CARESS: An Investigation of Effects of CARESS

Communicate Alternatively, Release Endorphins, and Self-Soothe (CARESS) and Emotional Regulation for Cravings Management With Substance Use

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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse; Self Efficacy; Craving; Affective; Reaction
• Intervention / Treatment: Behavioral: CARESS; Behavioral: Isometric Exercise

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Behavioral Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARESS; 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.	Behavioral: CARESS; 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.
Active Comparator: ISOMETRIC; 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	Behavioral: Isometric Exercise; 5-minute protocol for cravings management and affect regulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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).
Change in Physiological Responses	Identify the change in the galvanic skin response for the participant, utilizing GSR reader	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).
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.	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).

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Maria C Hadjiyane, MA, MS, Sr. Director Behavioral Health Adult Ambulatory Services; Study Chair: Sylvia Marotta-Walters, PhD, Chair, Graduate School of Education and Human Development

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): November 9, 2019

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: physiological responses; emotional regulation; drug taking refusal skills
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: #18-3023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No