Clinical trial NCT05958615: 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
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist Control Design
Primary purpose: SUPPORTIVE_CARE

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).

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

  * Absence of depressive symptoms, relationship challenges, or difficulty coping with lifestyle changes at screening

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline
measure: Depressive Symptoms
timeFrame: Week # 8
measure: Depressive Symptoms
timeFrame: Week #16
Secondary outcomes:
measure: Resilience
timeFrame: Baseline
measure: Resilience
timeFrame: Week # 8
measure: Resilience
timeFrame: Week # 16
measure: Relationship Satisfaction
timeFrame: Baseline
measure: Relationship Satisfaction
timeFrame: Week #8
measure: Relationship Satisfaction
timeFrame: Week #16
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: Week #8
measure: Physical Activity
timeFrame: Week #16
measure: Eating Behaviors
timeFrame: Baseline
measure: Eating Behaviors
timeFrame: Week # 8
measure: Eating Behaviors
timeFrame: Week # 16
measure: Weight Maintenance
timeFrame: Baseline
measure: Weight Maintenance
timeFrame: Week #8
measure: Weight Maintenance
timeFrame: Week #16
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah Craig Neilsen H. Rehabilitation Hospital
name: Larissa McGarrity, PhD
role: PRINCIPAL_INVESTIGATOR
References: