NCT04896372: ACTyourCHANGE

The ACTyourCHANGE Study Protocol for Adolescents

Status unknown NA Last updated 20 February 2024

What this trial tests

NA trial testing ACT comprehensive of standard care in Psychological Well-being in 50 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
31 December 2022

31 March 2024

Quick facts

Lead sponsor	Istituto Auxologico Italiano
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 July 2021
Primary completion	31 December 2022
Estimated completion	31 March 2024
Sites	1 location across Italy

Drugs / interventions tested

• ACT comprehensive of standard care
• TAU only

Conditions studied

• Psychological Well-being — all drugs for Psychological Well-being →

Sponsor

Istituto Auxologico Italiano — full company profile →

Who can join

Adults 12 to 17, any sex, with Psychological Well-being. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preliminary Results from the ACTyourCHANGE in Teens Protocol: A Randomized Controlled Trial Evaluating Acceptance and Commitment Therapy for Adolescents with Obesity.
   Guerrini Usubini A, Cattivelli R, Radaelli A, Bottacchi M, et al · · 2022 · cited 9× · PMID 35565031 · DOI 10.3390/ijerph19095635
2. Cognitive Fusion and Emotional Eating among Adolescents with Obesity: A Preliminary Cross-Sectional Study.
   Guerrini Usubini A, Bottacchi M, Caroli D, Castelnuovo G, et al · · 2022 · cited 2× · PMID 36429574 · DOI 10.3390/ijerph192214855