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Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms (COAST)

Primary Purpose

Obsessive-Compulsive Disorder and Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Anxiety Sensitivity Treatment
Physical Health Education Training
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder and Symptoms focused on measuring Obsessive-compulsive disorder, OCD, Anxiety sensitivity, Cognitive Concerns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be 18 years of age or older
  • Elevated levels of obsessive-compulsive symptoms as indicated by scoring one standard deviation above the non-clinical mean on any Dimensional Obsessive-Compulsive Scale dimension
  • Elevated anxiety sensitivity cognitive concerns as indicated by scoring one standard deviation above the non-clinical mean

Exclusion Criteria:

  • Evidence of a significant medical illness that would prevent the completion of interoceptive exposure (IE) exercises
  • Non-English speakers
  • Individuals currently receiving cognitive-behavioral therapy for anxiety and/or mood disorders or who are not stable on psychotropic medications (i.e., new medication or changes in dosage within the last three months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Active

    Control

    Arm Description

    Cognitive Anxiety Sensitivity Treatment (CAST) is a computerized treatment designed to model the educational and behavioral techniques used in anxiety treatments. The psychoeducational component focuses on the nature of stress and its effects on the mind and body. CAST was designed to dispel myths concerning the immediate dangers of stress on cognitive processes. Individuals are taught that psychological arousal from stress is not dangerous and that they may have developed a conditioned fear to these sensations, as indicated by their elevated levels of AS cognitive concerns. In addition to psychoeducation, interoceptive exposure exercises will be introduced to correct the conditioned fear response. The program will demonstrate exercises that elicit sensations consistent with AS cognitive concerns.

    The Physical Health Education Training (PHET) control condition was designed to control for the effects of general education provided in the CAST condition. Participants will be presented with information regarding the importance and benefits of maintaining a healthy lifestyle. The program will discuss diet, alcohol and water consumption, exercise, sexual health, and sleep. PHET will instruct the participant how to monitor their daily health habits in order to achieve a healthy lifestyle. PHET will take approximately 45 minutes to complete. Based on the findings of Schmidt and colleagues (in press), this intervention does not appear to exert a strong effect on AS.

    Outcomes

    Primary Outcome Measures

    Anxiety Sensitivity Index-3 (ASI-3)
    The ASI-3 is an 18-item self-report measure of AS. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. The measure has shown good psychometric properties (Taylor et al., 2007).

    Secondary Outcome Measures

    Dimensional Obsessive Compulsive Scale (DOCS)
    The DOCS is a 20-item measure that assesses the four dimensions of OC symptoms most reliably replicated in previous structural research. This measure includes four subscales: contamination, responsibility, unacceptable thoughts, and symmetry. The DOCS demonstrates excellent psychometric properties and has been validated in both clinical and non-clinical samples (Abramowitz et al., 2010).
    Sheehan Disability Scale (SDS)
    The SDS is a 3-item self-report measure designed to assess functional impairment in work/school, social, and family life. The measure has shown good psychometric properties (Sheehan et al., 1996).

