|
|
View Clinical Trial (Medical Research Study)
|
Cognitive Therapy for PTSD in Addiction Treatment - NCT00685451-03301 (Clinical Trial 223026)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy223026.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Concord |
|
State:
|
|
NH |
| Zip Code: |
|
03301 |
| Conditions: |
|
Stress Disorders, Post Traumatic - Substance-Related Disorders |
| Purpose: |
|
The purpose of this phase of the study is to assess the feasibility of a cognitive
behavioral therapy for post-traumatic stress disorder (PTSD) in persons receiving outpatient
services at an addiction treatment program. The next phase of the study will be a more
rigorous investigation of the efficacy of the PTSD therapy within addiction treatment
settings.
|
| Study summary: |
|
PTSD is a common co-occurring disorder with substance use disorders (SUDs). When present,
PTSD causes more negative outcomes in treatments designed to address substance use
disorders. These negative outcomes include: 1) Early drop-out from treatment; 2) More
frequent relapse to alcohol and other drugs; 3) Greater difficulty utilizing group therapies
and self-help recovery groups; 4) Worsening of PTSD symptoms; and 5) Addiction treatment
clinician distress. Nonetheless, the traditional practice in addiction treatment programs
has been to address the problems of addiction, and delay treatment for PTSD and other
psychiatric conditions. The evidence for negative outcomes for persons with co-occurring
PTSD and SUDs challenges this practice, and suggests the need for new intervention
strategies. A promising intervention for PTSD has emerged in another at-risk and vulnerable
population of persons already receiving treatment for their "primary" disorder. This is a
cognitive behavioral therapy for PTSD in persons with severe mental illness (SMI). Pilot
studies with this intervention have demonstrated effectiveness, that it is well tolerated by
patients, and that it fits within existing treatment services. Given the high prevalence of
co-occurring PTSD and SUDs in addiction treatment settings (33-59%), the negative outcomes
associated with this comorbidity, and the potential availability of a promising
intervention, a stage one feasibility study appears warranted.
Patients admitted to an addiction treatment program are routinely screened for PTSD using a
brief self-report survey, the PTSD Checklist (PCL). These forms are collected by clinical
staff of the treatment program and scored for PTSD diagnostic criteria. If a patient exceeds
threshold criteria (PCL score of greater than or equal to 44) they are approached by a
clinical staff member about their potential interest in the study. If they wish to learn
more about the study the PI or designee is contacted, a suitable time arranged, and the
patient approached for their interest in consenting to the study.
If consent is granted, the subject is interviewed by a member of the research team and
demographic, substance use, and treatment history information is extracted from the
subject's medical record. The interview consists of standardized procedures (Clinician
Administered PTSD Scale [CAPS], SCID-Axis II borderline personality disorder) designed to
assess PTSD and other commonly associated psychiatric disorders. A urine screen and
breathalyzer are conducted to test for alcohol and other drugs. Self-report measures of
depression (Beck Depression Inventory-II [BDI-II]), anxiety (Beck Anxiety Inventory [BAI]),
alcohol and drug use (Addiction Severity Index [ASI] and Time-line Follow-back Calendar),
treatment readiness for substance use (Stages of Change Readiness and Treatment Eagerness
Scale [SOCRATES]) and for PTSD (SOC-PTSD), HIV risk (HIV-risk Screening Instrument [HSI]),
and treatment utilization (Recent Treatment Survey [RTS]) are also administered. If the
subject again meets criteria for PTSD (CAPS confirms diagnosis of DSM-IV PTSD), he or she is
presented with the opportunity to receive the PTSD cognitive behavioral therapy. In either
case, the subject receives $25 for participating in the interview.
The cognitive behavioral therapy is conducted in individual sessions, approximately 50
minutes in duration. The therapy is manual-guided, focused on the PTSD symptoms only, and
designed to work in conjunction with the addiction treatment program services. The therapy
is offered in weekly sessions, for 12-14 total sessions. At monthly intervals, the subject
will complete the RTS and a trauma event checklist based on the PCL, and will be tested for
alcohol (breathalyzer) and drug use (urine screen). The subject will also complete the
Working Alliance Inventory (WAI - client version) after the second PTSD therapy session.
At completion of the PTSD therapy the patient will again be interviewed by a member of the
research team. The post-therapy assessment will consist of the CAPS, the Time-line
Follow-back, BAI, BDI-II, RTS, ASI, HSI, and a measure of treatment satisfaction (Client
Satisfaction Questionnaire [CSQ-8]). The subject is again compensated $25 for the
post-therapy assessment. At three months post completion, the subject participates in a
follow-up interview. This interview will consist of the same measures used at the
post-therapy assessment, with the exception of the CSQ-8 and with the addition of the trauma
event checklist. The subject is again compensated $25 for their participation in the
follow-up interview. All research activities, including all assessments and therapy
sessions, will be conducted on-site at the addiction treatment program.
We plan to enroll approximately 100 subjects in the feasibility phase of the study. The
subject outcome and program experiences with the protocol will be used in planning the
subsequent pilot trial phase of the study. The pilot trial will be a larger, randomized
controlled trial comparing the study cognitive behavioral therapy with a matched-attention
control condition. |
| Criteria: |
|
Inclusion Criteria:
- At least 18 years old;
- Actively enrolled in intensive outpatient addiction services;
- Diagnosis of PTSD; and
- Willing and able to provide informed consent.
Exclusion Criteria:
- Acute psychotic disorder;
- Psychiatric hospitalization or suicide attempt in the past 2 months;
- Known impending court appearance or legal circumstance that may result in
incarceration within next 8 months; and
- Known medical condition that would likely cause study withdrawal in the next 8
months. |
|
|
|
| Study is available at: |
|
Fresh Start at Concord Hospital
Concord, NH 03301
United States
Primary Contact:
Stephanie C. Acquilano, M.A.
Email: stephanie.acquilano@dartmouth.edu
Phone: 603-271-5747 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|