TIDHI Mental Health in IBD Patients Study

Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score

The Generalized Anxiety Disorder Assessment (GAD7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Scores range from 0 to 21, with higher scores indicating greater anxiety. This outcome will compare the mean change in GAD-7 scores from baseline between participants receiving one-on-one therapy and those receiving app-based therapy.

Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score

Improvement is defined as a ≥2-point reduction from baseline in GAD-7 score. The outcome will compare the time (months ) it takes participants in the one-on-one therapy group and the app-based therapy group to reach this level of improvement.

Change in Patient Health Questionnaire-9 (PHQ-9) Score

PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores range from 0 to 27, with higher scores indicating greater depression severity. This outcome will assess the mean difference in PHQ-9 scores between the one-on-one therapy and app-based therapy groups.

Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score

Improvement is defined as a ≥2-point reduction from baseline in PHQ-9 score. This outcome compares the time (months ) it takes for participants in the one-on-one therapy group and the app-based therapy group to reach the improvement threshold.

Proportion of Participants Achieving at Least a 2-Point Reduction in GAD-7 Score

This outcome measures the proportion of participants who experience a reduction of at least 2 points in the GAD-7 (range: 0-21, higher scores = worse anxiety) at 6, 9, and 12 months after beginning the Healing Circuits™ intervention.

Proportion of Participants Achieving at Least a 2-Point Reduction in PHQ-9 Score

6, 9, and 12 months following initiation of Healing Circuits™

Mean Change in 36-Item Short Form Survey (SF-36) Score Between Groups

This outcome measures the mean difference in scores on the SF-36, a 36-item, patient-reported survey of patient health. Each item is scored out of 100 and a higher score is correlated to more favorable health. It addresses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The comparison will be made between the one-on-one therapy group and the app-based therapy group at the specified time points.

Mean Change in Patient Satisfaction Score on a Likert Scale Between Groups

This outcome measures the mean difference in patient satisfaction between the one-on-one therapy group and the app-based therapy group. Satisfaction is assessed using a custom 10-point Likert scale ranging from 1 (Worst Possible Experience) to 10 (Best Possible Experience), with higher scores indicating greater satisfaction.