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

Primary Purpose

Obesity, Anxiety Sensitivity, Eating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Sensitivity Training
Health Control
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Anxiety Disorders, Depression, Anxiety Sensitivity, Obesity, Eating, Physical Activity, Exercise

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anxiety Sensitivity Training

Health Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dutch Eating Behavior Questionnaire
The Dutch Eating Behavior Questionnaire will be used to assess emotional eating. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). For the current study, the emotional eating subscale (13 items) will be used as a measure of emotional eating. The 13 items of the subscale are summed and divided by 13 to create a mean score with a range from 1-5. Lower scores on this measure indicate better outcomes.
Eating Expectancy Inventory
The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating. The Eating Expectancy Inventory subscale facets: eating helps manage negative affect; eating leads to feeling out of control; and eating alleviates boredom will be used in the current study. Respondents will be asked to rate on a 7-point Likert scale the degree to which they 1 (completely disagree) to 7 (completely agree) to each item. Responses are summed for each subscale. Lower scores on the 18-item eating helps manage negative affect subscale (possible range = 18 - 126), 4-item eating leads to feeling out of control subscale (possible range 4 - 28), and 4-item eating alleviates boredom subscale (possible range 4 - 28) indicate better outcomes.
Food Cravings Questionnaire-State Version
The Food Cravings Questionnaire-State Version is a 15-item self-report measure used to assess the extent to which individuals experience food cravings. Participants are asked to rate on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) for each item. The Food Cravings Questionnaire-State Version assess five subscales each with 3-items including: (1) an intense desire to eat; (2) anticipation of positive reinforcement that may result from eating; (3) anticipation of relief from negative states and feelings as a result of eating; (4) obsessive preoccupation with food or lack of control over eating; and (5) craving as a physiological state. For the current study, the Food Cravings Questionnaire-State Version total score (all items summed) will be used as a measure of food cravings (possible range = 15 - 75) with lower scores indicating better outcomes.
Eating Disorder Diagnostic Scale
The Eating Disorder Diagnostic Scale is a 22-item questionnaire based on the DSM-IV diagnostic criteria for anorexia nervosa, bulimia nervosa, and binge eating disorder. For the current study, item 8 ("How many times per week on average over the past 3 months have you eaten an unusually large amount of food and experienced a loss of control?") will be used to assess binge eating frequency with lower scores indicating better outcomes (possible range = 0 - 14).
Decisional Balance Measure
The Decisional Balance Measure is a 16-item self-report measure that assesses perceived barriers/benefits to engage in exercise, in addition to the motivational and cognitive processes of behavior change for exercise. Items are rated on a 5- point Likert scale ranging from 1 (not important at all) to 5 (extremely important). The measure yields two factors, negative aspects of exercise (Cons: "At the end of the day, I am too exhausted to be physically active"), and positive aspects of exercise (Pros: "Regular exercise would help me have a more positive outlook on life"). Each subscale will be summed with lower scores on the 6-item Cons subscale indicate better outcomes (possible range = 6 -30) and higher scores on the Pros subscale indicate better outcomes (possible range = 10 -50).
Exercise Self-Efficacy
Exercise self-efficacy will be assessed with a 5-item self-report assessment of one's confidence about their ability to engage in physical activity. Items are rated on a 9-point Likert-type scale that ranges from 0 (not at all confident) to 8 (extremely confident). A total score will be created by summing the 5-items with higher scores indicating a better outcome (possible range 0 - 40).
Mood and Anxiety Symptom Questionnaire Short Form
The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items that will be summed with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items that will be summed with lower scores indicating better outcomes (range = 22 - 110).
Anxiety Sensitivity Index-3
The Anxiety Sensitivity Index-3 is an 18-item measured that will be used to assess sensitivity to, and fear of, the potential negative consequences of anxiety-related symptoms and sensations. Items are rated on a 5-point Likert scale, ranging from 0 (Very Little) to 4 (Very Much). Scores will be calculated by summing all items (possible range = 0 -72), with lower scores indicating a better outcome.
Short-Form General Health Survey
The Short-Form General Health Survey is a 20-item questionnaire in which respondents indicate on a Likert scale their health status across five domains: physical functioning, role functioning, social functioning, mental health, and health perceptions. The physical health functioning subscale will be used in the current study and consists of 6 items related to limitations in a variety of physical activities, ranging from strenuous to basic, due to health. Items range from 1 (limited for more than 3 months) to 3 (not limited at all). Items are transformed to a 0 to 100 scale and averaged to create a score for the subscale. Higher scores reflect a better outcome (possible range 0 - 100).
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a 9-item self-report measure of fatigue severity. Individuals are asked to indicate on a 7-point Likert-type scale ranging from 1 (strong disagreement) to 7 (strong agreement) which best fits each statement regarding fatigue within the last week. Items are summed for a total score with lower scores indicating a better outcome (possible range = 7-63).

