Integrated Cognitive Behavioral Therapy (ICBT) for Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders

The proposed research will evaluate the safety and practicality, feasibility, and efficacy
of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT
(a revised edition of what was formerly called cognitive behavioral therapy for
posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery
by counselors employed in community addiction treatment programs and offered in conjunction
with standard community addiction treatment. The investigators have completed a Stage I
Safety & Practicality Study, Feasibility Study and Pilot Randomized Controlled Study
(comparing ICBT versus a control condition) in community addiction treatment and for all
studies found that ICBT was safe and effective in reducing PTSD symptoms, improving
retention, and in reducing substance use. The present study proposes to conduct a Stage I
study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and
Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The
investigators will modify the existing ICBT for testing in a VA setting, and use a combined
individual and group modality.

There are 3 specific aims for this study, and hypotheses for each aim:

Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and
substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month
follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).

- This aim is to test the effect of ICBT on symptoms of PTSD and substance use disorders
among returning OEF/OIF/OND Veterans seen in a VA clinic. ICBT will be tested with 16
Veterans who meet criteria for both PTSD and substance use disorder at the PTSD or SATP
clinics. The investigators propose that ICBT will result in significant reductions in
PTSD and substance use severity from baseline to follow-up assessment.

- Hypothesis 1: Participants receiving ICBT will have significant reductions in PTSD
symptom severity as assessed by their Clinician Administered PTSD Scale (CAPS) score
from baseline to a 6-month follow-up assessment.

- Hypothesis 2: Participants receiving ICBT will have significant reductions in substance
use as assessed by their Addiction Severity Index (ASI) drug and alcohol severity
composite scores from baseline to a 6-month follow-up assessment.

Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I
Phase II).

-Based on experience and lessons learned in Stage I Phase I, the investigators will refine
and improve the ICBT approach and study methods for teh Stage I Phase III randomized pilot
trial.

Aim 3: To conduct a randomized controlled pilot trial comparing ICBT plus standard Substance
Abuse Treatment Program (SATP) or PTSD care versus standard SATP or PTSD care alone, with
OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance
use and PTSD outcomes at post treatment and 3-month post treatment follow-up (Stage I Phase
III: Randomized Pilot Trial).

- The efficacy of ICBT will be tested among 64 Veterans who screen positive for both
disorders and are randomly assigned to either ICBT or standard treatment.

- Hypothesis 1: Participants receiving ICBT plus standard care will have greater
reductions in PTSD symptoms, as assessed by their CAPS score from baseline to
follow-up, than participants receiving standard care alone.

- Hypothesis 2: Participants receiving ICBT plus standard care will have greater
reductions in substance use, as assessed by their ASI drug and alcohol severity
composite scores from baseline to follow-up, as compared to participants receiving
standard care alone.

Potential subjects will be receiving PTSD or substance use treatment services at the
Providence Veterans Affairs Medical Center (PVAMC), and will be referred by clinicians in
these respective clinics for participation in the study. Patients will be approached by the
clinic staff about potential interest in the study. If they wish to learn more about the
study, the research coordinator (an on-site employee) is contacted, a suitable time
arranged, and the patient is engaged in the process of informed consent.

If consent is granted, the subjects completes the baseline assessment. The baseline
assessment consists of measures gathered via interview by a member of the research team,
self-administered surveys completed directly by the subject, and review of the subject's
medical record to extract demographic, substance use, and treatment history information, as
well as chart diagnoses.

The interview portion of the assessment consists of:

- Standardized interviews designed to assess PTSD and Axis I DSM-IV substance use
disorders: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical
Interview for DSM-IV-TR, Patient Edition (SCID-I/P) Section E.

- A urine screen and breathalyzer to test for alcohol and other drugs.

- Standardized follow-back method for gathering data on recent alcohol and drug use:
Time-line Follow-back Calendar (TLFB).

The self-administered portion of the assessment consists of measures designed to assess:

- Alcohol and drug use, as well as associated problems in other life areas such as
medical, employment, legal, social, and psychiatric: Addiction Severity Index (ASI).

- Depression: Patient Health Questionnaire-9 (PHQ-9).

If the subject continues to meet criteria for PTSD (i.e. the CAPS interview confirms
diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is eligible to
participate. For Stage I Phase I, the patient would receive the ICBT therapy. For Stage I
Phase III, the patient would be randomized to receive either the ICBT therapy plus standard
treatment, or standard treatment only.

Research assessments are then also conducted at three months and six months post baseline
assessment. This follow-up assessment will consist of the same measures administered at
baseline, with the exception of the SCID interview.

The investigators plan to enroll approximately 16 subjects in the Stage I Phase I and to
randomize approximately 64 subjects in the Stage I Phase III of the study. The subject
outcome and program experiences with the protocol will be used in planning the subsequent
federal grant application for a randomized controlled trial.

Inclusion Criteria:

1. OEF/OIF/OND Veteran status;

2. Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a
total symptom score of 44 or more;

3. Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the
Structured Clinical Interview of DSM-IV Section E (SCID-E);

4. Willing and able to provide informed consent;

Exclusion Criteria:

1. Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if
their symptoms are stable and they are well connected with appropriate mental health
services);

2. Psychiatric hospitalization or suicide attempt in the past month (however, if the
hospitalization or attempt was directly related substance intoxication or
detoxification and ther person is currently stable, they are eligible);

3. Medical or legal situations are unstable such that ability to participate in the full
duration of the study seems unlikely.