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

NCT ID: NCT03066531

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2016-01-01

Brief Summary

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ACT-based intervention

Intervention Type: BEHAVIORAL

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)

Group Type: ACTIVE_COMPARATOR

CBT-based intervention

Intervention Type: BEHAVIORAL

Interventions

ACT-based intervention

Intervention Type: BEHAVIORAL

CBT-based intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 16443717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20308357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25914662 (View on PubMed)

Other Identifiers

03C101

Identifier Type: -

Identifier Source: org_study_id