Clinical trial NCT03758027: 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
Overall status: COMPLETED
Phase: NA
Conditions: Craving
Self Efficacy
Affective; Reaction
Substance Abuse
Keywords: emotional regulation
drug taking refusal skills
physiological responses
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cravings level
timeFrame: 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:
measure: Change in Affect disturbance
timeFrame: 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).
measure: Change in Physiological Responses
timeFrame: 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).
measure: Change in Drug taking refusal skills
timeFrame: 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).
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Behavioral Health
state: Virginia
Study officials:
affiliation: Sr. Director Behavioral Health Adult Ambulatory Services
name: Maria C Hadjiyane, MA, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair, Graduate School of Education and Human Development
name: Sylvia Marotta-Walters, PhD
role: STUDY_CHAIR
References: