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CARESS: An Investigation of Effects of CARESS

Primary Purpose

Craving, Self Efficacy, Affective; Reaction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARESS
Isometric Exercise
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craving focused on measuring emotional regulation, drug taking refusal skills, physiological responses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. be 18 years or older
  2. meet criteria for problematic drinking or drug use

Exclusion Criteria:

  1. having been directly discharged from an inpatient psychiatric admission;
  2. currently under the influence of alcohol or any illicit or non-prescribed drugs;
  3. having received either of the treatment interventions as part of their current treatment;
  4. having current suicidal or homicidal thoughts, plans, or attempts;
  5. experiencing current psychosis; or
  6. unable to read the self-report assessment forms in English without assistance

Sites / Locations

  • Inova Behavioral Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CARESS

ISOMETRIC

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Cravings level
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.

Secondary Outcome Measures

Change in Affect disturbance
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.
Change in Physiological Responses
Identify the change in the galvanic skin response for the participant, utilizing GSR reader
Change in Drug taking refusal skills
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.

Full Information

First Posted
September 27, 2018
Last Updated
August 14, 2020
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT03758027
Brief Title
CARESS: An Investigation of Effects of CARESS
Official Title
Communicate Alternatively, Release Endorphins, and Self-Soothe (CARESS) and Emotional Regulation for Cravings Management With Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
November 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inova Health Care Services

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 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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craving, Self Efficacy, Affective; Reaction, Substance Abuse
Keywords
emotional regulation, drug taking refusal skills, physiological responses

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CARESS
Arm Type
Experimental
Arm 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 Title
ISOMETRIC
Arm Type
Active Comparator
Arm 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(s)
CARESS
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Isometric Exercise
Intervention Description
5-minute protocol for cravings management and affect regulation
Primary Outcome Measure Information:
Title
Change in Cravings level
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.
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).
Secondary Outcome Measure Information:
Title
Change in Affect disturbance
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.
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).
Title
Change in Physiological Responses
Description
Identify the change in the galvanic skin response for the participant, utilizing GSR reader
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).
Title
Change in Drug taking refusal skills
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be 18 years or older meet criteria for problematic drinking or drug use Exclusion Criteria: having been directly discharged from an inpatient psychiatric admission; currently under the influence of alcohol or any illicit or non-prescribed drugs; having received either of the treatment interventions as part of their current treatment; having current suicidal or homicidal thoughts, plans, or attempts; experiencing current psychosis; or unable to read the self-report assessment forms in English without assistance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Hadjiyane, MA, MS
Organizational Affiliation
Sr. Director Behavioral Health Adult Ambulatory Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvia Marotta-Walters, PhD
Organizational Affiliation
Chair, Graduate School of Education and Human Development
Official's Role
Study Chair
Facility Information:
Facility Name
Inova Behavioral Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CARESS: An Investigation of Effects of CARESS

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