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

Primary Purpose

Obesity, Morbid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reimagining Us in the Context of Bariatric Surgery (ReConnect)
Sponsored by
Larissa McGarrity, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity, Morbid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention Condition

    Waitlist Control Condition

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Resilience
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Resilience
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Resilience
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Relationship Satisfaction
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Relationship Satisfaction
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Relationship Satisfaction
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Physical Activity
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Physical Activity
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Physical Activity
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Eating Behaviors
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Eating Behaviors
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Eating Behaviors
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Weight Maintenance
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.
    Weight Maintenance
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.
    Weight Maintenance
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Larissa McGarrity, Ph.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05958615
    Brief Title
    Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Larissa McGarrity, Ph.D.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Waitlist Control Design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Condition
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Waitlist Control Condition
    Arm Type
    Other
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reimagining Us in the Context of Bariatric Surgery (ReConnect)
    Intervention Description
    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 Outcome Measure Information:
    Title
    Depressive Symptoms
    Description
    Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.
    Time Frame
    Baseline
    Title
    Depressive Symptoms
    Description
    Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.
    Time Frame
    Week # 8
    Title
    Depressive Symptoms
    Description
    Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse outcome.
    Time Frame
    Week #16
    Secondary Outcome Measure Information:
    Title
    Resilience
    Description
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Baseline
    Title
    Resilience
    Description
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Week # 8
    Title
    Resilience
    Description
    Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Week # 16
    Title
    Relationship Satisfaction
    Description
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Time Frame
    Baseline
    Title
    Relationship Satisfaction
    Description
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Time Frame
    Week #8
    Title
    Relationship Satisfaction
    Description
    Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    Time Frame
    Week #16
    Title
    Physical Activity
    Description
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Time Frame
    Baseline
    Title
    Physical Activity
    Description
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Time Frame
    Week #8
    Title
    Physical Activity
    Description
    Leisure Time Physical Activity Questionnaire is an assessment change from initial baseline measure.
    Time Frame
    Week #16
    Title
    Eating Behaviors
    Description
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Baseline
    Title
    Eating Behaviors
    Description
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Week # 8
    Title
    Eating Behaviors
    Description
    Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
    Time Frame
    Week # 16
    Title
    Weight Maintenance
    Description
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.
    Time Frame
    Baseline
    Title
    Weight Maintenance
    Description
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.
    Time Frame
    Week #8
    Title
    Weight Maintenance
    Description
    Percent Excess Weight Loss. Change will be assessed from initial reported weight.
    Time Frame
    Week #16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heidi Hansen, BS
    Phone
    80-585-2373
    Email
    heidi.hansen@hsc.utah.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Larissa McGarrity, PhD
    Organizational Affiliation
    University of Utah Craig Neilsen H. Rehabilitation Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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