NCT06535919

Brief Summary

This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 22, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

July 30, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

substance use, empathy

Outcome Measures

Primary Outcomes (1)

  • 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"). 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 Outcomes (1)

  • differences in empathy gains by sex

    pre and post treatment, 2 month post treatment follow-up (4 months total)

Other Outcomes (8)

  • Substance Use

    Baseline and 2 months post treatment follow-up

  • Social Support

    Baseline and post treatment as well as 2 month post treatment follow-up

  • Therapeutic Alliance

    Baseline, pre-discharge from residential and at PHP treatment pre-discharge

  • +5 more other outcomes

Study Arms (1)

RUP

Individuals receiving TAU from RUP

Behavioral: Treatment as Usual

Interventions

Individuals will receive residential level of care followed by treatment at their partial hospitalization program.

RUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individual receiving treatment at a local addiction treatment center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Recovery Unplugged

Fort Lauderdale, Florida, 33304, United States

RECRUITING

Recovery Unplugged

Lake Worth, Florida, 33461, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Madison Roopchand, MS

CONTACT

Christian DeLucia, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychology Trainee, MS

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

October 22, 2024

Primary Completion

October 22, 2025

Study Completion

January 1, 2026

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations