<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <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/NCT03758027</url>
  </required_header>
  <id_info>
    <org_study_id>#18-3023</org_study_id>
    <nct_id>NCT03758027</nct_id>
  </id_info>
  <brief_title>CARESS: An Investigation of Effects of CARESS</brief_title>
  <official_title>Communicate Alternatively, Release Endorphins, and Self-Soothe (CARESS) and Emotional Regulation for Cravings Management With Substance Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to study the efficacy of an intervention that could interrupt&#xD;
      the cycle of emotion dysregulation as it relates to cravings and negative emotions for those&#xD;
      with problematic substance use behaviors. This will be a quantitative randomized control&#xD;
      trial study with data collection at three points: pre-intervention, post-intervention, and&#xD;
      same-day follow up. This study will be conducted at the Inova Behavioral Health Merrifield&#xD;
      Center. Inova's addictions services program is the CATS program (formerly comprehensive&#xD;
      addiction treatment services), which provides therapeutic interventions for those managing&#xD;
      substance use disorders. The focus of measurement will be about the current state of the&#xD;
      participant, and not a cumulative status. This one-session intervention. The goal is to have&#xD;
      96 participants in the study, 48 in each of the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The conceptual framework for the study is built on a foundation of three models found in the&#xD;
      literature. The first of these is Gross's model of emotional regulation (ER), a goal-oriented&#xD;
      linear process allowing for interventions at different phases in the experience. The&#xD;
      individual has choices to: (1) avoid a situation all together; (2) deflect or distract from&#xD;
      the situation; (3) reframe the situation; (4) or manage the physiological reactions. Adding&#xD;
      on to this model, Koole expanded the framework, and reclassified the processes as tasks&#xD;
      toward a goal, while adding an array of functions for each task. This includes where he/she&#xD;
      is focusing, what he/she is thinking, and how he/she is responding. This allows the&#xD;
      individual more choices in managing the emotions, depending on what he/she is trying to&#xD;
      achieve. Finally, applying a taxonomy developed by Webb et al. (2012) of interventions to&#xD;
      this framework, the identification of types of interventions is clarified. The framework is&#xD;
      then applied to the proposed intervention, CARESS.&#xD;
&#xD;
      The proposed study will investigate a specific intervention and its efficacy at managing the&#xD;
      acute effects for cravings, drug and drinking refusal self-efficacy, physiological responses,&#xD;
      and affect disturbance for those with problematic substance use behaviors. The intervention&#xD;
      is a one-time treatment session using CARESS in comparison to a control group who do not&#xD;
      receive CARESS for those with problematic substance use behaviors. The aim is to investigate&#xD;
      the difference in variances between pre, post, and follow up measurements for cravings, drug&#xD;
      and drinking refusal skill self-efficacy, affect disturbance, and physiological responses for&#xD;
      a one-time treatment session using CARESS in comparison to a control group for those with&#xD;
      problematic substance use behaviors.&#xD;
&#xD;
      This is the initial study with respect to CARESS overall&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Actual">November 9, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This will be a randomized control trial with an experimental and control group. There will be a total of 96 participants, 48 in each group. For research question, a 2 X 3 repeated measures MANOVA will be conducted.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cravings level</measure>
    <time_frame>The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).</time_frame>
    <description>To identify the change in intensity and characteristics of cravings, using the Penn Alcohol Craving Scale (PACS). The Penn Alcohol Craving Scale (PACS) is a self-report tool addressing the frequency, intensity, and duration of craving, as well as the self-efficacy in the resistance to drink, and a comprehensive cravings measurement. Each question is on a Likert-scale with answers from zero (0) to six (6) and scores of questions one through four ranging from zero to 30, with no subscales. The lower the score the lower the craving, therefore a better outcome. The initial study of the PACS supported content, predictive and construct validity. There is an internal consistency of .92 Cronbach's alpha.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Affect disturbance</measure>
    <time_frame>The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).</time_frame>
    <description>To identify the change in affect disturbance, the Positive Affect and Negative Affect Schedule (PANAS) instrument will be used. The PANAS is a 20-question instrument with 10 emotions listed for positive affect, and 10 emotions listed for negative affect. These are scored on a 5-point Likert scale, measuring the positive and negative affects an individual is experiencing at a specific moment in time. Although both scales are on the instrument, they do not measure the same continuum. The Positive affect subscale: questions 1, 3, 5, 9, 10, 12, 14, 16, 17, &amp; 19, with scores ranging from 10 - 50; higher scores indicate more of a positive affect. The Cronbach's alpha for the positive affect subscale ranges from .86-.90. The Negative affect subscale: questions 2, 4, 6, 7, 8, 11, 13, 15, 18, &amp; 20 with scores ranging from 10 - 50; lower scores indicate less of a negative affect. The Cronbach's alpha for the negative affect, a range of .84-.87.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physiological Responses</measure>
    <time_frame>The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).</time_frame>
    <description>Identify the change in the galvanic skin response for the participant, utilizing GSR reader</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Drug taking refusal skills</measure>
    <time_frame>The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).</time_frame>
