problems Wang et al, Arch Gen Psych, 2005

7 Table 2. Subjects Likely To Participate In Treatment Treatment Modality Depressed n=37 Non-Depressed N=108 Total Sample N=145 Physical Exercise 33 (89.2%) a 88 (82.2%) c 121 (84.0%) c Counseling/Psychotherapy 29 (78.4%) a 69 (63.9%) a,b 98 (67.6%) b Antidepressants 27 (73.0%) 42 (38.9%) 69 (47.6%) Alternative or Herbal 25 (67.6%) 66 (61.1%) b 91 (62.8%) a Self-Help Materials 23 (62.2%) 68 (63.0%) a,b 91 (62.8%) a Group Therapy 16 (43.2%) 47 (43.5%) 63 (43.4%) Note: Differences reported are among treatment modalities within each column. a: Favored over Group Therapy b: Favored over Antidepressants c: Favored over all modalities Fann et al, JHTR 2009

8 Psychotherapy/Rehab Trials in TBI 8 studies One class I study (Powell et al., 2002), N=110 comprehensive, community based, interdisciplinary team intervention targeted to multiple outcomes. demonstrated improvements in general psychological well-being, but not depressive symptoms specifically None specifically targeted depressed patients Difficult to identify active ingredients Cognitive behavioral approaches showed the most promise Problem-solving approaches may also be helpful Fann, Hart, Schomer, J Neurotrauma 2009

9 CBT and Phone Therapy CBT may be effective for persons with TBI and: Post-concussive Symptoms (Sayegh et al, 2010) CBT is effective when administered over Phone Reduction in depressive symptoms compared with controls (d=.26) Mean attrition rate = 7.6% (Mohr et al, 2008) Lower attrition than in person CBT (Mohr et al, 2012) Telephone Follow-up after TBI improves: PCS, functional status & QOL (Bell et al, 2005, 2008) Depressive symptoms (Bombardier et al, 2009) Phone CBT superior to Phone Care Management 8 sessions in Primary Care (Simon, Ludman, et al, JAMA 2004)

10 Modifiable Depression Risk Factors

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12 Life Improvement Following TBI Funding: NIH & NIDRR (DOE) Timeline: 5 Years ( ) Site: University of Washington Recruitment: National Design: 3-arm RCT Randomization: Choice-stratified Intervention: 12-session CBT w/ TBI Care Mgmt Compensation: up to $100 Enrolled: N=100

13 Inclusion Criteria At least 18 years old English speaking Lives in the United States Meet DSM-IV criteria for Major Depression Complicated mild to severe TBI TBI in the past 10 years Note: All criteria confirmed via phone

14 Exclusion Criteria No phone No stable home Severe mental illness bipolar disorder or schizophrenia or current psychosis or suicidal intent Current (within 1 month) alcohol or other drug dependence Significant cognitive impairment scores below thresholds in 2 of 4 cognitive tests Currently in or plan to start evidence-based psychotherapy treatment for depression Started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within 16 weeks

15 Eligibility and Randomization Phone CBT In-Person CBT Usual Care 2 2 mo mo 12 Weeks of modified CBT w/ TBI Care Management 2 mo 4 mo 4 mo 4 mo 6 mo 6 mo 6 mo

16 Choice-Stratified Randomization Option #1 Option #2 Option #3 Phone CBT In-Person CBT Usual Care Participants chose:

17 Intervention 12 Weekly sessions minutes (flexible) Manualized Weekly homework

18 Session 1

19 Sessions 2-6

20 Sessions 7-10

21 Sessions 11-12

22 Reason Slowed information processing & responding Impaired attention & concentration Impaired learning & recall Accommodations Present information at slower rate Allow client more time to respond Provide written summary of session beforehand Minimize distractions Use shorter sessions Avoid multi-tasking (e.g. no note taking while listening) Provide Patient Workbook Written homework Outlines/Summaries Plan additional practice of CBT skills within session (over-learn skills)

23 Reason Impaired verbal abilities Impaired initiation & generalization Impaired motivation Accommodations Emphasize behavioral activation and pleasant events scheduling Minimize emphasis on verbally mediated aspects of CBT Include family or friend Provide 2 sessions devoted to generalization and relapse prevention at end Use motivational interviewing techniques Provide care management activities aimed at return to work, school. Or other meaningful roles and finding effective rehabilitation resources

24 Other Unique Features..Concurrent treatments OK..Flexible scheduling..flexible protocol.. Usual Care is non-restrictive

25 Outcomes to be Assessed Depression Mediators Functioning & QOL HAM-D EROS SDS SCL-20 IPAQ SF-36 PHQ-9 SCID ATQ DAS WAI Satisfaction with treatment survey

26 Results

27 Demographics Age (SD) 45.7 (13.3) Sex 63% Male Race 90% Caucasian 3% 2+ Races 2% each Hispanic, NA/Alaska, Asian 1% Black Education 52% some college or vocational school 26% high school or equivalent 22% completed college TBI severity (GCS) 69% complicated mild/moderate 31% severe Years since injury (SD) 3.23 (2.69) Marital Status 45% divorced/separated/widowed 30% single/never married 25% married/civil union Mechanism of Injury 38% MVA 34% fall 8% each - pedestrian, assault 6% falling object 5% bike accident 1% recreation/sports

28 Baseline Neuropsychological Functioning Mean SD Digit Span HVLT-R* Oral Trails A (sec)* Oral Trails B (sec)* *below 5 th percentile

29 Baseline Depression Assessments N=100 Mean SD PHQ HAM-D SCL No. of Prior Depressive Episodes (SCID) N= % 13% 31% 44%

30 Baseline Mental Health 18% 10% 4%

31 Baseline Mental Health Assessments Yes Hx of PTSD 18% Current Alcohol Abuse (MINI) 10% Current Substance Abuse (MINI) 4%

32 Participation / Attrition Sessions Phone CBT In-person CBT Total < (8%) (22%) (14%) (55%) Total Mean # of sessions completed = 7.1 (4.1) No difference between In-person vs Phone

33 PHQ-9 Score Average PHQ-9 Score Per Session Telephone In person Session

34 Reduction 50% Remission <5 Baseline Final Change Phone CBT n=34 In-person CBT n=15 Total n=49 18 (53%) 8 (53%) 26 (53%) 10 (29%) 3 (20%) 13 (27%) (49%) 6.8 (52%) 8.2 (50%)

35 Preliminary Conclusions In-person and Telephone CBT for depression appears feasible in persons with complicated mild to severe TBI Telephone CBT can overcome barriers to care (e.g., remote Alaska participant, transportation) Telephone CBT appears equally effective as inperson CBT In-person or phone CBT is acceptable to most participants, with a greater preference for phone CBT Choice-stratified randomization likely increases ecological validity in multi-arm TBI depression studies

36 Dissemination

37 Thank you! Josh Dyer, PhD