CravingNCT03758027
CARESS: An Investigation of Effects of CARESS
A study testing CARESS and Isometric Exercise in people with Craving and Self Efficacy, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Craving, Self Efficacy, Affective; Reaction
- What is being tested?
- CARESS and Isometric Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 9 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years or older
- meet criteria for problematic drinking or drug use
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Craving, Self Efficacy, Affective; Reaction, Substance Abuse
- Being tested
- CARESS, Isometric Exercise
- Keywords
- emotional regulation, drug taking refusal skills, physiological responses
- Medical subject headings
- Substance-Related Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARESSBehavioural
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.
Isometric ExerciseBehavioural
5-minute protocol for cravings management and affect regulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Isometric Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start30 Oct 2018
- Primary completion30 Jun 2019
- Study completion9 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hadjiyane, Inova Health Care Services
- Investigators
- Maria C Hadjiyane, MA, MS, Principal investigator, Sr. Director Behavioral Health Adult Ambulatory ServicesSylvia Marotta-Walters, PhD, Study chair, Chair, Graduate School of Education and Human Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758027
- Sponsor's protocol ID
- #18-3023
- Status last verified
- Aug 2020
- First submitted
- 27 Sep 2018
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicate Alternatively, Release Endorphins, and Self-Soothe (CARESS) and Emotional Regulation for Cravings Management With Substance Use
- ClinicalTrials.gov ID
- NCT03758027
- Acronym / sponsor ID
- #18-3023
- Conditions
- Craving, Self Efficacy, Affective; Reaction, Substance Abuse
- Keywords
- emotional regulation, drug taking refusal skills, physiological responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CARESS | Experimental | Behavioral: CARESSThe 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. |
| ISOMETRIC | Active comparator | Behavioral: Isometric ExerciseThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be 18 years or older
- meet criteria for problematic drinking or drug use
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARESSThe 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. | Behavioural | CARESS |
| Isometric Exercise5-minute protocol for cravings management and affect regulation | Behavioural | ISOMETRIC |
Primary outcome
Change in Cravings level
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).
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.
3 secondary outcomes
Change in Affect disturbance
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).
Change in Physiological Responses
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).
Change in Drug taking refusal skills
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria C Hadjiyane, MA, MS principal investigator
Sr. Director Behavioral Health Adult Ambulatory Services
Sylvia Marotta-Walters, PhD study chair
Chair, Graduate School of Education and Human Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARESS and Isometric Exercise in people with Craving and Self Efficacy, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cravings level (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.