    <description>Identify the change in perception of self-efficacy on drug refusal skills, utilizing Drug-Taking Confidence Questionnaire. The DTCQ-8 assesses a participant's confidence that he/she would not use drugs or drink in different scenarios of high-risk situations. The 8 questions each correspond to relapse predictors. Each item is scored on a scale of 0 to 100, in intervals of 20: 0, 0% not at all confident I would be able to resist; 20, 20% confidence to resist; 40, 40% confident; 60, 60% confident; 80, 80% confident; and 100, 100% very confident. There are two versions of the DTCQ-8, one for alcohol and one for drugs, the measurements are the same and the wording in the instructions is slightly different. It is recommended that the appropriate instrument be used for the drug of choice of the client. In order to score the full instrument, a global self-efficacy score is calculated by averaging the scored items; the higher the score, the greater the self-efficacy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Craving</condition>
  <condition>Self Efficacy</condition>
  <condition>Affective; Reaction</condition>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>CARESS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The proposed intervention for this study has three stages: communicate alternatively (CA), release endorphins (RE), and self-soothe (SS) (CARESS)&#xD;
CARESS is a combined skill of three activities. Each section is timed and has specific activities:&#xD;
CA - will last eight (8) minutes, and will be expression of emotion with drawing with crayons.&#xD;
RE - will last six (6) minutes, and will be a butterfly hug with a blanket. SS - will last six (6) minutes, and will be a pre-recorded music selection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ISOMETRIC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is a one time five-minute isometric circuit involving contracting muscles in different parts of the body. In order to be equivalent in time spent with the experimental intervention, this circuit will be performed three times with a five-minute break between each instance</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CARESS</intervention_name>
    <description>The goals of each component are as follows:&#xD;
Communicate alternatively - a method to bring the brain back and remove the individual from his/her limbic system;&#xD;
Release endorphins - a release for the internal stress created by the emotion; and&#xD;
Self-soothe - a method of quelling and containing.</description>
    <arm_group_label>CARESS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Isometric Exercise</intervention_name>
    <description>5-minute protocol for cravings management and affect regulation</description>
    <arm_group_label>ISOMETRIC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. be 18 years or older&#xD;
&#xD;
          2. meet criteria for problematic drinking or drug use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. having been directly discharged from an inpatient psychiatric admission;&#xD;
&#xD;
          2. currently under the influence of alcohol or any illicit or non-prescribed drugs;&#xD;
&#xD;
          3. having received either of the treatment interventions as part of their current&#xD;
             treatment;&#xD;
&#xD;
          4. having current suicidal or homicidal thoughts, plans, or attempts;&#xD;
&#xD;
          5. experiencing current psychosis; or&#xD;
&#xD;
          6. unable to read the self-report assessment forms in English without assistance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria C Hadjiyane, MA, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sr. Director Behavioral Health Adult Ambulatory Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvia Marotta-Walters, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chair, Graduate School of Education and Human Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inova Behavioral Health</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inova Health Care Services</investigator_affiliation>
    <investigator_full_name>Maria Hadjiyane</investigator_full_name>
    <investigator_title>Senior Director, Behavioral Health Adult Ambulatory Services</investigator_title>
  </responsible_party>
  <keyword>emotional regulation</keyword>
  <keyword>drug taking refusal skills</keyword>
  <keyword>physiological responses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03758027
org study id: #18-3023
nct id: NCT03758027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to study the efficacy of an intervention that could interrupt
      the cycle of emotion dysregulation as it relates to cravings and negative emotions for those
      with problematic substance use behaviors. This will be a quantitative randomized control
      trial study with data collection at three points: pre-intervention, post-intervention, and
      same-day follow up. This study will be conducted at the Inova Behavioral Health Merrifield
      Center. Inova's addictions services program is the CATS program (formerly comprehensive
      addiction treatment services), which provides therapeutic interventions for those managing
      substance use disorders. The focus of measurement will be about the current state of the
      participant, and not a cumulative status. This one-session intervention. The goal is to have
      96 participants in the study, 48 in each of the two groups.
The conceptual framework for the study is built on a foundation of three models found in the
      literature. The first of these is Gross's model of emotional regulation (ER), a goal-oriented
      linear process allowing for interventions at different phases in the experience. The
      individual has choices to: (1) avoid a situation all together; (2) deflect or distract from
      the situation; (3) reframe the situation; (4) or manage the physiological reactions. Adding
      on to this model, Koole expanded the framework, and reclassified the processes as tasks
      toward a goal, while adding an array of functions for each task. This includes where he/she
      is focusing, what he/she is thinking, and how he/she is responding. This allows the
      individual more choices in managing the emotions, depending on what he/she is trying to
      achieve. Finally, applying a taxonomy developed by Webb et al. (2012) of interventions to
      this framework, the identification of types of interventions is clarified. The framework is
      then applied to the proposed intervention, CARESS.

