CARESS: An Investigation of Effects of CARESS

NCT03758027 | Completed

• 1 other identifier: #18-3023
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Craving; Self Efficacy; Affective; Reaction; Substance Abuse

Keywords

emotional regulation; drug taking refusal skills; physiological responses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Affect disturbance

  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

  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

  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).

Study Arms (2)

CARESS

EXPERIMENTAL

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

ISOMETRIC

ACTIVE COMPARATOR

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

Interventions

CARESS BEHAVIORAL

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.

CARESS

Isometric Exercise BEHAVIORAL

5-minute protocol for cravings management and affect regulation

ISOMETRIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 18 years or older
• meet criteria for problematic drinking or drug use

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Behavioral Health

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Emotional Regulation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria C Hadjiyane, MA, MS

  Sr. Director Behavioral Health Adult Ambulatory Services

  PRINCIPAL INVESTIGATOR

• Sylvia Marotta-Walters, PhD

  Chair, Graduate School of Education and Human Development

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Director, Behavioral Health Adult Ambulatory Services

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: November 29, 2018
• Study Start: October 30, 2018
• Primary Completion: June 30, 2019
• Study Completion: November 9, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)