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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACT-based intervention
CBT-based intervention
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring ACT, CBT obesity, Eating disorders, Health psychology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ACT-based intervention

    CBT-based intervention included in Usual Care

    Arm Description

    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.

    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)

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    February 23, 2017
    Sponsor
    Istituto Auxologico Italiano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03066531
    Brief Title
    MOTIVOB-(Acceptance and Commitment Therapy Group Intervention for Obesity)Section
    Acronym
    MOTIVOB-ACT
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    January 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istituto Auxologico Italiano

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    ACT, CBT obesity, Eating disorders, Health psychology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    156 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ACT-based intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CBT-based intervention included in Usual Care
    Arm Type
    Active Comparator
    Arm Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    ACT-based intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    CBT-based intervention
    Primary Outcome Measure Information:
    Title
    CORE-OM
    Description
    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.
    Time Frame
    Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months
    Title
    AAQ-II
    Description
    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.
    Time Frame
    Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months
    Secondary Outcome Measure Information:
    Title
    Weight
    Description
    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.
    Time Frame
    Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: between the ages of 18 and 70 years obesity according to the WHO criteria (BMI ≥ 30) fluency in spoken and written Italian language expression of written informed consent Exclusion Criteria: 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) concurrent severe medical condition not related to obesity

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    16443717
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20308357
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25914662
    Citation
    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.
    Results Reference
    background

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

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