Comparison of a Telehealth Versus In-person Intervention for Binge Eating

Binge Eating Clinical Trial

Official title:

Comparison of a Telehealth Versus In-person Intervention for Binge Eating Among Adults and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725408
• Other study ID #: IRB2022-0163D
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: January 2023
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adults and adolescents will be asked to participate in a 10-week intervention to better understand their emotions and improve their relationship with food.

Description:

Adults and adolescents will be asked to participate in a 10-week eating intervention to better understand and manage their emotions and improve their relationship with food. Participants will fill out questionnaires related to their engagement in body avoidance behaviors and disordered eating, and assess their self-reported levels of impulsivity, food insecurity, mindfulness skills, emotion regulation skills, and distress tolerance skills. Participants will also be asked questions to assess the feasibility and acceptability of the telehealth format.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria for Adolescent Group:

• Adolescent in high school (ages ~13-18)
• Participant and their caregiver must be able to understand and speak English
• Has access to a computer device or tablet with a microphone and web camera
• Has access to a reliable internet connection and a private, quiet place to complete sessions
• Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group
• Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances

Exclusion Criteria for Adolescent Group:

• Active suicidal ideation within the past 2 weeks
• Has been diagnosed with an intellectual disability
• Active psychosis or experiencing psychosis symptoms
• Caregiver is not able to participate

Inclusion for Adult Group:

• Age 18+
• Speaks and understands English
• Has access to a computer device or tablet with a microphone and web camera
• Has access to a reliable internet connection and a private, quiet place to complete sessions
• Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group
• Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances

Exclusion Criteria for Adult Group:

• Active suicidal ideation within the past 2 weeks
• Has been diagnosed with an intellectual disability
• Active psychosis or experiencing psychosis symptoms

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia

Intervention

Behavioral:
• Dialectical behavior therapy-informed group eating intervention protocol (telehealth)
A 10-week, skills-based group eating intervention. Online/telehealth meetings will last approximately 1 hour each session, besides the first session (1.5 hours, orientation and assessments) and the final session (approx. 2-2.5 hours, session plus final assessments and exit interview).
• Dialectical behavior therapy-informed group eating intervention protocol (in-person)
A 10-week, skills-based group eating intervention. In-person meetings will last approximately 1 hour each session, besides the first session (1.5 hours, orientation and assessments, online) and the final session (approx. 2-2.5 hours, session plus final assessments and exit interview).

