Objective: This study aims to evaluate the feasibility and effectiveness of the OB-WELL program, an internet-based self-help intervention grounded in the principles of Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST), designed to promote psychological well-being among individuals with obesity from the general Italian population. Methods: A three-arm randomized controlled trial with individual-level random allocation will be conducted to compare two active intervention formats - CBT and BST - with a waiting list (WL) control condition. The intervention will last six weeks and will consist of five online self-help modules followed by one individual synchronous session. Selected psychological outcomes will be assessed at baseline and immediately post-intervention (after 6 weeks). Participants in the experimental groups will also complete follow-up assessments at 3, 6, and 12 months after treatment termination.
Expected results and conclusions: Both active interventions are expected to show greater improvements immediately post-treatment compared to the waitlist (WL) condition, and these effects are anticipated to be maintained over time. It is further hypothesized that the BST condition will demonstrate greater stability of psychological outcomes at follow-up compared to CBT.
Adults aged 18 years or older;
Body Mass Index (BMI) ≥ 30 kg/m²; 3. Internet access;
Sufficient computer and internet literacy;
Fluent knowledge of the Italian language;
Visual, auditory, or cognitive impairments that could limit effective interaction with the digital interface;
Diagnosis of severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
Insufficient digital literacy or lack of stable internet connectivity;
Concurrent psychopharmacological treatment or ongoing psychological/psychotherapeutic intervention during the study period.
Parallel
BST Internet-based intervention
BehavioralParticipants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Brief Strategic Therapy (BST). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.
CBT Internet-based intervention
BehavioralParticipants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Cognitive Behavioral Therapy (CBT). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.
General Psychological Distress
The Clinical Outcomes in Routine Evaluation-10 (CORE-10) (La Tona et al., 2023) is a brief 10-item self-report measure assessing general psychological distress for routine outcome monitoring in clinical and research settings. It is a shortened version of the 34-item CORE-Outcome Measure (CORE-OM) and covers key domains of distress, including psychological problems, functioning, and risk to self. Items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (most or all of the time), yielding a total score ranging from 0 to 40, with higher scores indicating greater psychological distress. Two items are positively worded and are reverse-scored.
Stress
The Perceived Stress Scale (PSS) (Mondo et al., 2021) is a 10-item self-report measure assessing the degree to which individuals perceive situations in their lives as stressful. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). After reversing items 4, 5, 7, and 8, total scores range from 0 to 40, with higher scores reflecting greater perceived stress.
Emotional Regulation
The Difficulties in Emotion Regulation Scale - 8 items (DERS-8) (Rossi et al., 2025) is a brief self-report measure assessing difficulties in emotion regulation. It includes 8 items rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The scale evaluates key aspects of emotional dysregulation, including lack of emotional clarity, difficulties in goal-directed behavior, impulse control difficulties, and limited access to effective emotion regulation strategies. Higher scores indicate greater difficulties in emotion regulation.
Compulsive Eating Behaviors
The Measure of Eating Compulsivity - Italian version (MEC10-IT) (Rossi et al., 2023) is a 10-item self-report questionnaire assessing compulsive eating behaviors within the food addiction framework. Items are rated on a 5-point Likert scale ranging from 0 (very untrue) to 4 (very true), with higher total scores indicating greater levels of eating compulsivity. The Italian version has demonstrated good internal consistency, construct validity, and adequate screening accuracy in both clinical and non-clinical samples.
Anxiety
The Generalized Anxiety Disorder 7-item scale (GAD-7) (Spitzer et al., 2006) is a 7-item self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), yielding a total score between 0 and 21. According to established cut-off scores, values of 5, 10, and 15 indicate mild, moderate, and severe anxiety symptoms, respectively. The GAD-7 has demonstrated excellent reliability and validity and is widely used in both clinical practice and research settings.
Click on the lead sponsor to view all of their trials.
Catholic University of the Sacred Heart
Lead sponsor
Linkoeping University
Collaborator
Istituto Auxologico Italiano
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
