Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171711
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-12-05
Brief Title:
Exposure Therapy Study In Adults With Eating Disorders
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Exposure Therapy for Anorexia Nervosa Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current proposal will evaluate the feasibility acceptability and preliminary efficacy of Exposure Therapy for anorexia nervosa AN spectrum disorders Exp-AN an innovative treatment rooted in principles of inhibitory learning Exp-AN will target anxiety about both eating and weight gain by combining in vivo ie in real life and imaginal ie mental exposure in novel ways eg eating a feared food while listening to a recording describing fears about weight gain
Detailed Description:
The current proposal will evaluate the feasibility acceptability and preliminary efficacy of Exposure Therapy for anorexia nervosa AN Spectrum Disorders Exp-AN an innovative treatment rooted in principles of inhibitory learning Exp-AN will target anxiety about both eating and weight gain by combining in vivo ie in real life and imaginal ie mental exposure in novel ways eg eating a feared food while listening to a recording describing fears about weight gain
The central hypothesis is that Exp-AN will effectively target anxiety related to eating and weight gain via inhibitory learning and improve treatment outcomes The investigator will test two aims
Aim 1 Evaluate the feasibility acceptability and preliminary efficacy of Exp-AN
Hypothesis 11 Exp-AN will be feasible with satisfactory levels of recruitment 50 and retention 70
Hypothesis 12 Participants will engage in Exp-AN as measured by completion of the five treatment modules 80 and therapy homework 60
Hypothesis 13 Participants will rate all five Exp-AN modules as acceptable
Hypothesis 14 Exp-AN will result in increases in BMI and decreases in AN symptomatology
Aim 2 Investigate Exp-ANs mechanisms of action and if mechanisms are associated with positive outcomes
Hypothesis 21 Exp-AN will result in decreases in anxiety between sessions decreases in anxious beliefs and increases in anxiety tolerance
Hypothesis 22 Changes in anxiety ratings anxious beliefs and tolerance of anxiety will be associated with weight gain and reduced AN symptomatology
The central hypothesis is that Exp-AN will effectively target anxiety related to eating and weight gain via inhibitory learning and improve treatment outcomes The investigator will test two aims
Aim 1 Evaluate the feasibility acceptability and preliminary efficacy of Exp-AN
Hypothesis 11 Exp-AN will be feasible with satisfactory levels of recruitment 50 and retention 70
Hypothesis 12 Participants will engage in Exp-AN as measured by completion of the five treatment modules 80 and therapy homework 60
Hypothesis 13 Participants will rate all five Exp-AN modules as acceptable
Hypothesis 14 Exp-AN will result in increases in BMI and decreases in AN symptomatology
Aim 2 Investigate Exp-ANs mechanisms of action and if mechanisms are associated with positive outcomes
Hypothesis 21 Exp-AN will result in decreases in anxiety between sessions decreases in anxious beliefs and increases in anxiety tolerance
Hypothesis 22 Changes in anxiety ratings anxious beliefs and tolerance of anxiety will be associated with weight gain and reduced AN symptomatology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None