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Texas A&M University	Academy for Eating Disorders, American Psychological Foundation, Psi Chi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in binge eating	Episodes and frequency of binge eating and binge eating behaviors via the Eating Disorder Examination Questionnaire. Two items from this scale will be used to assess for the number of episodes and frequency of binge eating. Participants are asked to respond with numeric values to these items according to their subjective view (e.g., may write "8" to to represent eight episodes of binge eating over the past 28 days). Partcipants provide a numeric response from 0+ (no maximum number). Higher scores indicate more episodes of binge eating.	Participants will be asked to complete a measure of binge eating at baseline and immediately after the last session of the intervention (Week 10) to assess change in binge eating behaviors.
Primary	Feasibility of attending and engaging in a binge eating intervention.	Participants will be asked open-ended questions in an interview format about the feasibility of attending and engaging in a binge eating intervention (telehealth or in-person). For example, one of the items asks, "Were there too many sessions or just enough?"	Participants will be asked these questions via a brief exit interview immediately after the last session of the intervention (Week 10) to assess intervention feasibility.
Primary	Satisfaction with the binge eating intervention	Participants will be asked nine questions developed by the author and collaborators about how acceptable they found the intervention (telehealth or in-person) to be (e.g., "I would recommend this program to a friend or family member who has difficulty with binge eating"). Six of the questions can be answered with either "Yes", "No", or "Don't know." The remaining three items are open-ended.	Participants will be asked questions immediately after the last session of the intervention (Week 10).
Secondary	Change in body image avoidance	Engagement in body image avoidance behaviors (e.g., actively refraining from looking in the mirror) assessed via the Body Image Avoidance Questionnaire. Participants can respond according to a Likert scale of 1 (Rarely or Never) through 5 (Always). The total score can range from 0 to 95. Higher scores indicate greater body image avoidance.	Participants will be asked to complete the Body Image Avoidance Questionnaire weekly to assess changes in body image avoidance throughout the intervention (at baseline/pre-intervention and every week at the beginning of the session, weeks 2-10).
Secondary	Change in appearance overvaluation	The extent to which participants place large value on their appearance assessed via the Beliefs About Appearance Scale. Participants can respond according to a Likert scale of 0 (Not at all) to 4 (Extremely). Higher scores indicate greater appearance overvaluation.	Participants will be asked to complete the Beliefs About Appearance Scale weekly to assess change in appearance overvaluation throughout the intervention (at baseline and every week at the beginning of the session, weeks 2-10).
Secondary	Change in disordered eating (other than binge eating)	Engagement in behaviors representative of disordered eating (e.g., restriction of diet, excessive exercise, etc.) assessed via the Eating Disorder Examination Questionnaire. Most of the questions are answered by responding to a 7-point Likert scale ranging from 0 (No days) to 6 (Every day). Other items require a response in a numeric value provided by the participant (e.g., "6" for "6 days"). Other items require a response using a 7-point Likert scale ranging from 1 (Not at all) to 6 (Markedly). Participants who identify as "female" are also asked an additional question where they can either mark "yes" or "no." In all cases, positive or higher scores indicate greater engagement in disordered eating.	Participants will be asked to complete a measure of disordered eating at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Secondary	Change in impulsivity	Engagement in impulsive behaviors (e.g., sensation-seeking) assessed via the UPPS-P Impulsive Behavior Scale (UPPS-P = urgency, premeditation, perseverance, sensation seeking, and positive urgency...it is not usually spelled out). Participants are asked to respond using a 4-point Likert scale ranging from 0 (Agree strongly) to 3 (Disagree strongly). Higher scores indicate higher levels of impulsivity.	Participants will be asked to complete a measure of impulsivity at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Secondary	Change in mindfulness skills	Current engagement in mindful activities or practices assessed via the Kentucky Inventory of Mindfulness Skills. Participants are asked to respond using a 5-point Likert scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Higher scores indicate more, or greater, use of mindfulness skills.	Participants will be asked to complete a measure of mindfulness at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Secondary	Change in emotion regulation	Ability to regulate or suppress emotions or engage in cognitive reappraisal are assessed via the Emotion Regulation Questionnaire (ERQ). Participants are asked to respond according to a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater use of cognitive reappraisal and emotional suppression.	Participants will be asked to complete a measure of emotion regulation at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Secondary	Change in distress tolerance	Ability to tolerate distress assessed via the Distress Tolerance Scale (DTS). Participants are asked to respond according to a 5-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate greater, or higher, distress tolerance.	Participants will be asked to complete a measure of distress tolerance at baseline and post-intervention (during the final group session).
Secondary	Food insecurity	Level of food insecurity assessed via the United States Household Food Security Survey Module: Six-item Short Form. Items are multiple choice (e.g., "often true", "sometimes true", "never true", or "don't know or refuse to answer"). Scores are coded and then scored such that higher scores indicate greater, or higher, food insecurity. Scores can range from 0 to 6.	Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
Secondary	Change in binge eating disorder status	The Questionnaire on Weight and Eating Patterns, Revised, Diagnostic and Statistical Manual of Mental Disorders Version 5 (QEWP-5) will be used to assess and diagnose individuals with binge eating disorder. Items are assessed using multiple choice and open-ended questions. Scores are summed together to determine whether the criteria for binge eating disorder are met.	Participants will be asked to complete a diagnostic measure of binge eating disorder at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).