Substance Use Treatment and Its Role in Supporting Social Cognition

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNova Southeastern University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Individual receiving treatment at a local addiction treatment center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment as Usual

    Behavioral

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

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: RUP1 intervention

Trial outcomes

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.

Time frame
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.

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

Other outcomes

1

Substance Use

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.

Time frame
Baseline and 2 months post treatment follow-up
2

Social Support

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." 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.

Time frame
Baseline and post treatment as well as 2 month post treatment follow-up
3

Therapeutic Alliance

The Working Alliance Inventory-Short Form (WAI-SF) is a 12-item self-report questionnaire used to assess the working alliance in therapy. The measure will be completed by both participants and therapists to evaluate their perceptions of the working relationship. The unit of measure for this outcome is the perceived strength of the working alliance, with responses rated on a 5-point Likert scale ranging from (1) "never" to (5) "always." For example, one item asks, "My therapist and I are working towards mutually agreed upon goals." The Working Alliance Inventory-Short Form consists of three subscales: (1) Goals (agreement on therapy goals), (2) Tasks (agreement on therapy tasks), and (3) Bond (the emotional connection between therapist and client). The WAI has demonstrated strong psychometric properties, including high internal consistency and good construct validity, making it a reliable tool for measuring the quality of the therapeutic alliance.

Time frame
Baseline, pre-discharge from residential and at PHP treatment pre-discharge
4

Report of therapist Emapthy

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." 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.

Time frame
Baseline, pre-discharge from residential , pre-discharge from PHP

Sponsors and contacts

Click on the lead sponsor to view all of their trials.