Group Delivered Exposure, Cognitive, and Skills Therapies in Female OEF/OIF Veterans: Data and DetailsDiane T. Castillo, Ph.D.Treatment Core ChiefCenter of Excellence for Research on Returning War VeteransAssociate Professor, Texas A&M, College of Medicine

AMSUS December 2, 2015

Award Number(s):  W81XWH-08-2-0022Funding Agency: DoD CDMRP

Disclosureso The presenter has no financial relationships to disclose.o This continuing education activity is managed and

accredited by Professional Education Services Group in cooperation with AMSUS.

o Neither PESG,AMSUS, nor any accrediting organization support or endorse any product or service mentioned in this activity.

o PESG and AMSUS staff has no financial interest to disclose.o Commercial support was not received for this activity.

Learning Objectives:At the conclusion of this activity, the participant will be able to:

1. Participants will be able to identify the outcome measures for PTSD which show improvement with group therapy for female veterans.

2. Participants will be able to identify the three group components in the 16-week manualized group treatment for PTSD in female veterans.

3.  Participants will be able to identify 3 characteristics of the sample of OEF/OIF female veterans in the manualized group treatment.

Acknowledgementso Department of Defense (DoD) Grant

#PT074309, Award Number W81XWH-08-2-0022o Biomedical Research Institute of New Mexico (BRINM)—non

profit agencyo Study Staff: Christine Chee, Ph.D., Study Coordinator, Jenna

Keller, BS, & Erica Nason, MS, Assessment Technicians, Clifford Qualls, Ph.D., Statistician

o Mentors/Consultants: Terry Keane, Ph.D., Mark W. Miller, Ph.D., Kathleen Haaland, Ph.D.

Overviewo Background Literature o Evidence-based treatments for PTSD

o Exposure & Cognitive o Challenges to Group Treatment

o Study Methodologyo Assessmento Three treatment moduleso Measures

o Results

Research on Treatments for PTSD—Individual Protocols1. Cahill, et.al., (2009). In Effective Treatments for PTSD by

(2nd Ed.) Foa, Keane, Friedman, & Cohen2. 2008 Institute of Medicine

Largest Effect Sizes: o Exposure Therapy

o Prolonged Exposure (PE)—Foa (other models: Keane)o Cognitive Therapy

o Cognitive Processing Therapy (CPT)—Resick

Research on Treatments for PTSD—Individual Protocols

Others treatments with smaller effect sizes:o SITo Assertiveness training o Biofeedback/relaxation training o EMDRo Medications (SSRIs, prazosin)

From: Cahill, et.al., (2009). In Effective Treatments for PTSD by (2nd Ed.) Foa, Keane, Friedman, & Cohen

Impact of Findings

o Cognitive and Exposure Therapies recommended as the 1st line of treatment for PTSD by:o VA/DoD PTSD Treatment Guidelineso ISTSS

o VACO mandated dissemination of CPT and PE trainings to all PTSD providers VA nationally

Standard of Careo Prolonged Exposure—PE

o 10 sessions, 90-minuteso In-session imaginal exposure

o 8 of 10 sessionso Imaginal exposure—30-60 minutes

o In-vivo exposure between sessionso Cognitive Processing Therapy—CPT

o Original 10-12 sessions, 60 minuteso Cognitive restructuring tailored to PTSDo Without Trauma, CPT-C

Cognitive Restructuring Therapyo General education: o Thoughts create emotions

o “Distorted” thoughts cause problematic emotions (e.g., “I’m a failure” depression)

o Aware/challenge/modify distorted thoughts to improve feelings (e.g., “I’m not a failure at everything; I’ve had some successes” hope, positive)

o Most common distortion in PTSD: o Life/death from trauma applied to present

CPT Components

Focus is on PTSD Symptoms Education about rationale & PTSD

12 Sessions, 60 minutes, homework Individual or Group format

Identifying Stuck Points

Assimilation

(about the

past/trauma)

Over-accommodation(about present

and future)

Undoing, (“if only, should have”) guilt or blame about trauma

Conclusions, implications of trauma(“never, always, no one”, all re: 5 themes)

Progression Through WorksheetsAnalyze, Information gathering, feelings

Impact statement ABC sheets Written Account

Challenge Challenging questions Problematic patterns

Change (CBW) Challenging Beliefs Worksheet Themes

5 Cognitive Distortions in a TraumaSafety

Trust

Power/Control

EsteemIntimacy

Prolonged Exposure (PE): Emotional Processing Treatment

Theory:

• TraumaLife-threatening situation• Intense emotions (terror/fear)• Survival requires suppression of emotions, suppression continues after trauma is over• PTSD symptoms result when emotions of trauma not processed

Emotional Processing:

• Addresses fear structure underlying the traumatic memory• Directly challenges avoidance of memory & other situations• “Allows” for corrective information to modify erroneous cognitions

PE Components

Focus is on PTSD Symptoms Education about rationale & common reactions to trauma

10-12 Sessions, 90 minutes, homework SUDs and Breathing retraining

Exposure Therapyo Gets to the heart of the problem—Trauma—in order to healo Repeated imaginal exposure to memory of trauma

o Allows emotionso Allows processing of emotions and habituationo In SAFE environmento Example: Scary Movie

o In-vivo exposure (real life)o Repeated exposure to external situationso Example: Boy on Beach

Imaginal Exposureo Target index trauma (worst)o 30-60 min in-session imaginalo Present tense, SUDS ratings every 5 mino Recall the memory with eyes closedo Repeat the narrative as many times as necessary in allotted

timeo Engage feelings that the memory elicitso Recount as many details as possible

Habituation to Trauma MemoryAn

xiet

y

Sessions

In Vivo Exposureo Teach SUDs (Subjective Units of Distress)o Identify anchor points—0, 50, 100o Develop hierarchical list of avoided situationso Rate each on 1-100 scale (SUDS)o Select 2-3 in 40-60 rangeo At least one practice dailyo Rate pre/peak/post SUDS for each exposureo Stay minimum of 30 min or ½ peak

Research on Treatments for PTSD—Group Protocols

o Sloan (2013) Meta-analysis of 16 CBT Group RCTso Efficacy across all treatments, but not effectivenesso No difference when compared to active controlo Better than no treatmentOther Group Characteristics:o Smaller Effect Sizes than ind literatureo More & longer sessions (typical 90-minute group)o Poorer methodologyo None comparable to PE or CPT—Combo of treatment interventions

o For PE: Only Schnurr (2003) conducted in-session imaginal exposure (TFGT), but only 2/member, 30+ sessons; no difference to PCGT

Problems with Group Treatment Protocolso Baldwin, et al. (2005)—Statistical problems in

group Evidence Supported Treatments (EST)o Clustering within each groupo Violation of assumption of independence of

observations ICC in groupo Inflation of type I errorso 12-68% of EST studies no longer significanto Need larger N, use group as unit of analysis, not

individual

Why Group Therapy?

o Group offers:o Currative Factors—Universality, Instillation of Hope,

Imparting Information, Catharsis, etc., (Yalom, 1975) o For PTSD:o Addresses Isolationo Validation of traumatic experienceo Normalization of traumatic responseso High satisfaction (Sloan, 2013)o Other: efficiency & cost effectiveness

Challenges for Group Researcho Treatment comparable to ind standard of care (PE, CPT)

o Exposure—Dose of therapy: number of in-session exposures (>2)

o Need to address methodological issues unique to group modality research (clustering, ICC)

o Comparison of interventions—cog, exp, skills, etc.–to assess contributions of each treatment component

o Adequate control, active control (present centered therapy)o Group vs. Individual application of interventions

WSDTT Group Treatment Program

PsychEd

Cognitive Skills Sexual Intimacy Exposure

*Castillo (2004). Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols. Cognitive and Behavioral Practice, 11, 352-365.

Clinic Findingso Significant Improvement in Exposure, Cognitive, & Skillso Larger Effect Sizes for Exposure & Cognitiveo Cumulative Improvement across treatmentso See two papers:

o Exposure Group, 33 groups, N=77, Military Medicine, 2012o Cognitive Group, 47 groups, N=271, Behavioral Science, (2013)

DoD Aims & Hypotheseso Aims:

o Add/extend Group Literatureo Randomized Controlled Trialo Establish protocol for systematic exposure in group

o Beyond 2 in-session imaginal exposureso Comparison of treatment blocks

o Exposure, Cognitive, & Skillso Hypotheses:

o Group Tx > wait-list (PTSD—CAPS)—Efficacyo Exposure & Cognitive > Skills (PCL)

Study Designo Participants = OEF/OIF female veterans with PTSDo Assessment:

o Descriptive: Demographics, SCID I/II, LEC, MSEQo Outcome: CAPS, QOLI, SF-36—pre, post, 3-mo, & 6-mo. f/uo Additional: PCL (between tx blocks), Health Care Utilization

(+During active study treatment), Medicationo Exclusion: Psychosis, BPAD, SI/HI, active substanceo Randomized to:o 16-week Tx group (3 Tx Blocks, 3 Ss/group)o 16-wait-list (minimal attention, ind support 2x/mo)

DOD Treatment StudyInitial Assessment & Randomization

Arm 1: Treatment(16 wks)

Post Tx Assessment

3-mo f/u Assessment

6-mo f/u Assessment

Arm 2: Waitlist (16 wks)

Post WL Assess—refer to Tx

Treatment Blocks

Exposure5 sessions

Cognitive5 sessions

Skills4 sessions

Session 1 and 16—Orientation/Wrap Up

97 screened

86 enrolled

44 Treatment

32 completed14 Groups

42 Wait List

35 completed14 Groups

Consort Diagram

Group Characteristics• Randomization by 3• Three patients• Sessions = 90 min(16 wks)

Exposure Block—5 sessionso Combo of PE (Foa) & Flooding (Keane)o Session 1: Rationale, SUDs, id worst trauma, breathing

relaxation, homework (write trauma)o Sessions 2-5: Repeated Imaginal Exposure

o Patients read aloud traumao Guided imaginal exposure (30 min/pt)o Homework: Instructed to re-write same trauma, feedback on

what details to includeo After 3rd in-session exposure, patient reads completed

description daily at home for 2 weeks

Cognitive Block—5 sessionso CPT modelo Session 1: Didactics on cognitive restructuring, homework: 1

page on beliefs 1st of 5 themes—safetyo Session 2-5: Challenge irrational/distorted beliefs, homework—

writing 1 page on different theme each weeko Each session writing/challenging beliefs on 5 themes: safety,

trust, power/control, esteem/intimacy in 4 sessions

Skills Block—4 sessionso Session 1-2: Didactics

o Assertiveness training (passive, assertive, aggressive)o Relaxation training—4 techniques, last ½ hr of group

o Session 3-4: Practiceo Videotaped role-play: practice/review in session

o Passive, aggressive, assertive (fabricated situations)o Assertive only to personal situations,

o Homework: observe self/other’s behaviors, practice relaxation daily, & rate SUDs (1-100)

Demographics & Baseline Characteristics

Demographics (N = 86)

Characteristics

Treatment Armn = 44 n (%)

Wait List Armn = 42 n (%)

Age, M years (SD) 36.7 (12.6) 35.1 (9.2)

Ethnicity

Non-Hispanic White 12 (28.6) 15 (34.1)

Hispanic 18 (42.9) 19 (43.2) Native American 7 (16.7) 8 (18.2)

Education, M (SD) 14.5 (2.2) 14.9 (2.6)

Trauma Characteristics (N = 86)

