- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06535919
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
RUP
Individuals receiving TAU from RUP
|
Individuals will receive residential level of care followed by treatment at their partial hospitalization program.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
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)
October 22, 2024
Primary Completion (Estimated)
August 22, 2026
Study Completion (Estimated)
August 22, 2026
Study Registration Dates
First Submitted
July 30, 2024
First Submitted That Met QC Criteria
July 30, 2024
First Posted (Actual)
August 2, 2024
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 21, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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
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