The ACTyourCHANGE Study Protocol for Adolescents

Summary

This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a brief Acceptance and Commitment Therapy (ACT)-based-intervention combined with treatment as usual (TAU) compared to TAU only in improving psychological conditions in a sample of adolescents with obesity (body mass index, BMI \> 97th centile for age and sex). Fifty consecutive adolescents (12-17 years) of both genders with obesity will be recruited among the patients hospitalized in a clinical center for obesity rehabilitation and randomly allocated into two experimental conditions: ACT + TAU vs TAU only. Both groups will attend a three-week in-hospital multidisciplinary rehabilitation program for weight loss. The ACT + TAU condition comprises a psychological intervention based on ACT combined with a standard psychological assessment and support to the hospitalization. The TAU comprises the standard psychological assessment and support to the hospitalization. At pre- to post-psychological intervention participants will complete the Avoidance and Fusion Questionnaire for Youth, the Psychological Well-Being Scale, the Depression Anxiety Stress Scale, the Difficulties in Emotion Regulation Scale, and the Emotional Eating subscale of the Dutch Eating Behavior Questionnaire. Repeated-measures ANOVAs (2x2) will be conducted. The study will assess the effectiveness of a brief ACT-based intervention for adolescents with obesity.

Conditions

• Psychological Well-being

Interventions

OTHER

ACT comprehensive of standard care

The proposed intervention was designed by the authors of the study. It was developed following the main ACT-based manuals, with adjustments according to the users and the context of the study implementation. Specifically, we developed a practical and interactive intervention, which comprises practical activities such as roleplay and writing activities and imaginative activities supported by metaphors. The sessions are based on the use of age-appropriate language to convey the most complex therapeutic processes easily. According to Strosahl and colleagues' model, sessions will respectively target the components of openness, awareness, and engagement.

OTHER

TAU only

adolescents will be assessed by a staff dietician and placed on an individualized hy-pocaloric balanced Mediterranean diet. They will also follow a nutritional counselling aimed at promoting the adoption of a healthy lifestyle. Moreover, they will attend a physical activity program consisting of five training sessions per week lasting one hour each with trainers; In addition, they will be involved in psychological counselling pro-vided once a week by a clinical psychologist, aimed to address psychological factors related to dysfunctional lifestyle habits.

Sponsors & Collaborators

• Istituto Auxologico Italiano

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2022-12-31

Completion

2024-03-31

Countries

• Italy

Study Locations