Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms (COAST)

March 3, 2021 updated by: Norman Schmidt, Florida State University

Randomized Control Trial Examining a Brief Anxiety Sensitivity Cognitive Concerns Intervention for Obsessive Compulsive Symptoms

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
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.
Behavioral: Cognitive Anxiety Sensitivity Treatment
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.
Placebo Comparator: Control
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.
Behavioral: Physical Health Education Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety Sensitivity Index-3 (ASI-3)
Time Frame: Month 1 Follow-Up
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).
Month 1 Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dimensional Obsessive Compulsive Scale (DOCS)
Time Frame: Month 1 Follow-Up
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).
Month 1 Follow-Up
Sheehan Disability Scale (SDS)
Time Frame: Month 1 Follow-Up
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).
Month 1 Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amanda M Raines, M.S., Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Raines02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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