Addressing Mental Health Needs of Bariatric Surgery Patients who Experience Weight Recurrence with Depression and Anxiety

J
Jill Diane Connors

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

What is the purpose of this study?
The primary goal of this study is to evaluate the feasibility, acceptability, and preliminary effectiveness of an evidence-based, self-help, online cognitive behavioral therapy (CBT) program coupled with peer support for bariatric surgery patients who experience weight recurrence and screen positively for symptoms of depression and anxiety.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be recruited to participate from groups for bariatric patients or patients who are seen for weight recurrence consults in the IU Health Bariatric clinic. Adult patients who had an initial bariatric surgery, either sleeve gastrectomy or RY gastric bypass, will be included. Eligible patients must have gained >10% of their original (nadir) lowest postoperative weight and be at least 24 months out from surgery. 

Detailed description of study

What will happen during the study?

Participation in the intervention will be comprised of four components: 

1) access to a closed Facebook group for patients enrolled in this study who experience weight recurrence; 

2) access to the This Way Up self-help, internet-based CBT course for mixed depression and anxiety; 

3) bi-monthly peer support group virtual meetings; and 

4) bi-monthly follow-up calls from a trained peer leader. 

Upon completion of the 3-month intervention, all participants, if not already an established patient of the IU Bariatric Clinic, will be offered a referral to establish care with one of the bariatric providers or to view 3 healthy lifestyle videos created by the IU Bariatric Clinic. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Depression, Anxiety, Weight Recurrence, Obesity
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
4.1.1    Adult patients who had an initial bariatric surgery (either sleeve gastrectomy or RY gastric bypass) at least 24 months prior to enrollment. 
4.1.2    Patients who have a significant weight recurrence (WR) at least 2 years post-bariatric surgery. Significant WR is defined as a >10% regain from their lowest post-operative weight.
4.1.3    Patients who are at least one year post-surgery and deemed a non-responder by a bariatric clinician
4.1.4    Patients will be pre-screened using the 4-item Patient Health Questionnaire25 for depression and anxiety and must score 3 or greater to be eligible for the study.

Exclusion Criteria
4.2.1    Suicidal thoughts or ideation, for which we will use the last item from the 9-item Patient Health Questionnaire to screen for patients who may be at risk for self-harm.26 
4.3.3.1    Any individuals who screen positively on the 9th item from the PHQ-9 will be further evaluated for suicide risk and referred to a higher level of service as appropriate by the collaborating psychologist.
4.2.2    Any untreated severe mental illness, active psychosis, or current substance abuse. 
4.2.3    Patients who are unable to participate in the online/virtual intervention will also be excluded.
4.2.4    Patients with a BMI ≤ 25

Updated on 22 Apr 2025. Study ID: SURG-IIR-BARIATRIC, 23734
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