MOTIVOB-(Acceptance and Commitment Therapy Group Intervention for Obesity)Section (MOTIVOB-ACT)

Acting Flexible, Acting Resistant: the Upsides of an ACT Choice. A Randomized Comparison of Acceptance and Commitment Therapy Group Intervention and Cognitive Behavioral Therapy Group for the Treatment of Obese Patients

The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT) group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese individuals with respect to mid-term outcome.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: ACT-based intervention; Behavioral: CBT-based intervention

Detailed Description

Effective weight-management programs often include a combination of physical activity, diet, and psychological intervention, in particular Cognitive Behavioral Therapy (CBT). The effects of these programs are frequently not stable, and usually the maintenance of achieved weight-loss lasts only for a short period of time. Acceptance and Commitment Therapy, ACT, keeps on gaining recognition in obesity treatment. The purpose of the study is to compare weight loss and indicator of psychological functioning in a population of obese subjects belonging to three different diagnostic categories: without ED, with ED NAS and with BED. Participants were exposed respectively to a CBT or an ACT treatment and were assessed three times: pre intervention, post intervention and follow-up. The investigators hypothesize that CBT and ACT are both effective in the post-intervention. ACT intervention should be more effective in the follow-up both for weight and psychological functioning, due to its focus on the flexible managing of the global context instead of the focus on the pathology itself, more typical in standard CBT treatment.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. between the ages of 18 and 70 years
2. obesity according to the WHO criteria (BMI ≥ 30)
3. fluency in spoken and written Italian language
4. expression of written informed consent

Exclusion Criteria:

1. other severe psychiatric disturbance different form eating disorders diagnosed by DSM-5 criteria (SCID-Structured Clinical Interview for DSM-IV-TR Disorders I and II and DSM 5 manual, administered by an independent clinical psychologist, were used as screening tools for psychiatric disorders)
2. concurrent severe medical condition not related to obesity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT-based intervention; The ACT-based intervention integrates educational topics on heart healthy behaviours with mindfulness and acceptance training regarding difficult thoughts and feelings, clarification of health-related values and commitment to behave in the valued direction while contacting difficult experiences.	Behavioral: ACT-based intervention
Active Comparator: CBT-based intervention included in Usual Care; These programs are based on current guidelines for the long- term multi-disciplinary rehabilitation and prevention of obese patients, including Cognitive Behavioral Therapy (CBT), in a group setting, as Gold Standard. Assigned Interventions: Behavioral: usual care (CBT)	Behavioral: CBT-based intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CORE-OM	The change in the score of CORE-OM measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up. CORE-OM (Italian version by Palmieri et al., 2009) is a self-report measure designed for use as a baseline and outcome measure in psychological therapies and after its conclusion. It assesses the subjective experience of a person, as well as the way he or she functions in the world. It is composed by 34 items on a 5-points likert-scale from 0 (never) to 4 (always). Low scores correspond to high wellbeing. The CORE-OM provided 5 scales: wellness, symptoms, functioning, risk and total. The investigator involved in administering and interpreting the CORE-OM were blinded to treatment assignment.	Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months
AAQ-II	The change in the score of AAQ-II measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up.The Acceptance and Action Questionnaire (AAQ; Hayes et al., 2004) is the most widely used measure of experiential avoidance and psychological inflexibility. We used the 7-item Italian (7-points likert-scale from 0-never true to 7-always true) version of AAQ-II (Pennato, Berrocal, Bernini & Rivas, 2013) that shows adequate indexes of validity and reliability with a single-factor structure. In the case of AAQ-II higher scores indicate greater psychological flexibility.	Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	The change in the weight, expressed in kilograms, measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up.	Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Publications and helpful links

General Publications

• Cattivelli R, Pietrabissa G, Ceccarini M, Spatola CA, Villa V, Caretti A, Gatti A, Manzoni GM, Castelnuovo G. ACTonFOOD: opportunities of ACT to address food addiction. Front Psychol. 2015 Apr 9;6:396. doi: 10.3389/fpsyg.2015.00396. eCollection 2015. No abstract available.
• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
• Juarascio AS, Forman EM, Herbert JD. Acceptance and commitment therapy versus cognitive therapy for the treatment of comorbid eating pathology. Behav Modif. 2010 Mar;34(2):175-90. doi: 10.1177/0145445510363472.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ACT; Eating disorders; CBT obesity; Health psychology
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 03C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No