CharacteristicsTreatment Arm

n = 44 (%)Wait List Arm

n = 42 (%)Life Events Checklist

> 8 trauma types (17 max) 31 (70.5) 29 (69.1)

> 25 trauma incid 28 (63.6) 29 (69.1)

Military Stress Exposure Questionnaire

> 1 mo comb env 34 (77.3) 34 (81.0)

> 1 milt sexual assault 21 (47.7) 19 (45.2)

> 1 X phys harass 26 (59.1) 28 (66.7)

> 1 X verb harass 39 (88.6) 38 (90.5)

Diagnostic Characteristics (N = 86)

CharacteristicsTreatment Arm

(n = 44)Wait List Arm

(n = 42)SCID-I—Current co-morbid Axis I psychiatric disorder Mood disorder 30 (68.2) 23 (54.8) Anxiety disorder 29 (65.9) 23 (54.8) Substance use/abuse 2 (4.6) 1 (2.4)

SCID-II—Current co-morbid Axis II psychiatric disorder Cluster A 24 (54.6) 18 (42.9) Cluster B 10 (22.7) 7 (16.7) Cluster C 8 (18.2) 8 (19.1)

Results

RM-ANOVA on CAPS

Tx Arm = 14 (27%); WL Arm = 14 (17%); *p < .001; ES = 1.72

PTSD Clinical Improvement (CAPS)  Response to

Treatment

% (Mn)

> 20-point

Decrease

% (Mn)

Loss of

Diagnosis

% (Mn)

Total Remission

% (Mn)

Post tx 77.4 (2.3) 63.0 (1.9) 51.9 (1. 6) 13.52 (0.4)

3-month f/u 67.7 (2.0) 54.3 (1.6) 43.8 (1.3) 18.19 (0.6)

6-month f/u 73.1 (2.2) 54.6 (1.6) 46.3 (1.4) 12.62 (0.4)Response to Treatment: > 10-point decrease on CAPS, Loss of Diagnosis: CAPS < 45; Total Remission: total current CAPS < 20

SF36Pre Tx Post Tx 3-month 6-month

M (SD) M (SD) M (SD) M (SD) ES

Physical

Tx Arm 51.3 (14.2) 64.9 (18.0)*** 59.7 (15.6) 62.6 (15.7) 1.08

WL 47.9 (16.2) 49.4 (15.0) ns

Mental

Tx Arm 34.3 (10.0) 54.7 (15.4)*** 48.6 (17.6) 48.9 (14.6) 1.31

WL 31.5 (14.2) 38.3 (17.2)* 0.56

*p < .05, **p < .01, ***p < .001

QOLI

Pre Tx Post Tx 3-month 6-month

M (SD) M (SD) M (SD) M (SD) ES

Tx Arm 1.76 (0.56) 2.33 (0.52)*** 2.05 (0.64) 2.33 (0.71) 1.01

WL 1.60 (0.60) 1.88 (0.82)* 0.63

*p < .05, ***p < .001

PCL for Treatment BlocksPre Post

M (SD) M (SD) ES

Cognitive53.7 (9.2) 47.2 (8.9)* 0.90

Exposure52.2 (8.4) 44.8 (11.9) ** 1.42

Skills51.3 (9.8) 47.8 (9.0) ns

*p < .05, **p < .01

Conclusionso RCT in young, educated, highly traumatized sample of female

OEF/OIF Veteranso Efficacy for a 16-week manualized group treatment protocol for

PTSD: o Group-unit of analysiso Results sustained 6 months after treatmento Clinical improvement indicators comparable to ind PE (Schnurr,

2007)o Established group exposure therapy model, with safety &

efficacyo {Exposure & Cognitive} > Skills

Future Researcho Castillo DoD Study:

o Comparison of 10-session PE individual to 10-session PE group protocol

o C’de Baca DoD Study:o Effectiveness study—comparisons of Exposure Group to

Present Centered Therapy Group

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