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Expectation of Unpleasant Events in Anxiety Disorders

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic startle
Electric Shock
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorders focused on measuring Anxiety Disorder, Psychophysiology, Shock Threat, Context Conditioning, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder, GAD, Healthy Volunteer, HV

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 fluently 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 Employee of NIMH or an immediate family member who is an NIMH employee. Additional exclusion criteria for the active avoidance task Color blindness

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Threat conditions

Arm Description

acoustic startle and shock device

Outcomes

Primary Outcome Measures

Startle Reflex
startle reflex
Performance on cognitive tasks
performance on cognitive tasks

Secondary Outcome Measures

state and trait questionaires
state and trait questionnaires
Skin conductance
skin conductance

Full Information

First Posted
February 21, 2003
Last Updated
August 15, 2022
Sponsor
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00055224
Brief Title
Expectation of Unpleasant Events in Anxiety Disorders
Official Title
Predictability and Aversive Expectancies in Anxiety and Depressive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2003 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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....
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety Disorder, Psychophysiology, Shock Threat, Context Conditioning, Agoraphobia, Panic Disorder, Generalized Anxiety Disorder, GAD, Healthy Volunteer, HV

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
965 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Threat conditions
Arm Type
Experimental
Arm Description
acoustic startle and shock device
Intervention Type
Device
Intervention Name(s)
Acoustic startle
Intervention Description
Threat condition
Intervention Type
Device
Intervention Name(s)
Electric Shock
Intervention Description
Threat condition
Primary Outcome Measure Information:
Title
Startle Reflex
Description
startle reflex
Time Frame
End of study visit
Title
Performance on cognitive tasks
Description
performance on cognitive tasks
Time Frame
end of study visit
Secondary Outcome Measure Information:
Title
state and trait questionaires
Description
state and trait questionnaires
Time Frame
end of study visit
Title
Skin conductance
Description
skin conductance
Time Frame
end of study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 fluently 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 Employee of NIMH or an immediate family member who is an NIMH employee. Additional exclusion criteria for the active avoidance task Color blindness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Ernst, M.D.
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
.We plan to only share de-identified data in a repository. No identified data will be shared.
IPD Sharing Time Frame
The data will be placed into a repository indefinitely. We plan to start uploading data in the next few months and continue until project completion.
IPD Sharing Access Criteria
Questionnaire and biophysiological data will be shared into the DSP and repository.
Citations:
PubMed Identifier
8018793
Citation
Grillon C, Ameli R, Goddard A, Woods SW, Davis M. Baseline and fear-potentiated startle in panic disorder patients. Biol Psychiatry. 1994 Apr 1;35(7):431-9. doi: 10.1016/0006-3223(94)90040-x.
Results Reference
background
PubMed Identifier
9821567
Citation
Grillon C, Morgan CA 3rd, Davis M, Southwick SM. Effects of experimental context and explicit threat cues on acoustic startle in Vietnam veterans with posttraumatic stress disorder. Biol Psychiatry. 1998 Nov 15;44(10):1027-36. doi: 10.1016/s0006-3223(98)00034-1.
Results Reference
background
PubMed Identifier
10066999
Citation
Grillon C, Morgan CA 3rd. Fear-potentiated startle conditioning to explicit and contextual cues in Gulf War veterans with posttraumatic stress disorder. J Abnorm Psychol. 1999 Feb;108(1):134-42. doi: 10.1037//0021-843x.108.1.134.
Results Reference
background
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2003-M-0093.html
Description
NIH Clinical Center Detailed Web Page

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Expectation of Unpleasant Events in Anxiety Disorders

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