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NCT Number: NCT05958615

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

Bariatric surgery is the most effective intervention for severe obesity and associated co-morbidities. However, around 2 years after surgery, a substantial proportion of patients struggle with weight regain, psychological complications (e.g., disordered eating, depression), and relationship challenges. To achieve optimal long-term outcomes, a biopsychosocial focus and treatment approach is critical. Existing interventions primarily target weight, occur at the individual patient level, use a risk-based or problem-focused lens, and are inaccessible to the average patient. In contrast, this proposed research will test feasibility, acceptability, and preliminary efficacy of an intervention to improve psychosocial health, occurring at the dyadic (patient and partner) level, using a strengths-based or positive psychology lens, and remotely-delivered for accessibility. This multi-faceted approach is needed to address the high rate of psychiatric disorders and lack of social support among bariatric surgery patients that compromises long-term surgical outcomes. Patients in relationships report inconsistency in support provision from partners, lose less weight than those not in relationships, and are at elevated risk of divorce post-surgery. The investigator(s) research has demonstrated declines in relationship satisfaction from before to after surgery, and associations with elevated levels of binge eating, anxiety, and social stress 2 years after surgery. The investigator(s) has also documented the importance of adaptive coping, social support, and resilience for improved mental health and eating behaviors in this stigmatized population. In combination, existing research supports the need for dyadic-level and strengths-focused intervention to prevent exacerbation of psychological distress and difficulties in long-term weight management.

The investigator and research team have utilized pilot grant funding to adapt an evidence-based dyadic positive psychology intervention (dPPI) for post-bariatric surgery patients and their partners. This intervention was developed in a two-phase, mixed-methods study. The investigator first obtained feedback from 6 patients and partners in focus groups about relationship health following bariatric surgery and intervention needs. The investigators then asked these couples to pilot test 4 adapted intervention modules and obtained quantitative and qualitative feedback, which suggested high satisfaction with and benefit from the intervention modules. This study resulted in a finalized 8-module, remotely-delivered dPPI with content consisting of activities (expressing gratitude, practicing acts of kindness, fostering relationships, focusing on the positive, savoring, working toward goals, meaning finding/values, planning for the future) completed individually and as a couple. The dPPI is now ready for formal testing of feasibility, acceptability, and preliminary efficacy in a pilot randomized clinical trial (RCT).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Depressive Symptoms

    Time frame: Baseline

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

  2. Depressive Symptoms

    Time frame: Week # 8

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

  3. Depressive Symptoms

    Time frame: Week #16

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

Secondary outcomes

  1. Resilience

    Time frame: Baseline

    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  2. Resilience

    Time frame: Week # 8

    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  3. Resilience

    Time frame: Week # 16

    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  4. Relationship Satisfaction

    Time frame: Baseline

    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome.

  5. Relationship Satisfaction

    Time frame: Week #8

    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 (0 = minimum - 151 = maximum), the higher the score the better outcome.

  6. Relationship Satisfaction

    Time frame: Week #16

    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome.

  7. Physical Activity

    Time frame: Baseline

    Godin Leisure Time Physical Activity Questionnaire with higher score indicating more physically active on a continuous scale. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

    The Godin Leisure-Time Exercise Questionnaire assesses weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions of at least 15 minutes duration. A total Leisure Score Index (LSI) is calculated as: (9 × strenuous) + (5 × moderate) + (3 × light) activity episodes per week. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

  8. Physical Activity

    Time frame: Week #8

    Godin Leisure Time Physical Activity Questionnaire with higher score indicating more physically active on a continuous scale. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

    The Godin Leisure-Time Exercise Questionnaire assesses weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions of at least 15 minutes duration. A total Leisure Score Index (LSI) is calculated as: (9 × strenuous) + (5 × moderate) + (3 × light) activity episodes per week. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

  9. Physical Activity

    Time frame: Week #16

    Godin Leisure Time Physical Activity Questionnaire with higher score indicating more physically active on a continuous scale. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

    The Godin Leisure-Time Exercise Questionnaire assesses weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions of at least 15 minutes duration. A total Leisure Score Index (LSI) is calculated as: (9 × strenuous) + (5 × moderate) + (3 × light) activity episodes per week. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity.

  10. Eating Behaviors

    Time frame: Baseline

    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  11. Eating Behaviors

    Time frame: Week # 8

    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  12. Eating Behaviors

    Time frame: Week # 16

    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.

  13. Weight Maintenance

    Time frame: Baseline

    Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared.

  14. Weight Maintenance

    Time frame: Week #8

    Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared, (kg/m²).

  15. Weight Maintenance

    Time frame: Week #16

    Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared.

  16. Anxiety

    Time frame: Baseline

    GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.

  17. Anxiety

    Time frame: 8 Weeks

    GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.

  18. Anxiety

    Time frame: Week #16

    GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.

Sponsors and collaborators

Lead sponsor

Larissa McGarrity, Ph.D.

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Evaluation of Feasibility, Acceptability, and Preliminary Efficacy of a Dyadic Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners: A Pilot Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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