ObesityNCT03917901
Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
A study testing Anxiety Sensitivity Training in people with Obesity and Anxiety Sensitivity, run by University of Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Anxiety Sensitivity, Eating
- What is being tested?
- Anxiety Sensitivity Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 6 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body mass index of at least 30
- Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater
Who cannot join
- Any anticipated matters that would interfere with participating in the study
- Not being fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Health Research Lab, Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204
About this study
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.
Read the 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
- Being tested
- Anxiety Sensitivity Training, Health Control
- Keywords
- Anxiety Disorders, Depression, Anxiety Sensitivity, Obesity, Eating, Physical Activity, Exercise
- Medical subject headings
- Obesity, Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Sensitivity TrainingOther
Computerized Single-Session Anxiety Sensitivity Reduction Program
Health ControlOther
Computerized Single-Session Health Information Control
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Sensitivity Training | Experimental | 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. Receives: Other: Anxiety Sensitivity Training |
| Health Control | Placebo comparator | 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. Receives: Other: Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,1-week, 2-week and 1-month follow-up
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.
Measured: Baseline,1-week, 2-week and 1-month follow-up
Eating Expectancy Inventory
The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating. The Eating Expectancy Inventory subscale facet: eating helps manage negative affect 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) indicate better outcomes.
Measured: Baseline,1-week, 2-week and 1-month follow-up
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).
Measured: Baseline,1-week, 2-week and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start16 Sep 2019
- Primary completion6 Mar 2021
- Study completion6 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brooke Kauffman, University of Houston
- Investigators
- Brooke Kauffman, MA, Principal investigator, University of HoustonMichael J Zvolensky, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917901
- Sponsor's protocol ID
- STUDY00001405
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2019
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bevers LM, Rogers AH, Zvolensky MJ, Redmond BY. Mechanisms of maladaptive eating behavior among individuals with obesity and pain: exploring rumination. J Behav Med. 2026 Aug;49(4):695-705. doi: 10.1007/s10865-026-00680-4. Epub 2026 May 28.
PubMed 42207434
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT03917901
- Acronym / sponsor ID
- STUDY00001405
- Conditions
- Obesity, Anxiety Sensitivity, Eating, Physical Activity
- Keywords
- Anxiety Disorders, Depression, Anxiety Sensitivity, Obesity, Eating, Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 6 Mar 2021 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anxiety Sensitivity Training | Experimental | Other: Anxiety Sensitivity TrainingThe 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. |
| Health Control | Placebo comparator | Other: Health ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a body mass index of at least 30
- Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater
Key exclusion criteria (2 listed)
- Any anticipated matters that would interfere with participating in the study
- Not being fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety Sensitivity TrainingComputerized Single-Session Anxiety Sensitivity Reduction Program | Other | Anxiety Sensitivity Training |
| Health ControlComputerized Single-Session Health Information Control | Other | Health Control |
Primary outcome
Anxiety Sensitivity Index-3
Time frame: Baseline,1-week, 2-week and 1-month follow-up
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.
Dutch Eating Behavior Questionnaire
Time frame: Baseline,1-week, 2-week and 1-month follow-up
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
Time frame: Baseline,1-week, 2-week and 1-month follow-up
The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating. The Eating Expectancy Inventory subscale facet: eating helps manage negative affect 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) indicate better outcomes.
Exercise Self-Efficacy
Time frame: Baseline,1-week, 2-week and 1-month follow-up
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42207434Bevers LM, Rogers AH, Zvolensky MJ, Redmond BY. Mechanisms of maladaptive eating behavior among individuals with obesity and pain: exploring rumination. J Behav Med. 2026 Aug;49(4):695-705. doi: 10.1007/s10865-026-00680-4. Epub 2026 May 28.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Kauffman, MA principal investigator
University of Houston
Michael J Zvolensky, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Sensitivity Training in people with Obesity and Anxiety Sensitivity, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Sensitivity Index-3 (time frame: Baseline,1-week, 2-week and 1-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.