NCT03917901

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

Completed NA Results posted Last updated 26 August 2024

What this trial tests

NA trial testing Anxiety Sensitivity Training in Obesity in 131 participants. Completed in 6 March 2021.

Timeline

16 September 2019

Primary endpoint
6 March 2021

6 March 2021

Quick facts

Lead sponsor	University of Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	131
Start date	16 September 2019
Primary completion	6 March 2021
Estimated completion	6 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Anxiety Sensitivity Training
• Health Control

Conditions studied

• Obesity — all drugs for Obesity →
• Anxiety Sensitivity — all drugs for Anxiety Sensitivity →
• Eating — all drugs for Eating →
• Physical Activity — all drugs for Physical Activity →

Sponsor

University of Houston

Who can join

18 and older, any sex, with Obesity or Anxiety Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anxiety Sensitivity Index-3 Primary · 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.

Baseline

Group	Value	95% CI
Anxiety Sensitivity Training	43.44	± 12.27
Health Control	43.00	± 12.43

1-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	40.17	± 14.03
Health Control	40.69	± 13.15

2-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	38.00	± 15.13
Health Control	37.24	± 14.10

1-Month Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	37.74	± 16.29
Health Control	34.25	± 13.93

Dutch Eating Behavior Questionnaire Primary · 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.

Baseline

Group	Value	95% CI
Anxiety Sensitivity Training	3.58	± 0.91
Health Control	3.68	± 0.87

1-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	3.54	± 1.03
Health Control	3.59	± 0.92

2-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	3.31	± 1.08
Health Control	3.52	± 0.94

1-Month Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	3.21	± 1.15
Health Control	3.35	± 0.98

Eating Expectancy Inventory Primary · 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.

Baseline

Group	Value	95% CI
Anxiety Sensitivity Training	88.17	± 22.11
Health Control	90.06	± 20.69

1-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	85.98	± 25.89
Health Control	89.03	± 23.08

2-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	82.19	± 26.18
Health Control	88.30	± 23.15

1-Month Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	80.74	± 28.71
Health Control	87.51	± 22.59

Exercise Self-Efficacy Primary · 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).

Baseline

Group	Value	95% CI
Anxiety Sensitivity Training	14.11	± 9.31
Health Control	16.59	± 8.13

1-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	16.37	± 9.77
Health Control	18.06	± 8.11

2-Week Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	15.52	± 9.14
Health Control	17.54	± 8.48

1-Month Follow-up

Group	Value	95% CI
Anxiety Sensitivity Training	16.32	± 9.51
Health Control	17.20	± 8.20

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanisms of maladaptive eating behavior among individuals with obesity and pain: exploring rumination.
   Bevers LM, Rogers AH, Zvolensky MJ, Redmond BY. · · 2026 · PMID 42207434 · DOI 10.1007/s10865-026-00680-4