Substance Use Treatment and Its Role in Supporting Social Cognition (SUE)

July 21, 2026 updated by: Madison Roopchand, Nova Southeastern University
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite the lack of a consensus on the conceptualization of empathy among researchers and practitioners, psychologists generally agree that empathy and valuable interpersonal relations are contingent upon the willingness to understand another's perspective as well as share feelings and experiences. Adults with a variety of substance use disorders (SUDs) experience impairments in various facets of empathetic processing compared to healthy controls. Impairments in empathy could lead to a weak therapeutic alliance, lower adherence to treatment, and higher relapse rate. Furthermore, the therapeutic relationship has been described as one of the strongest predictors of treatment drop-out for patients with SUDs. In addition, an impaired ability to relate to and understand the affective and mental state of others may contribute to key typologies of patients with SUDs including, impulsivity, aggression, and antisocial behavior. Review of literature emphasizes a need for research into an understudied, yet modifiable factor of empathy in the trajectory of SUDs. Particularly, identifying specific psychotherapeutic techniques capable of improving the expression of empathy in these patients. Given the importance of empathetic ability in optimal social functioning, understanding whether empathetic impairments improve with treatment is important to achieve the best treatment outcomes for individuals struggling with SUDs.This study will help improve the knowledge and understanding of how substance use treatment affects empathy, as measured by gains in empathetic ability in treatment seeking individuals. To date, there are no reported studies that examined the impact of residential SU treatment on empathy. The study will be an observational quasi-experimental design that utilizes a pre-test and post-test to examine change in empathy for recently detoxed substance use patients and a follow-up assessment to monitor long term outcomes. The results of this study will further our understanding of treatment's potential role in cultivating a fundamental interpersonal skill, empathy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33304
        • Recovery Unplugged
      • Lake Worth, Florida, United States, 33461
        • Recovery Unplugged

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individual receiving treatment at a local addiction treatment center.

Description

Inclusion Criteria:

  • Meet criteria for a substance Use Disorder, receiving treatment at Recovery Unplugged Addiction Treatment Center, at least 18 years of age.

Exclusion Criteria:

  • Neurological disorder, severe cognitive impairment, comorbid thought disorder such as schizophrenia, failure to complete detox period,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RUP
Individuals receiving TAU from RUP
Behavioral: Treatment as Usual
Individuals will receive residential level of care followed by treatment at their partial hospitalization program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
empathy
Time Frame: pre to post treatment and 2 month post treatment follow-up (4 months total)
The Empathy Quotient-Short (EQ-Short) is a self-report questionnaire designed to assess individual differences in empathy. It is used to measure levels of empathy, including affective, cognitive, and total empathy. The unit of measure for the outcome is the total empathy score derived from responses to 22 items, with each item rated on a 4-point Likert scale ranging from 1 ("I strongly disagree") to 4 ("I strongly agree"). Possible range 0-44, Higher scores indicate greater empathy. For example, one of the items asks, "I can pick up quickly if someone says one thing but means another." This scale is designed to assess various facets of empathy, including the ability to recognize emotions in others (cognitive empathy) and the ability to share or respond to those emotions (affective empathy). Previous multivariate analyses suggest that the Empathy Quotient-Short is a reliable and adequate tool for assessing individual differences in empathizing.
pre to post treatment and 2 month post treatment follow-up (4 months total)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
differences in empathy gains by sex
Time Frame: pre and post treatment, 2 month post treatment follow-up (4 months total)
A secondary outcome of this study is to assess differences in empathy gains between men and women. Specifically, the study will examine how levels of empathy change over time as a function of sex. Empathy will be measured using the Empathy Quotient-Short (EQ-Short), which evaluates affective, cognitive, and total empathy. The unit of measure for this outcome is the change in total empathy scores before and after the intervention, with the empathy score calculated based on participants' responses to 22 items on a 4-point Likert scale. The analysis will focus on comparing the magnitude of empathy changes between male and female participants to identify potential differences in the extent to which empathy increases for each sex. This will provide insight into whether the intervention leads to varying levels of empathy development based on sex.
pre and post treatment, 2 month post treatment follow-up (4 months total)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Substance Use
Time Frame: Baseline and 2 months post treatment follow-up
The Brief Addiction Monitor (BAM) (Cacciola et al., 2013) is a 17-item self-report questionnaire used to assess substance use behaviors. The tool includes three subscales: (1) Current Use, (2) Current Risk, and (3) Protective Factors. The unit of measure for this outcome is the frequency and intensity of substance use behaviors, as assessed by responses to individual items within the subscales. Of the 17 items, 16 are single-response, and one is a multi-response item regarding drug use frequency. Specifically, ten items are rated on a 5-point Likert scale (0 to 10), denoting the number of days participants engaged in substance-related behaviors. Five items are rated on a 5-point ordinal scale ranging from (1) "Not at All" to (5) "Extremely," one item uses a binary scale (Yes/No), and one item is rated from "poor" to "excellent." At Time 2 and Time 3 assessments during treatment, the substance use-related items will be omitted. Use scale range 0-12 Higher scores indicate greater SU.
Baseline and 2 months post treatment follow-up
Social Support
Time Frame: Baseline and post treatment as well as 2 month post treatment follow-up
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report questionnaire used to assess an individual's perception of social support from three key sources: family, friends, and a significant other. The unit of measure for this outcome is the perceived level of social support, with responses rated on a 7-point Likert scale ranging from (1) "I very strongly disagree" to (7) "I very strongly agree." For example, one item asks, "There is a special person who is around when I am in need." Score range 12-84, higher scores reflect greater perceived availability and adequacy of social support from family, friends, and significant others. The Multidimensional Scale of Perceived Social Support has demonstrated strong internal consistency, test-retest reliability, validity, and a stable factorial structure across multiple studies, making it a reliable tool for measuring perceived social support.
Baseline and post treatment as well as 2 month post treatment follow-up
Report of therapist Emapthy
Time Frame: Baseline, pre-discharge from residential , pre-discharge from PHP
The Barrett-Lennard Relationship Inventory-Empathy (BLRI-Empathy) is a self-report measure of empathy that is widely used in therapeutic settings. The unit of measure for this outcome is the perceived level of empathy, with participants rating their perception of the therapist's empathy and therapists rating their perception of the patient's empathy. The empathy subscale consists of 16 items (e.g., "My therapist understands me"), which are rated on a 6-point Likert scale ranging from (-3) "I strongly feel that it is not true" to (3) "I strongly feel that it is true." Scores range 16-96 higher scores reflect greater perceived therapist empathy. The Barrett-Lennard Relationship Inventory-Empathy has demonstrated strong internal consistency, test-retest reliability, and both convergent and divergent validity, as well as predictive validity in past research, supporting its use as a reliable tool for assessing empathy in therapeutic relationships.
Baseline, pre-discharge from residential , pre-discharge from PHP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Southeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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