Secondary Outcome Measures

Full Information

First Posted
April 13, 2019
Last Updated
April 9, 2021
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03917901
Brief Title
Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
Official Title
Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
March 6, 2021 (Actual)
Study Completion Date
March 6, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Anxiety Sensitivity, Eating, Physical Activity
Keywords
Anxiety Disorders, Depression, Anxiety Sensitivity, Obesity, Eating, Physical Activity, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
If participant meets eligibility criteria, the participant will be randomly assigned to complete a one-session computer-delivered intervention: either (1) anxiety sensitivity reduction treatment or (2) health information control.
Masking
Participant
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety Sensitivity Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Anxiety Sensitivity Training
Intervention Description
Computerized Single-Session Anxiety Sensitivity Reduction Program
Intervention Type
Other
Intervention Name(s)
Health Control
Intervention Description
Computerized Single-Session Health Information Control
Primary Outcome Measure Information:
Title
Dutch Eating Behavior Questionnaire
Description
The Dutch Eating Behavior Questionnaire will be used to assess emotional eating. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). For the current study, the emotional eating subscale (13 items) will be used as a measure of emotional eating. The 13 items of the subscale are summed and divided by 13 to create a mean score with a range from 1-5. Lower scores on this measure indicate better outcomes.
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Eating Expectancy Inventory
Description
The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating. The Eating Expectancy Inventory subscale facets: eating helps manage negative affect; eating leads to feeling out of control; and eating alleviates boredom will be used in the current study. Respondents will be asked to rate on a 7-point Likert scale the degree to which they 1 (completely disagree) to 7 (completely agree) to each item. Responses are summed for each subscale. Lower scores on the 18-item eating helps manage negative affect subscale (possible range = 18 - 126), 4-item eating leads to feeling out of control subscale (possible range 4 - 28), and 4-item eating alleviates boredom subscale (possible range 4 - 28) indicate better outcomes.
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Food Cravings Questionnaire-State Version
Description
The Food Cravings Questionnaire-State Version is a 15-item self-report measure used to assess the extent to which individuals experience food cravings. Participants are asked to rate on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) for each item. The Food Cravings Questionnaire-State Version assess five subscales each with 3-items including: (1) an intense desire to eat; (2) anticipation of positive reinforcement that may result from eating; (3) anticipation of relief from negative states and feelings as a result of eating; (4) obsessive preoccupation with food or lack of control over eating; and (5) craving as a physiological state. For the current study, the Food Cravings Questionnaire-State Version total score (all items summed) will be used as a measure of food cravings (possible range = 15 - 75) with lower scores indicating better outcomes.
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Eating Disorder Diagnostic Scale
Description
The Eating Disorder Diagnostic Scale is a 22-item questionnaire based on the DSM-IV diagnostic criteria for anorexia nervosa, bulimia nervosa, and binge eating disorder. For the current study, item 8 ("How many times per week on average over the past 3 months have you eaten an unusually large amount of food and experienced a loss of control?") will be used to assess binge eating frequency with lower scores indicating better outcomes (possible range = 0 - 14).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Decisional Balance Measure
Description
The Decisional Balance Measure is a 16-item self-report measure that assesses perceived barriers/benefits to engage in exercise, in addition to the motivational and cognitive processes of behavior change for exercise. Items are rated on a 5- point Likert scale ranging from 1 (not important at all) to 5 (extremely important). The measure yields two factors, negative aspects of exercise (Cons: "At the end of the day, I am too exhausted to be physically active"), and positive aspects of exercise (Pros: "Regular exercise would help me have a more positive outlook on life"). Each subscale will be summed with lower scores on the 6-item Cons subscale indicate better outcomes (possible range = 6 -30) and higher scores on the Pros subscale indicate better outcomes (possible range = 10 -50).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Exercise Self-Efficacy
Description
Exercise self-efficacy will be assessed with a 5-item self-report assessment of one's confidence about their ability to engage in physical activity. Items are rated on a 9-point Likert-type scale that ranges from 0 (not at all confident) to 8 (extremely confident). A total score will be created by summing the 5-items with higher scores indicating a better outcome (possible range 0 - 40).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Mood and Anxiety Symptom Questionnaire Short Form
Description
The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items that will be summed with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items that will be summed with lower scores indicating better outcomes (range = 22 - 110).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Anxiety Sensitivity Index-3
Description
The Anxiety Sensitivity Index-3 is an 18-item measured that will be used to assess sensitivity to, and fear of, the potential negative consequences of anxiety-related symptoms and sensations. Items are rated on a 5-point Likert scale, ranging from 0 (Very Little) to 4 (Very Much). Scores will be calculated by summing all items (possible range = 0 -72), with lower scores indicating a better outcome.
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Short-Form General Health Survey
Description
The Short-Form General Health Survey is a 20-item questionnaire in which respondents indicate on a Likert scale their health status across five domains: physical functioning, role functioning, social functioning, mental health, and health perceptions. The physical health functioning subscale will be used in the current study and consists of 6 items related to limitations in a variety of physical activities, ranging from strenuous to basic, due to health. Items range from 1 (limited for more than 3 months) to 3 (not limited at all). Items are transformed to a 0 to 100 scale and averaged to create a score for the subscale. Higher scores reflect a better outcome (possible range 0 - 100).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up
Title
Fatigue Severity Scale
Description
The Fatigue Severity Scale (FSS) is a 9-item self-report measure of fatigue severity. Individuals are asked to indicate on a 7-point Likert-type scale ranging from 1 (strong disagreement) to 7 (strong agreement) which best fits each statement regarding fatigue within the last week. Items are summed for a total score with lower scores indicating a better outcome (possible range = 7-63).
Time Frame
Assess change from baseline to 1-week, 2-week and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke Kauffman, MA
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety and Health Research Lab, Substance Use Treatment Clinic, University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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