Yale School of Medicine

Research Studies at Yale

Research Studies at Yale

A Modified Version of Cognitive Processing Therapy for Treatment of Patients Diagnosed With Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence or Alcohol Abuse

For Patients For Researchers

Conditions: Alcohol Dependence; PTSD

What is the purpose of this trial?

Objective: To evaluate the efficacy of a modified version of cognitive processing therapy - cognitive (CPT-C) versus historical controls in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid posttraumatic stress disorder (PTSD) and alcohol dependence or alcohol abuse.

Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD (measured by the [CAPS and PCL] scores) compared to historical controls in patients with alcohol dependence or alcohol abuse and PTSD.

Design: This is a 12-week outpatient intervention of modified CPT-C versus treatment as usual in individuals with PTSD and alcohol dependence or alcohol abuse. Treatment consists of weekly sessions lasting approximately 60 minutes.


Dates: March 2008 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

Inclusion Criteria:

  1. Males and females between the ages of 21-65 years old.
  2. Current alcohol dependence or alcohol abuse, as determined by the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Not requiring detoxification from alcohol and able to remain abstinent for 3 days prior to treatment, and the stated goal of study is abstinence. Abstinence no more than past 29 days. Primary substance dependence diagnosis of alcohol dependence or alcohol abuse.
  3. Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS; Blake et al. 1995).
  4. Participants on psychiatric medication must be on a stable regimen for at least 2 weeks before treatment begins.
  5. Veteran eligible for VA services.
  6. Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

  1. Psychotic symptoms as determined by the SCID.
  2. Serious current psychiatric symptoms, such as suicidal ideation or homicidal ideation.
  3. Opioid dependence as determined by the SCID.
  4. Legal charges pending with potential of incarceration.
  5. Unstable, serious medical condition or one requiring acute medical treatments, or anticipation of hospitalization for extended care.

Sponsor: Yale University
Phase: Phase 2/Phase 3

First Received: March 13, 2008 
Last Updated: June 10, 2009
Clinicaltrials.gov ID: NCT00639288
Study HIC # 0803003634

Conditions: Alcohol Dependence; PTSD

Intervention: Other: modified CPT-C

What is the purpose of this trial?

Objective: To evaluate the efficacy of a modified version of cognitive processing therapy - cognitive (CPT-C) versus historical controls in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid posttraumatic stress disorder (PTSD) and alcohol dependence or alcohol abuse.

Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD (measured by the [CAPS and PCL] scores) compared to historical controls in patients with alcohol dependence or alcohol abuse and PTSD.

Design: This is a 12-week outpatient intervention of modified CPT-C versus treatment as usual in individuals with PTSD and alcohol dependence or alcohol abuse. Treatment consists of weekly sessions lasting approximately 60 minutes.


Dates: March 2008 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 21 Years - 65 Years
Gender Eligible: Both

Inclusion Criteria:

1. Males and females between the ages of 21-65 years old.

2. Current alcohol dependence or alcohol abuse, as determined by the Structured Clinical
Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Not requiring
detoxification from alcohol and able to remain abstinent for 3 days prior to
treatment, and the stated goal of study is abstinence. Abstinence no more than past
29 days. Primary substance dependence diagnosis of alcohol dependence or alcohol
abuse.

3. Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS;
Blake et al. 1995).

4. Participants on psychiatric medication must be on a stable regimen for at least 2
weeks before treatment begins.

5. Veteran eligible for VA services.

6. Ability to participate psychologically and physically, able to give informed consent
and complete assessments, and participate in study procedures.

Exclusion Criteria:

1. Psychotic symptoms as determined by the SCID.

2. Serious current psychiatric symptoms, such as suicidal ideation or homicidal
ideation.

3. Opioid dependence as determined by the SCID.

4. Legal charges pending with potential of incarceration.

5. Unstable, serious medical condition or one requiring acute medical treatments, or
anticipation of hospitalization for extended care.


Additional Location

Connecticut

Sponsor: Yale University
Phase: Phase 2/Phase 3

First Received: March 13, 2008 
Last Updated: June 10, 2009
Clinicaltrials.gov ID: NCT00639288
Study HIC # 0803003634

Participate in this trial

For more information about this trial, contact:

Elissa McCarthy, Ph.D.
203-932-5711 Ext. 7437
elissa.mccarthy@va.gov

Elizabeth Ralevski, Ph.D.
203-932-5711 Ext. 4282
elizabeth.ralevski@yale.edu


Yale Researcher

Petrakis, Ismene Leonida
Principal Investigator  

HIC # 0805003779