CARESS: An Investigation of Effects of CARESS

Inova Health Care Services

Status: Completed

Conditions: Affective; Reaction; Self Efficacy; Craving; Substance Abuse

Treatments: Behavioral: Isometric Exercise; Behavioral: CARESS

Study type: Interventional

Funder types: Other

Identifiers

NCT03758027

#18-3023

Details and patient eligibility

About

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.

Full 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

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

CARESS

Experimental group

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.

Treatment:

Behavioral: CARESS

ISOMETRIC

Active Comparator group

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

Treatment:

Behavioral: Isometric Exercise