Substance UseSUENCT06535919
Substance Use Treatment and Its Role in Supporting Social Cognition
An observational study of Substance Use and Empathy, run by Nova Southeastern University at 2 sites in United States.
Trial summary
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, Empathy
- What is being tested?
- Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2024to 22 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Individual receiving treatment at a local addiction treatment center.
Who may be able to join
- Meet criteria for a substance Use Disorder, receiving treatment at Recovery Unplugged Addiction Treatment Center, at least 18 years of age.
Who cannot join
- Neurological disorder, severe cognitive impairment, comorbid thought disorder such as schizophrenia, failure to complete detox period,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Recovery Unplugged
Fort Lauderdale, Florida, 33304
Recovery Unplugged
Lake Worth, Florida, 33461
About this study
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.
Read the 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.
- Conditions
- Substance Use, Empathy
- Being tested
- Treatment as Usual
- Keywords
- substance use, empathy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualBehavioural
Individuals will receive residential level of care followed by treatment at their partial hospitalization program.
| Study group | Role | What they receive |
|---|---|---|
| RUP | Individuals receiving TAU from RUP Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
empathy
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.
Measured: pre to post treatment and 2 month post treatment follow-up (4 months total)
Secondary outcomes (1)
differences in empathy gains by sex
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.
Measured: pre and post treatment, 2 month post treatment follow-up (4 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start22 Oct 2024
- Primary completion22 Aug 2026 (estimated)
- Study completion22 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madison Roopchand, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535919
- Sponsor's protocol ID
- 2024-286
- Acronym
- SUE
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Treatment and Its Role in Supporting Social Cognition
- ClinicalTrials.gov ID
- NCT06535919
- Acronym / sponsor ID
- SUE / 2024-286
- Conditions
- Substance Use, Empathy
- Keywords
- substance use, empathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 22 Aug 2026 (estimated)
- Study completion
- 22 Aug 2026 (estimated)
- First posted
- 2 Aug 2024 (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.
This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RUP | – | Behavioral: Treatment as UsualIndividuals receiving TAU from RUP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individual receiving treatment at a local addiction treatment center.
Key inclusion criteria (1 listed)
- Meet criteria for a substance Use Disorder, receiving treatment at Recovery Unplugged Addiction Treatment Center, at least 18 years of age.
Key exclusion criteria (1 listed)
- Neurological disorder, severe cognitive impairment, comorbid thought disorder such as schizophrenia, failure to complete detox period,
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 |
|---|---|---|
| Treatment as UsualIndividuals will receive residential level of care followed by treatment at their partial hospitalization program. | Behavioural | RUP |
Primary outcome
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.
1 secondary outcome
differences in empathy gains by sex
Time frame: pre and post treatment, 2 month post treatment follow-up (4 months total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use and Empathy, run by Nova Southeastern University at 2 sites 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
empathy (time frame: pre to post treatment and 2 month post treatment follow-up (4 months total)). 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 22 Jul 2026.