Evaluation of Glucocorticoid-Related Prognostic and Diagnostic PTSD Biomarkers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/5/2015 |
| Start Date: | January 2016 |
| End Date: | December 2019 |
| Contact: | Rachel Yehuda, PhD |
| Email: | Rachel.Yehuda@va.gov |
| Phone: | (718) 584-9000 |
Although there are effective psychotherapies for combat-related PTSD, symptoms persist for
some Veterans even after treatment. Identifying biological alterations associated with
treatment response is essential to treatment development and can be accomplished through
longitudinal evaluation. Longitudinal assessments permit a distinction between recovery,
persistence, and resistance to the development of PTSD. This proposal aims to identify
molecular and endocrine diagnostic and prognostic biomarkers associated with PTSD and
recovery by comparing biological markers in 60 OIF/OEF/OND Veterans with PTSD before and
after treatment with cognitive processing therapy (CPT-C). The direct manipulation of PTSD
symptoms over the course of 12 weeks of psychotherapy will result in a sample with a
variable range of symptom improvement. At treatment end, the PTSD group will be subdivided
into those no longer meeting DSM-5 criteria for PTSD and those who still have PTSD. 30
Veterans exposed to similar levels of combat, but who never developed PTSD will also be
studied at two times, 12 weeks apart. It will therefore be possible to determine 1) whether,
and in what way combat Veterans who recover following psychotherapy differ biologically from
those who fail to recover, and 2) whether, and in what manner those who recover are similar
to those who never developed PTSD, at pre and/or post-treatment.
some Veterans even after treatment. Identifying biological alterations associated with
treatment response is essential to treatment development and can be accomplished through
longitudinal evaluation. Longitudinal assessments permit a distinction between recovery,
persistence, and resistance to the development of PTSD. This proposal aims to identify
molecular and endocrine diagnostic and prognostic biomarkers associated with PTSD and
recovery by comparing biological markers in 60 OIF/OEF/OND Veterans with PTSD before and
after treatment with cognitive processing therapy (CPT-C). The direct manipulation of PTSD
symptoms over the course of 12 weeks of psychotherapy will result in a sample with a
variable range of symptom improvement. At treatment end, the PTSD group will be subdivided
into those no longer meeting DSM-5 criteria for PTSD and those who still have PTSD. 30
Veterans exposed to similar levels of combat, but who never developed PTSD will also be
studied at two times, 12 weeks apart. It will therefore be possible to determine 1) whether,
and in what way combat Veterans who recover following psychotherapy differ biologically from
those who fail to recover, and 2) whether, and in what manner those who recover are similar
to those who never developed PTSD, at pre and/or post-treatment.
This project aims to identify molecular biomarkers of PTSD diagnosis, symptom severity and
recovery in treatment-seeking Operation Enduring Freedom/Operation Iraqi Freedom/Operation
New Dawn (OEF/OIF/OND) Veterans. The longitudinal design will also permit identification of
biomarkers that predict positive outcome to psychotherapy. The aims will be accomplished by
assessing biomarkers immediately before, and then after, treatment with CPT-C, a 12 week
cognitive behavioral treatment. A group of similarly-exposed Veterans who never developed
PTSD (PTSD-resistant) will also be recruited and studied at two time points, 12 weeks apart.
Treatment will result in a sample with a variable range of symptom improvement. Veterans in
the PTSD-resistant group are expected to maintain their low symptom level over the 12 weeks,
but may also show natural variability. Treatment completers in the PTSD group will be
further subdivided based on whether they meet diagnostic criteria for PTSD at
post-treatment. If a marker distinguishes the PTSD sub-groups at pre-treatment, it will be
defined as a prognostic indicator of recovery. The investigators will further compare the
PTSD groups to the PTSD-resistant group in order to determine whether biomarkers are similar
in persons who have never developed PTSD and persons who no longer meet diagnostic criteria
for PTSD following treatment. By comparing the groups at pre-treatment, when they differ in
PTSD diagnostic status and at three months later when the responders will have significantly
improved, it will be possible to distinguish biomarkers of PTSD diagnosis, symptom severity
and recovery.
recovery in treatment-seeking Operation Enduring Freedom/Operation Iraqi Freedom/Operation
New Dawn (OEF/OIF/OND) Veterans. The longitudinal design will also permit identification of
biomarkers that predict positive outcome to psychotherapy. The aims will be accomplished by
assessing biomarkers immediately before, and then after, treatment with CPT-C, a 12 week
cognitive behavioral treatment. A group of similarly-exposed Veterans who never developed
PTSD (PTSD-resistant) will also be recruited and studied at two time points, 12 weeks apart.
Treatment will result in a sample with a variable range of symptom improvement. Veterans in
the PTSD-resistant group are expected to maintain their low symptom level over the 12 weeks,
but may also show natural variability. Treatment completers in the PTSD group will be
further subdivided based on whether they meet diagnostic criteria for PTSD at
post-treatment. If a marker distinguishes the PTSD sub-groups at pre-treatment, it will be
defined as a prognostic indicator of recovery. The investigators will further compare the
PTSD groups to the PTSD-resistant group in order to determine whether biomarkers are similar
in persons who have never developed PTSD and persons who no longer meet diagnostic criteria
for PTSD following treatment. By comparing the groups at pre-treatment, when they differ in
PTSD diagnostic status and at three months later when the responders will have significantly
improved, it will be possible to distinguish biomarkers of PTSD diagnosis, symptom severity
and recovery.
Inclusion Criteria:
- Male or female (age 18+) Veterans, who experienced a deployment-related trauma and
have capacity to provide informed consent may be considered for participation.
- In the PTSD group, the Veteran must have a primary diagnosis of PTSD (CAPS total
score 60) with a minimum duration of six months.
- Veterans in the resistant group must have no lifetime diagnosis of PTSD (CAPS total
score < 30) or other psychiatric disorder.
- PTSD participants may meet criteria for a current co-morbid anxiety, depressive, or
bipolar II diagnosis, but may not have a primary psychotic illness, bipolar I
disorder, OCD, or meet criteria for a substance abuse or dependence within the past
three months.
- Veterans in the comparison group must have also been deployed to Iraq or Afghanistan,
but have no lifetime diagnosis of PTSD according to DSM-5, as measured by the CAPS,
and no other psychiatric disorder, current or lifetime including substance use
disorders.
Exclusion Criteria:
- Current or lifetime diagnosis of schizophrenia-spectrum, bipolar-1 or obsessive
compulsive disorder.
- History of alcohol or other drug abuse or dependence within the previous three
months.
- Use of psychotropic medications - not having been stabilized at the current dose for
at least 3 weeks.
- Participants cannot be enrolled if using systemic steroids.
- Medically unstable condition that would contraindicate participation or that could
interfere with the interpretation of biological measurements.
- These include unstable insulin dependent diabetes, poorly controlled seizure
disorder, moderate or severe traumatic brain injury (TBI), or laboratory indices
that suggest clinically significant or unstable illness as determined by
self-report or CPRS review.
- Ongoing abuse or current repeated trauma exposure or current psychosocial problems
that might interfere with treatment or adherence to study procedures.
- Serious suicide risk as assessed by a rating of 4 on the Beck Depression Inventory-II
or assessed to be at risk for self-injury as determined initially by independent
evaluator or study physician (Dr. Bierer, and monitored at each session by the study
clinician).
- Women who have been pregnant for 16 weeks or more will be excluded from study so as
to maximize the probability that they will be able to complete the study.
- Current cigarette smoking that exceeds two packs per day.
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