The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity

NCT07476599 | Not Yet Recruiting

• 1 other identifier: 03C101
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity (BMI > 35)

Keywords

Internet-based interventions; Obesity; Mental health; Cognitive Behavioral Therapy; Brief Strategic Therapy; Randomized controlled trial; Clinical psychology

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

Secondary Outcomes (8)

• Stress

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

• Emotional Regulation

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

• Compulsive Eating Behaviors

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

• Anxiety

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

• Depression

  baseline, post-intervention (6 weeks), 3-, 6-, 12-month follow-up

Study Arms (3)

CBT intervention

EXPERIMENTAL

Participants allocated to the CBT experimental group will be asked to complete one module per week (6 weeks), each based on the core principles of Cognitive Behavioral Therapy (CBT). The modules are 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.

Behavioral: CBT Internet-based intervention

BST intervention

EXPERIMENTAL

Participants allocated to the CBT experimental group will be asked to complete one module per week (6 weeks), each based on the core principles of Brief Strategic Therapy (BST). The modules are 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.

Behavioral: BST Internet-based intervention

Waiting List

NO INTERVENTION

Participants allocated to the waiting list control group will not receive the intervention during the initial six-week study period. However, they will be granted full access to the treatment program after the six weeks have elapsed.

Interventions

BST Internet-based intervention BEHAVIORAL

Participants 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.

BST intervention

CBT Internet-based intervention BEHAVIORAL

Participants 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.

CBT intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Provision of informed consent via the digital platform;
• Presence of mild or subthreshold psychological or eating-related symptoms, as identified by the Web Screening Questionnaire (WSQ);
• Presence of a score \< 27 on the Binge Eating Scale (BES).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: collaborator
• Catholic University of the Sacred Heart: lead
• Linkoeping University: collaborator

Study Sites (1)

Catholic University of Sacred Heart

Milan, Italy, Italy

Location

Related Publications (5)

• Bertuzzi V, Semonella M, Andersson G, Manzoni GM, Castelnuovo G, Molinari E, Pietrabissa G. Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project. Trials. 2022 Sep 24;23(1):801. doi: 10.1186/s13063-022-06714-x.

  PMID: 36153586 BACKGROUND

• Pietrabissa G, Castelnuovo G, Jackson JB, Rossi A, Manzoni GM, Gibson P. Brief Strategic Therapy for Bulimia Nervosa and Binge Eating Disorder: A Clinical and Research Protocol. Front Psychol. 2019 Mar 8;10:373. doi: 10.3389/fpsyg.2019.00373. eCollection 2019.

  PMID: 30906269 BACKGROUND

• Lautenbach A, Bluher M, Mijuskovic A, Jones L, Schirmann F. Efficacy of a digital health application for weight management in people with obesity: 6-months results from a randomized controlled trial. Int J Obes (Lond). 2026 Feb;50(2):466-473. doi: 10.1038/s41366-025-01967-3. Epub 2025 Dec 17.

  PMID: 41408456 BACKGROUND

• Jackson JB, Pietrabissa G, Rossi A, Manzoni GM, Castelnuovo G. Brief strategic therapy and cognitive behavioral therapy for women with binge eating disorder and comorbid obesity: A randomized clinical trial one-year follow-up. J Consult Clin Psychol. 2018 Aug;86(8):688-701. doi: 10.1037/ccp0000313.

  PMID: 30035585 BACKGROUND

• Hartmann-Boyce J, Theodoulou A, Oke JL, Butler AR, Scarborough P, Bastounis A, Dunnigan A, Byadya R, Hobbs FDR, Sniehotta FF, Jebb SA, Aveyard P. Association between characteristics of behavioural weight loss programmes and weight change after programme end: systematic review and meta-analysis. BMJ. 2021 Aug 17;374:n1840. doi: 10.1136/bmj.n1840.

  PMID: 34404631 BACKGROUND

MeSH Terms

Conditions

Obesity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Gianluca Castelnuovo

  Catholic University of Sacred Heart of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Marchesi

CONTACT

+393337319707; gloria.marchesi@unicatt.it

Giada Pietrabissa

CONTACT

giada.pietrabissa@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)