## Protocol Section
### Identification Module
**NCT ID:** NCT01947179

**Acronym:** CAST

**Brief Title:** Cognitive Anxiety Sensitivity Treatment for Suicide

**Official Title:** Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity

#### Organization Study ID Info
**ID:** 03969
#### Organization
**Class:** OTHER
**Full Name:** Florida State University
### Status Module
#### Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-09-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-01

**Type:** ACTUAL

#### Start Date
**Date:** 2011-09

**Status Verified Date:** 2013-09

#### Study First Post Date
**Date:** 2013-09-20
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-12
**Study First Submit QC Date:** 2013-09-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** United States Department of Defense

#### Lead Sponsor

**Class:** OTHER

**Name:** Florida State University

#### Responsible Party

**Investigator Affiliation:** Florida State University

**Investigator Full Name:** Norman Schmidt

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.

**Detailed Description:** CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment.

### Conditions Module

**Conditions:**

- Anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 108

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Physical Health Training condition will include information on the importance and benefits of a healthy lifestyle. Additionally, the program will discuss guidelines for a healthy lifestyle including information on diet, water consumption, exercise, and sleep.

**Label:** Physical Health Training

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** The anxiety risk reduction intervention will include psychoeducation focused on the nature of stress and its effect on the body. Interoceptive exposure exercises that were designed to correct the conditioned fear of bodily sensations will be explained and practiced.

**Intervention Names:**

- Behavioral: Anxiety Risk Reduction

**Label:** Anxiety Risk Reduction

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Anxiety Risk Reduction

**Description:** Involves psychoeducation and interoceptive exposure exercises

**Name:** Anxiety Risk Reduction

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** The PDS is a self-report measure used to assess the severity of posttraumatic stress symptoms during the past month. The measure was designed based on Diagnostic and Statistical Manual-IV criteria. Respondents report if they have experienced any of 12 traumatic events, including an "other" category, and then indicate which event was the most disturbing. Additionally, respondents rate the frequency of 17 PTSD symptoms experienced in the past month in relation to the most disturbing event they endorsed. The PDS has excellent psychometric properties and can be used as a continuous measure of PTSD symptom severity.

**Measure:** Posttraumatic Diagnostic Scale (PDS)

**Time Frame:** Month one follow-up

#### Primary Outcomes

**Description:** The ASI is a 16-item self-report measure of anxiety sensitivity. Each item consists of a possible negative consequence of anxiety symptoms. The scale assesses three AS subfactors including cognitive, physical, and social concerns. The measure has shown good psychometric properties.

**Measure:** Anxiety Sensitivity Index (ASI)

**Time Frame:** Month one follow-up

#### Secondary Outcomes

**Description:** The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity.

**Measure:** Beck Suicide Scale (BSS)

**Time Frame:** Month one follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At or above the community sample mean on the ASI
* English speakers
* 18 years of age or older

Exclusion Criteria:

* Significant medical illness
* Current substance dependence
* Current or past psychotic-spectrum disorders
* Uncontrolled bipolar disorder
* Serious suicidal intent that warranted immediate medical treatment

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tallahassee

**Country:** United States

**Facility:** Florida State University

**State:** Florida

**Zip:** 32304

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000016728

- Term: Self-Injurious Behavior

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M16191

- Name: Suicide

- Relevance: HIGH

- As Found: Suicide

- ID: M2958

- Name: Suicide Prevention

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000013405

- Term: Suicide

### Misc Info Module

- Version Holder: 2024-05-24
