Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners

NCT05958615 | Active Not Recruiting

• 2 other identifiers: IRB_001657371K12TR004413
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this waitlist-control design, pilot randomized controlled trial is to test feasibility, acceptability, and preliminary efficacy of a remotely-delivered dyadic positive psychology intervention for patients 2 years after bariatric surgery and their romantic partners (called ReConnect). The main question it aims to answer is whether the intervention results in improvements in depressive symptoms for patients and partners. The additional questions it aims to answer are whether the intervention results in improvements in resilience, relationship satisfaction, eating and physical activity behaviors, and weight maintenance for those in the intervention versus waitlist control condition. Participant couples randomly assigned to the intervention condition will engage in ReConnect for 8 weekly modules and associated positive psychology activities, some individually and some as a couple. Participant couples randomly assigned to the waitlist control condition will wait for 8 weeks to begin the 8 week intervention. All participants will fill out assessment measures at baseline, 8 weeks, and 16 weeks.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (3)

• Depressive Symptoms

  Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.

  Baseline

• Depressive Symptoms

  Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.

  Week # 8

• Depressive Symptoms

  Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.

  Week #16

Secondary Outcomes (15)

• Resilience

  Baseline

• Resilience

  Week # 8

• Resilience

  Week # 16

• Relationship Satisfaction

  Baseline

• Relationship Satisfaction

  Week #8

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Participants will receive 8 weeks of ReConnect followed by 8 weeks check-in surveys/follow-ups, as well as 3 assessments (baseline, 8 weeks, 16 weeks).

Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect)

Waitlist Control Condition

OTHER

Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks).

Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect)

Interventions

Reimagining Us in the Context of Bariatric Surgery (ReConnect) BEHAVIORAL

ReConnect is an intervention for bariatric surgery patients approximately 2 years after surgery and their romantic partners to participate in together with the goal of improving mental health and enhancing resilience. The intervention is entirely remotely-delivered via handouts sent by PDF and mail to participants instructing them through the 8 weekly modules, as well as associated videos. Each module features psychoeducational materials, instructions and guidance on positive psychology activities, choices of activities to complete both individually and as a couple, and additional resources relevant to that week's theme. The themes are: channeling strengths and focusing on the positive, clarifying values and finding meaning, goal setting, intimacy and fostering the relationship, open communication and gratitude, self-care and savoring the moment, fostering relationships and acts of kindness, and maintaining progress long-term.

Intervention Condition; Waitlist Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult couples (18 years and older) consisting of one partner who had bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) at participating institution
• Between 1 to 3 years post bariatric surgery performed at participating institution and
• A cohabiting romantic partner who have been in the same relationship from before bariatric surgery to time of recruitment
• Both partners are willing and able to enroll in study

You may not qualify if:

• Couples in which both members have undergone bariatric surgery
• Current participation in another intervention study
• Lack of access to internet for remotely delivered intervention
• Absence of depressive symptoms, relationship challenges, or difficulty coping with lifestyle changes at screening

Sponsors & Collaborators

• Larissa McGarrity, Ph.D.: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larissa McGarrity, PhD

  University of Utah Craig Neilsen H. Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Waitlist Control Design

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 24, 2023
• Study Start: February 12, 2024
• Primary Completion: March 19, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)