Expectation of Unpleasant Events in Anxiety Disorders



Status:Recruiting
Conditions:Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:4/6/2019
Start Date:February 20, 2003
Contact:Marilla Geraci, R.N.
Email:geracim@intra.nimh.nih.gov
Phone:(301) 496-6470

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Predictability and Aversive Expectancies in Anxiety and Depressive Disorders

Fear and anxiety are normal responses to a threat. However, anxiety is considered abnormal
when the response to the threat is excessive or inappropriate. This study will examine
changes in the body and brain that occur during unpleasant learning experiences in healthy
volunteers with high, moderate, and low levels of anxiety.

A high degree of generalized anxiety is a component of many anxiety disorders and is regarded
as a marker of vulnerability for these disorders. People with anxiety disorders and
individuals with high degrees of anxiety have inappropriate expectations of unpleasant
events. This study will investigate the development of expecting unpleasant events in healthy
volunteers with varying degrees of anxiety using aversive conditioning models. A later phase
of the study will enroll participants with anxiety disorders and compare their responses to
those of healthy volunteers.

Patients who meet criteria for an anxiety disorder, and healthy volunteers who have no
history of psychiatric or major medical illness will be enrolled in this study. Volunteers
will come to the NIH Clinical Center three times for outpatient testing....

High-generalized anxiety is a concomitant of many anxiety disorders and is often regarded as
a vulnerability marker for these disorders. One characteristic of patients with anxiety
disorders and high trait-anxious individuals is inappropriate expectancies of aversive
events. The overall aim of the present protocol is to investigate mechanisms that may promote
the development of these aversive expectancies using expectancy-based, associative-learning
models.

During aversive conditioning in which a phasic explicit-cue (e.g., a light) is repeatedly
associated with an aversive unconditioned-stimulus (e.g., a shock), the organism develops
fear to the explicit cue as well as to the environmental context in which the experiment took
place. We have obtained preliminary evidence suggesting that contextual fear represents
aspects of aversive states that are central to anxiety disorders. In this protocol, we seek
further evidence for the relevance of contextual fear to mood anxiety disorders.

One important determinant of contextual fear in both humans and animals is predictability:
contextual fear increases when aversive events (e.g., electric shock) are unpredictable, as
opposed to when they are predictable. The present protocol will examine the role of
predictability of aversive states and of conditioning on threat appraisal in individuals with
mood and anxiety disorders..

A second aim is to examine the interaction between experimentally-induced anxiety and
cognitive processes, more specifically working memory, in mood and anxiety disorders.

A final aim is to investigate whether the relationship between heightened emotional
reactivity to threat and impaired cognitive functions under threat in patients with anxiety
disorders is susceptible to treatment with cognitive behavioral therapy (CBT).

- INCLUSION CRITERIA:

- Inclusion criteria for both patients and healthy controls

- All subjects must be able to give written informed consent prior to participation
in this study.

- PATIENTS ONLY: May have DSM-IV-TR diagnoses of an anxiety disorder (GAD; SAD;
Panic disorder; specific phobia) or mood disorder (MDD; BP).

- PATIENTS ONLY: May be taking the mood stabilizers, Depakote or Lithium Carbonate.

- Speaks English or Spanish fluently (subjects with Major Depressive Disorder,
healthy volunteers)

EXCLUSION CRITERIA:

- Exclusion criteria for healthy subjects

- Female subjects who are currently pregnant

- Subjects who meet DSM-IV criteria for current alcohol or substance abuse

- Subjects with a history of alcohol or substance dependence within 6 months prior
to screening

- Current Axis I psychiatric disorders as identified with the Structured Clinical
Interview for DSM-IV-TR axis disorders, non-patient edition (SCID-np). Past
history of any psychotic disorder or bipolar disorder.

- I-Q<80

- Medical illnesses (such as diabetes or hypertension) or neurological illnesses
(such as carpal tunnel syndrome for shocks to be delivered on affected arm;
organic brain impairment; seizure disorder) likely to interfere with the study.

- Subjects who are on a medication that may interfere with the study.

- Employee of NIMH or an immediate family member who is a NIMH employee.

- Exclusion criteria for patients

- Patients who would be unable to comply with study procedures or assessments;

- Female patients who are currently pregnant;

- Patients who meet DSM-IV criteria for current alcohol or substance abuse

- Subjects with a history of alcohol or substance dependence within 6 months prior
to screening;

- Patients who are on a medication (other than mood stabilizers lithium carbonate
or Depakote) that may interfere with the study

- Medical illnesses (such as diabetes or hypertension) or neurological illnesses
(such as carpal tunnel syndrome; organic brain impairment; seizure disorder)
likely to interfere with the study.

- Patients will be excluded if they have a current or past history of, delirium,
dementia, amnestic disorder, any of the pervasive developmental disorders; or
cognitive impairment.

- Current Axis I psychiatric disorders as identified with the Structured Clinical
Interview for DSM-IV-TR axis disorders, non-patient edition (SCID) with the
exception of the mood and anxiety disorders. Past history of any psychotic
disorder or bipolar disorder..

- IQ<80

- Not speaking English (except patients with MDD who may be Spanish-speaking);
Non-English speaking patients with anxiety disorders will not be recruited
because the anxiety-related instruments of interest are not validated in Spanish.
Subjects with an anxiety disorder who do not speak English fluently will be
excluded because two of our primary anxiety-related instruments of interest (PSWQ
and POMS) are not validated in languages other than English.

- Employee of NIMH or an immediate family member who is an NIMH employee.

- Additional exclusion criteria for the exercise substudy:

- History of exercise intolerance

- History of heart disease

- History of pulmonary disease, other than controlled, non-excercise-induced asthma

- History of uncontrolled diabetes

- Resting heart rate > 90 BPM

- Resting systolic pressure> 140mmHG or diastolic blood pressure>90mmHg

- Peripheral condition making completion of the exercise impossible, such as severe
osteoarthritis or chronic pain

- Clinically significant abnormal EKG as determined by MD or NP

- Additional exclusion criteria for the active avoidance task

- Color blindness
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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from
Bethesda, MD
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