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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05958615
Enrollment
82
Registered
2023-07-24
Start date
2024-02-12
Completion date
2026-11-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

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).

Interventions

BEHAVIORALReimagining Us in the Context of Bariatric Surgery (ReConnect)

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.

Sponsors

Larissa McGarrity, Ph.D.
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Waitlist Control Design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
ResilienceBaselineConnor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Relationship SatisfactionBaselineDyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome.
Physical ActivityBaselineGodin 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.
Eating BehaviorsBaselineShort Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Weight MaintenanceBaselineBody Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared.
AnxietyBaselineGAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLarissa McGarrity, PhD

University of Utah Craig Neilsen H. Rehabilitation Hospital

Participant flow

Recruitment details

Patients who had bariatric surgery approximately 2 years prior were recruited from the University of Utah Comprehensive Weight Management Program if they were in the same romantic relationship as prior to surgery. This is a waitlist-control design.

Pre-assignment details

Patients and partners who were interested in participating in the study after contact by the study coordinator completed screening questions by phone, followed by the baseline assessment if they qualified, followed by waitlist control design randomization of the dyad couples to either the intervention or waitlist control condition.

Baseline characteristics

Characteristic
Age, Continuous
Partner
45.7 years
STANDARD_DEVIATION 10.1
Age, Continuous
Patient
43.6 years
STANDARD_DEVIATION 8.9
Race/Ethnicity, Customized
Partner
American Indian/Alaska Native
0 Participants
Race/Ethnicity, Customized
Partner
Asian
0 Participants
Race/Ethnicity, Customized
Partner
Black/African American
1 Participants
Race/Ethnicity, Customized
Partner
Chose Not to Answer
1 Participants
Race/Ethnicity, Customized
Partner
Hispanic/Latino/X
6 Participants
Race/Ethnicity, Customized
Partner
Mixed Race
2 Participants
Race/Ethnicity, Customized
Partner
Native Hawaiian or Pacific Islander
0 Participants
Race/Ethnicity, Customized
Partner
White/Caucasian
29 Participants
Race/Ethnicity, Customized
Patient
American Indian/Alaska Native
0 Participants
Race/Ethnicity, Customized
Patient
Asian
0 Participants
Race/Ethnicity, Customized
Patient
Black/African American
1 Participants
Race/Ethnicity, Customized
Patient
Chose Not to Answer
0 Participants
Race/Ethnicity, Customized
Patient
Hispanic/Latino/X
7 Participants
Race/Ethnicity, Customized
Patient
Mixed Race
1 Participants
Race/Ethnicity, Customized
Patient
Native Hawaiian or Pacific Islander
1 Participants
Race/Ethnicity, Customized
Patient
White/Caucasian
10 Participants
Sex: Female, Male
Partner
Female
4 Participants
Sex: Female, Male
Partner
Male
17 Participants
Sex: Female, Male
Patient
Female
17 Participants
Sex: Female, Male
Patient
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 40
other
Total, other adverse events
0 / 420 / 40
serious
Total, serious adverse events
0 / 420 / 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026