      The proposed study will investigate a specific intervention and its efficacy at managing the
      acute effects for cravings, drug and drinking refusal self-efficacy, physiological responses,
      and affect disturbance for those with problematic substance use behaviors. The intervention
      is a one-time treatment session using CARESS in comparison to a control group who do not
      receive CARESS for those with problematic substance use behaviors. The aim is to investigate
      the difference in variances between pre, post, and follow up measurements for cravings, drug
      and drinking refusal skill self-efficacy, affect disturbance, and physiological responses for
      a one-time treatment session using CARESS in comparison to a control group for those with
      problematic substance use behaviors.

      This is the initial study with respect to CARESS overall
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a randomized control trial with an experimental and control group. There will be a total of 96 participants, 48 in each group. For research question, a 2 X 3 repeated measures MANOVA will be conducted.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Cravings level
time frame: The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).
description: To identify the change in intensity and characteristics of cravings, using the Penn Alcohol Craving Scale (PACS). The Penn Alcohol Craving Scale (PACS) is a self-report tool addressing the frequency, intensity, and duration of craving, as well as the self-efficacy in the resistance to drink, and a comprehensive cravings measurement. Each question is on a Likert-scale with answers from zero (0) to six (6) and scores of questions one through four ranging from zero to 30, with no subscales. The lower the score the lower the craving, therefore a better outcome. The initial study of the PACS supported content, predictive and construct validity. There is an internal consistency of .92 Cronbach's alpha.
measure: Change in Affect disturbance
time frame: The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).
description: To identify the change in affect disturbance, the Positive Affect and Negative Affect Schedule (PANAS) instrument will be used. The PANAS is a 20-question instrument with 10 emotions listed for positive affect, and 10 emotions listed for negative affect. These are scored on a 5-point Likert scale, measuring the positive and negative affects an individual is experiencing at a specific moment in time. Although both scales are on the instrument, they do not measure the same continuum. The Positive affect subscale: questions 1, 3, 5, 9, 10, 12, 14, 16, 17, & 19, with scores ranging from 10 - 50; higher scores indicate more of a positive affect. The Cronbach's alpha for the positive affect subscale ranges from .86-.90. The Negative affect subscale: questions 2, 4, 6, 7, 8, 11, 13, 15, 18, & 20 with scores ranging from 10 - 50; lower scores indicate less of a negative affect. The Cronbach's alpha for the negative affect, a range of .84-.87.
measure: Change in Physiological Responses
time frame: The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).
description: Identify the change in the galvanic skin response for the participant, utilizing GSR reader
measure: Change in Drug taking refusal skills
time frame: The single session is will last 2 hours, the intervention will last 20 minutes. The measures will be taken prior to the intervention, (pre-), immediately after the intervention, (post-), and 30 minutes after the conclusion (follow up).
description: Identify the change in perception of self-efficacy on drug refusal skills, utilizing Drug-Taking Confidence Questionnaire. The DTCQ-8 assesses a participant's confidence that he/she would not use drugs or drink in different scenarios of high-risk situations. The 8 questions each correspond to relapse predictors. Each item is scored on a scale of 0 to 100, in intervals of 20: 0, 0% not at all confident I would be able to resist; 20, 20% confidence to resist; 40, 40% confident; 60, 60% confident; 80, 80% confident; and 100, 100% very confident. There are two versions of the DTCQ-8, one for alcohol and one for drugs, the measurements are the same and the wording in the instructions is slightly different. It is recommended that the appropriate instrument be used for the drug of choice of the client. In order to score the full instrument, a global self-efficacy score is calculated by averaging the scored items; the higher the score, the greater the self-efficacy.
arm group label: CARESS
arm group type: Experimental
description: The proposed intervention for this study has three stages: communicate alternatively (CA), release endorphins (RE), and self-soothe (SS) (CARESS)
CARESS is a combined skill of three activities. Each section is timed and has specific activities:
CA - will last eight (8) minutes, and will be expression of emotion with drawing with crayons.
RE - will last six (6) minutes, and will be a butterfly hug with a blanket. SS - will last six (6) minutes, and will be a pre-recorded music selection.
arm group label: ISOMETRIC
arm group type: Active Comparator
description: This is a one time five-minute isometric circuit involving contracting muscles in different parts of the body. In order to be equivalent in time spent with the experimental intervention, this circuit will be performed three times with a five-minute break between each instance
intervention type: Behavioral
intervention name: CARESS
description: The goals of each component are as follows:
Communicate alternatively - a method to bring the brain back and remove the individual from his/her limbic system;
Release endorphins - a release for the internal stress created by the emotion; and
Self-soothe - a method of quelling and containing.
arm group label: CARESS
intervention type: Behavioral
intervention name: Isometric Exercise
description: 5-minute protocol for cravings management and affect regulation
arm group label: ISOMETRIC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maria C Hadjiyane, MA, MS
role: Principal Investigator
affiliation: Sr. Director Behavioral Health Adult Ambulatory Services
last name: Sylvia Marotta-Walters, PhD
role: Study Chair
affiliation: Chair, Graduate School of Education and Human Development
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Inova Health Care Services
investigator full name: Maria Hadjiyane
investigator title: Senior Director, Behavioral Health Adult Ambulatory Services
mesh term: Substance-Related Disorders
sharing ipd: No