Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms
COAST
Randomized Control Trial Examining a Brief Anxiety Sensitivity Cognitive Concerns Intervention for Obsessive Compulsive Symptoms
1 other identifier
interventional
72
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMarch 5, 2021
March 1, 2021
2.7 years
December 16, 2015
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Month 1 Follow-Up
Secondary Outcomes (2)
Dimensional Obsessive Compulsive Scale (DOCS)
Month 1 Follow-Up
Sheehan Disability Scale (SDS)
Month 1 Follow-Up
Study Arms (2)
Active
EXPERIMENTALCognitive 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.
Control
PLACEBO COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda M Raines, M.S.
Florida State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 18, 2015
Study Start
August 1, 2014
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
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.