<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721499</url>
  </required_header>
  <id_info>
    <org_study_id>0809004271</org_study_id>
    <nct_id>NCT01721499</nct_id>
  </id_info>
  <brief_title>Decreasing Stress and Improving Self-control With &quot;Stress in Control&quot; (Sync) Training</brief_title>
  <acronym>Sync</acronym>
  <official_title>Decreasing Stress and Improving Self-control With &quot;Stress in Control&quot; (Sync) Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of treatment approaches aimed to improve self-control and decrease stress and&#xD;
      unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.&#xD;
&#xD;
      High levels of stress may make it harder to maintain self-control, especially when trying to&#xD;
      control our unhealthy behaviors. Training on improving self control and decreasing stress may&#xD;
      help decrease unhealthy behaviors. The goal of this new training program will be to decrease&#xD;
      a subject's unhealthy behavior by helping them better manage their stress and improve their&#xD;
      self control over unhealthy habits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study proposes to pilot a mindfulness based affect-regulation treatment approach to&#xD;
      improve self-control and physiological and biochemical indicators of stress, as well as&#xD;
      decrease unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. The broad&#xD;
      aims of the treatment approach will be to teach participants to (1) observe and increase&#xD;
      awareness of cognitive, affective, bodily sensations/expressions and action-urge components&#xD;
      of emotional/compulsion experiences; and (2) develop alternate affective, behavioral and&#xD;
      cognitive coping strategies in managing and regulating affect/urge experiences. It is hoped&#xD;
      that the findings from this study will aid in the further development of treatment and&#xD;
      prevention programs targeting stress reduction and coping to improve control over maladaptive&#xD;
      behaviors and decrease physical and mental health symptoms.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
        1. Develop a mindfulness based affect-regulation therapy manual, and training materials to&#xD;
           train therapists on a treatment approach aimed at improving self-control over unhealthy&#xD;
           addictive behaviors.&#xD;
&#xD;
        2. Develop and implement &quot;Stress in Control&quot; (SynC) training competence and adherence&#xD;
           rating scales;&#xD;
&#xD;
        3. Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness&#xD;
           and feasibility of SynC in comparison to a Primary Care Treatment Control Group and a&#xD;
           Historical Control Group approach for 100 individuals interested in help in decreasing&#xD;
           targeted unhealthy behaviors. Primary outcomes will be a reduction in unhealthy problem&#xD;
           behaviors, and secondary outcomes will be decrease in measures of stress, and increases&#xD;
           in emotion regulation and self control.&#xD;
&#xD;
        4. (secondary aim) Collect baseline data on measures of self control, mood, coping,&#xD;
           personality, cognitive functioning, acute and chronic stress, and mental and physical&#xD;
           health on a large sample of subjects seeking help in decreasing unhealthy behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development of treatment approaches</measure>
    <time_frame>1 year</time_frame>
    <description>Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure effectiveness of intervention</measure>
    <time_frame>2 years</time_frame>
    <description>Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Stress</condition>
  <condition>Obesity</condition>
  <condition>Overeating</condition>
  <arm_group>
    <arm_group_label>Mindfulness intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mindfulness intervention consists of weekly group format mindfulness instruction and skills development, weekly individual therapy sessions, and 6 nutritional sessions.&#xD;
The control group receives 6 nutritional sessions only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group receives 6 nutritional counseling sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Counseling</intervention_name>
    <description>weekly group and individual skills training to improve self control and decrease stress.</description>
    <arm_group_label>Mindfulness intervention</arm_group_label>
    <arm_group_label>Nutrition Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Intervention</intervention_name>
    <arm_group_label>Mindfulness intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between ages 18-60 years;&#xD;
&#xD;
          2. Able to read and write;&#xD;
&#xD;
          3. Interested in treatment aimed at gaining greater control over an unhealthy,&#xD;
             maladaptive behavior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any psychotic disorder or current psychiatric symptoms requiring specific attention,&#xD;
             including active symptoms of psychosis or suicidal/homicidal ideation&#xD;
&#xD;
          2. Pregnant women will be excluded.&#xD;
&#xD;
          3. Inability to give informed consent&#xD;
&#xD;
          4. Traumatic brain injury or loss of consciousness&#xD;
&#xD;
          5. Medical problems requiring immediate attention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajita Sinha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>March 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>July 28, 2015</last_update_submitted>
  <last_update_submitted_qc>July 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Rajita Sinha</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>obesity</keyword>
  <keyword>overeating</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperphagia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721499
org study id: 0809004271
nct id: NCT01721499
lead sponsor: 
has dmc: No
This is a study of treatment approaches aimed to improve self-control and decrease stress and
      unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.

      High levels of stress may make it harder to maintain self-control, especially when trying to
      control our unhealthy behaviors. Training on improving self control and decreasing stress may
      help decrease unhealthy behaviors. The goal of this new training program will be to decrease
      a subject's unhealthy behavior by helping them better manage their stress and improve their
      self control over unhealthy habits.
This study proposes to pilot a mindfulness based affect-regulation treatment approach to
      improve self-control and physiological and biochemical indicators of stress, as well as
      decrease unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. The broad
      aims of the treatment approach will be to teach participants to (1) observe and increase
      awareness of cognitive, affective, bodily sensations/expressions and action-urge components
      of emotional/compulsion experiences; and (2) develop alternate affective, behavioral and
      cognitive coping strategies in managing and regulating affect/urge experiences. It is hoped
      that the findings from this study will aid in the further development of treatment and
      prevention programs targeting stress reduction and coping to improve control over maladaptive
      behaviors and decrease physical and mental health symptoms.

      Aims:

        1. Develop a mindfulness based affect-regulation therapy manual, and training materials to
           train therapists on a treatment approach aimed at improving self-control over unhealthy
           addictive behaviors.

        2. Develop and implement "Stress in Control" (SynC) training competence and adherence
           rating scales;

        3. Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness
           and feasibility of SynC in comparison to a Primary Care Treatment Control Group and a
           Historical Control Group approach for 100 individuals interested in help in decreasing
           targeted unhealthy behaviors. Primary outcomes will be a reduction in unhealthy problem
           behaviors, and secondary outcomes will be decrease in measures of stress, and increases
           in emotion regulation and self control.

        4. (secondary aim) Collect baseline data on measures of self control, mood, coping,
           personality, cognitive functioning, acute and chronic stress, and mental and physical
           health on a large sample of subjects seeking help in decreasing unhealthy behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Development of treatment approaches
time frame: 1 year
description: Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.
measure: Measure effectiveness of intervention
time frame: 2 years
description: Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment
arm group label: Mindfulness intervention
arm group type: Experimental
description: The mindfulness intervention consists of weekly group format mindfulness instruction and skills development, weekly individual therapy sessions, and 6 nutritional sessions.
The control group receives 6 nutritional sessions only.
arm group label: Nutrition Control Group
arm group type: Active Comparator
description: The control group receives 6 nutritional counseling sessions.
intervention type: Behavioral
intervention name: Nutritional Counseling
description: weekly group and individual skills training to improve self control and decrease stress.
arm group label: Mindfulness intervention
arm group label: Nutrition Control Group
intervention type: Behavioral
intervention name: Mindfulness Intervention
arm group label: Mindfulness intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rajita Sinha, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Rajita Sinha
investigator title: Professor
mesh term: Hyperphagia