    Full Information

    First Posted
    December 16, 2015
    Last Updated
    March 3, 2021
    Sponsor
    Florida State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02635178
    Brief Title
    Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms
    Acronym
    COAST
    Official Title
    Randomized Control Trial Examining a Brief Anxiety Sensitivity Cognitive Concerns Intervention for Obsessive Compulsive Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Florida State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the population. Whereas several first-line treatments have been established (e.g., pharmacological and psychological), a substantial proportion of patients (40-60%) fail to experience symptom remission, underscoring the need for research in this area. One approach to increasing treatment efficacy is to target underlying risk factors or dysfunctions that may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., "It scares me when I am unable to keep my mind on a task"). There is recent evidence that AS cognitive concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains. However, questions remain as to whether reductions in AS cognitive concerns will lead to subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate the efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder and Symptoms
    Keywords
    Obsessive-compulsive disorder, OCD, Anxiety sensitivity, Cognitive Concerns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active
    Arm Type
    Experimental
    Arm Description
    Cognitive Anxiety Sensitivity Treatment (CAST) is a computerized treatment designed to model the educational and behavioral techniques used in anxiety treatments. The psychoeducational component focuses on the nature of stress and its effects on the mind and body. CAST was designed to dispel myths concerning the immediate dangers of stress on cognitive processes. Individuals are taught that psychological arousal from stress is not dangerous and that they may have developed a conditioned fear to these sensations, as indicated by their elevated levels of AS cognitive concerns. In addition to psychoeducation, interoceptive exposure exercises will be introduced to correct the conditioned fear response. The program will demonstrate exercises that elicit sensations consistent with AS cognitive concerns.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    The Physical Health Education Training (PHET) control condition was designed to control for the effects of general education provided in the CAST condition. Participants will be presented with information regarding the importance and benefits of maintaining a healthy lifestyle. The program will discuss diet, alcohol and water consumption, exercise, sexual health, and sleep. PHET will instruct the participant how to monitor their daily health habits in order to achieve a healthy lifestyle. PHET will take approximately 45 minutes to complete. Based on the findings of Schmidt and colleagues (in press), this intervention does not appear to exert a strong effect on AS.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Anxiety Sensitivity Treatment
    Intervention Description
    Cognitive Anxiety Sensitivity Treatment (CAST) is a computerized treatment designed to model the educational and behavioral techniques used in anxiety treatments. The psychoeducational component focuses on the nature of stress and its effects on the mind and body. CAST was designed to dispel myths concerning the immediate dangers of stress on cognitive processes. Individuals are taught that psychological arousal from stress is not dangerous and that they may have developed a conditioned fear to these sensations, as indicated by their elevated levels of AS cognitive concerns. In addition to psychoeducation, interoceptive exposure exercises will be introduced to correct the conditioned fear response. The program will demonstrate exercises that elicit sensations consistent with AS cognitive concerns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Health Education Training
    Intervention Description
    The Physical Health Education Training (PHET) control condition was designed to control for the effects of general education provided in the CAST condition. Participants will be presented with information regarding the importance and benefits of maintaining a healthy lifestyle. The program will discuss diet, alcohol and water consumption, exercise, sexual health, and sleep. PHET will instruct the participant how to monitor their daily health habits in order to achieve a healthy lifestyle. PHET will take approximately 45 minutes to complete. Based on the findings of Schmidt and colleagues (in press), this intervention does not appear to exert a strong effect on AS.
    Primary Outcome Measure Information:
    Title
    Anxiety Sensitivity Index-3 (ASI-3)
    Description
    The ASI-3 is an 18-item self-report measure of AS. This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. The measure has shown good psychometric properties (Taylor et al., 2007).
    Time Frame
    Month 1 Follow-Up
    Secondary Outcome Measure Information:
    Title
    Dimensional Obsessive Compulsive Scale (DOCS)
    Description
    The DOCS is a 20-item measure that assesses the four dimensions of OC symptoms most reliably replicated in previous structural research. This measure includes four subscales: contamination, responsibility, unacceptable thoughts, and symmetry. The DOCS demonstrates excellent psychometric properties and has been validated in both clinical and non-clinical samples (Abramowitz et al., 2010).
    Time Frame
    Month 1 Follow-Up
    Title
    Sheehan Disability Scale (SDS)
    Description
    The SDS is a 3-item self-report measure designed to assess functional impairment in work/school, social, and family life. The measure has shown good psychometric properties (Sheehan et al., 1996).
    Time Frame
    Month 1 Follow-Up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants must be 18 years of age or older Elevated levels of obsessive-compulsive symptoms as indicated by scoring one standard deviation above the non-clinical mean on any Dimensional Obsessive-Compulsive Scale dimension Elevated anxiety sensitivity cognitive concerns as indicated by scoring one standard deviation above the non-clinical mean Exclusion Criteria: Evidence of a significant medical illness that would prevent the completion of interoceptive exposure (IE) exercises Non-English speakers Individuals currently receiving cognitive-behavioral therapy for anxiety and/or mood disorders or who are not stable on psychotropic medications (i.e., new medication or changes in dosage within the last three months)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amanda M Raines, M.S.
    Organizational Affiliation
    Florida State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Members of the scientific community can request a copy of the data by contacting the PI, Amanda Raines. They should state their reason for request and plans for analyzing. A limit dataset would be created, encrypted, and sent.

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    Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms

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