protocol

Robert M. Roerich, M.D. announces active recruitment for a
police and veterans Post-Traumatic Stress Disorder (PTSD)
clinical trials study. It is the first such study which compares the
use of a new mental imagery treatment of PTSD with standard
treatment.

Mental imagery treatment of PTSD in Police Officers and Veterans

Purpose: The purpose of the proposed study is to evaluate the
efficacy of mental imagery therapy for treating Post-Traumatic
Stress Disorder (PTSD) in police officers, with or without military
experience and veterans. We propose to evaluate mental
imagery treatment in comparison with standard therapy used by
mental health professionals currently.

The study is a randomized clinical trial involving 90 retired or
active duty police officers and veterans. All subjects, even
self-referrals, will enter the study through referrals by mental
health clinicians at the participating sites. Following informed
consent, subjects will be screened for inclusion and exclusion
diagnoses. If they meet these criteria and agree to participate,
they will be randomly assigned to one of the two treatments or
a control group, which will be monitored for 8 weeks. Subjects
will be assessed before treatment, immediately following
treatment, and 2 months after the end of treatment. The
primary outcome is PTSD severity. Exploratory outcomes
include associated features of PTSD, such as psychosocial
functioning, quality of life, physical health, satisfaction with
treatment, and service utilization.

Condition: Post-Traumatic Stress Disorders

Treatment or Intervention: Psychotherapy treatment

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control, Parallel
Assignment, Efficacy Study

Official Title: Mental imagery treatment of PTSD in Police Officers
and Veterans

Further study details:

Mental imagery treatment will be tested to treat symptoms of
PTSD in survivors of various types of trauma. Our study will
present data on the efficacy of mental imagery treatment of
PTSD in police officers and veterans.

Patients in this study will be randomized to one of two groups.
Group A will receive mental imagery therapy. Group B will receive
standard therapy by their therapist. Patients in Groups A will
receive one hour of mental imagery therapy. Patients in Groups
A will have one non-therapeutic study visit before treatment and
seven after treatment at weekly intervals. Patients in Group B
will have one non-therapeutic study visit weekly during the 8
week study. These visits will address diagnosis and assessment.
Study visits will include assessments of PTSD symptoms, sleep
symptoms, and level of impairment.

Eligibility

Genders eligible for study: both

Ages eligible for study: 18-65

Accepts healthy volunteers

Criteria

Inclusion criteria:

males and females age 18-65

good physical health

willing and able to provide informed consent

diagnosis of PTSD from combat or civilian trauma

exhibit clinically significant trauma-related symptoms.

Exclusion criteria:

Inability to comply with study procedures or assessments

Past head trauma involving loss of consciousness, or amnesia
greater than 24 hours. This magnitude of head trauma could
contribute to psychopathology and brain structure in a manner
different than PTSD thereby confounding results.

High risk for homicide or suicide

Current or past history of other axis I disorders, including
schizophrenia, schizoaffective disorder, bipolar disorder, or
dementia.

Participants with a co-morbid history of other Axis I disorders,
including major depression, dysthymia, or panic disorder will be
included.

Participants who are doing well on medication

Expected total enrollment: 90

Location and contact information:

Robert M. Roerich, M.D.
820 North Fourth Street, Suite 2
Steubenville, Ohio 43952
Phone: 740-283-4520
Fax: 740-283-3010

E-mail: roerich@senticon.us