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Completed

NCT Number: NCT01542229

PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness)

As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among Veterans and this symptom presentation clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated that these data will establish a much needed clinical course of action for what is considered a vulnerable yet highly underserved patient population.

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Key information

Conditions

Post Traumatic Stress Disorder Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

About this study

The overarching aim of this proposal is to compare the efficacy of Prolonged Exposure for posttraumatic stress disorder (PTSD) plus treatment as usual (PE+TAU) relative to treatment as usual (TAU) alone using a randomized, between groups, repeated measures design. One hundred fifty six (156) ethnically/racially diverse male and female Veterans with posttraumatic stress disorder (PTSD) and severe mental illness (SMI) will be recruited from the Charleston VA and affiliated Community Based Outpatient Clinics (CBOCs) during the study time frame. For the investigators' study purposes, severe mental illness (SMI) is defined as (1) the presence of a past year Diagnostic Statistical Manual (DSM-IV) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or severe depression (2) resulting in persistent impairment in self-care, work, or social functioning. Veterans will be randomized 1:1 to one of two conditions: PE+TAU or TAU. The active intervention phase is 12 weeks. Veterans randomized to treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling and Veterans randomized to prolonged exposure (PE) plus treatment as usual (TAU) will receive 12 weekly sessions of prolonged exposure (PE) in addition to treatment as usual (TAU). All participants will be assessed at baseline, 6 weeks, post-treatment, and at 3 and 6 months. Additionally, they will complete two self report forms during sessions 3, 6, and 9.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Posttraumatic Stress Disorder (PTSD) on the Clinician Administered PTSD Scale (CAPS; Blake et al., 1990);
  • A confirmed diagnosis of a psychotic disorder, bipolar disorder, or severe unipolar depression on the Mini Neuropsychiatric Interview (MINI; Sheehan et al., 1998).

Exclusion criteria

  • Having a household member who is already enrolled in the study;
  • Active psychosis, mania, or dementia at screening;
  • Suicidal ideation with clear intent;
  • Current substance dependence; and
  • Concurrent enrollment in another clinical trial for PTSD or depression.

Treatment and study plan

Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU)

Behavioral

12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual

Treatment as Usual (TAU)

Behavioral

Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling

Primary outcomes

  1. Posttraumatic Stress Disorder (PTSD) Checklist (PCL)

    Time frame: pre to post treatment (12 weeks)

    The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL were used, and total scores range from 17 to 85 with higher scores indicative of greater PTSD severity.

  2. Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)

    Time frame: pre to post treatment (12 weeks)

    The Clinician Administered PTSD (Posttraumatic Stress Disorder; PTSD) Scale (CAPS) is a 30-item structured interview that corresponds to DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assess symptoms over the past week/month. The CAPS was used to measure current PTSD (yes/no diagnosis) as well as total PTSD severity (scores range 0-136, with higher scores indicative of more severe PTSD).

Secondary outcomes

  1. Beck Depression Inventory-II (BDI-II)

    Time frame: pre to post treatment (12 weeks)

    The Beck Depression Inventory-II is a 21 item measure of depressive severity. Total BDI-II scores were used. Scores on the BDI-II range from 0 to 63 with higher scores indicative of greater symptom severity.

  2. Brief Psychiatric Rating Scale-Extended (BPRS-E)

    Time frame: pre to post treatment (12 weeks)

    The Brief Psychiatric Rating Scale-Extended (BPRS-E) is a 24 item measure of psychopathology across several dimensions (i.e., delusions, motor hyperactivity, withdrawal and blunted affect, self-neglect, etc.) and is a commonly used measure for severely and persistently ill patient populations. Total BPRS scores were used and can range from 24 (score of 1 on all items, symptom not present) to 168 (score of 7 on all items, extremely severe).

  3. Veterans SF 12 Health Survey (SF-12)

    Time frame: pre to post treatment (12 weeks)

    The Veterans SF 12 Health Survey (SF-12) is a valid and reliable instrument to measure quality of life and/or functional status in Veterans. The SF-12 was used to track changes in general mental [MCS mental component score) and physical health (PCS physical component score) functioning. Scores on the SF-12 scales range from 0 to 100 once converted and higher scores are indicative of better mental and physical health. The MCS score was used in the current analyses.

  4. Pittsburgh Seep Quality Index

    Time frame: pre to post treatment (12 weeks)

    The Pittsburgh Sleep Quality Index (PSQI) is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with ratings of 5 or higher indicative of poor sleep quality. Item 9, assessing overall quality of sleep, was used in current analyses. Scores on this item range from 0 to 3, with higher scores indicative of worse sleep quality.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Improving PTSD Service Delivery for Veterans With Severe Mental Illness

Acronym: PTSD/SMI

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 2, 2012
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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