Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity

NCT ID: NCT03917901

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2021-03-06

Brief Summary

The proposed study will design and evaluate a computerized-delivered single-session anxiety sensitivity reduction program (i.e., Anxiety Sensitivity Training; AST). The AST will be designed to achieve three primary aims: (1) provide psycho-educational information on AS and its consequences, (2) present psycho-educational information on the relationship between AS and obesity-related health behavior correlates, and (3) offer concrete, evidence-based strategies to facilitate motivation to change their obesity-related lifestyle behaviors.

Detailed Description

The primary goal of the research study is to investigate the efficacy of a brief, computer-delivered transdiagnostic intervention that addresses anxiety sensitivity to reduce emotional eating, eating expectancies, food cravings, binge eating, perceived barriers to engage in physical activity, anxiety/depressive symptoms, severity of daily fatigue and increase perceived benefits to engage in physical activity, exercise self-efficacy, willingness to use adaptive coping strategies, and perceived physical health functioning. To address this aim, the investigator's will implement a randomized controlled trial that will employ a longitudinal experimental design and involve five stages: (a) online pre-screener; (b) baseline survey consisting of a pre-intervention assessment (eligibility) and random assignment to a one-session computer-delivered intervention (Active versus Control); (c) 1-week follow-up survey; (d) 2-week follow-up survey; (e) 1-month follow-up survey.

Conditions

Obesity; Anxiety Sensitivity; Eating; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anxiety Sensitivity Training

The Anxiety Sensitivity training (AST) will provide: (1) psychoeducation on anxiety sensitivity and its consequences, (2) psychoeducation on the relationship between anxiety sensitivity and obesity-related health behavior correlates, and (3) concrete, evidenced-based strategies to reduce anxiety sensitivity.

Group Type: EXPERIMENTAL

Anxiety Sensitivity Training

Intervention Type: OTHER

Computerized Single-Session Anxiety Sensitivity Reduction Program

Health Control

The Health Control (HC) will cover general health care, such as information on wearing sunscreen and regular attendance to doctor appointments. The HC will not provide any recommendations or education on mood, dietary, or physical habits.

Group Type: PLACEBO_COMPARATOR

Health Control

Intervention Type: OTHER

Computerized Single-Session Health Information Control

Interventions

Anxiety Sensitivity Training

Computerized Single-Session Anxiety Sensitivity Reduction Program

Intervention Type: OTHER

Health Control

Computerized Single-Session Health Information Control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have a body mass index of at least 30
• Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater

Exclusion Criteria

• Any anticipated matters that would interfere with participating in the study
• Not being fluent in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Brooke Kauffman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brooke Kauffman, MA

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Michael J Zvolensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

Anxiety and Health Research Lab, Substance Use Treatment Clinic, University of Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.uh.edu/class/psychology/clinical-psych/research/restore/index

Project Website

Other Identifiers

STUDY00001405

Identifier Type: -

Identifier Source: org_study_id