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The Effect of Self-Forgiveness on Self-Stigma in Addiction.

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ClinicalTrials.gov Identifier: NCT03971097
Recruitment Status : Not yet recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Indiana University of Pennsylvania
Information provided by (Responsible Party):
Michael Verona, University of Pittsburgh

Brief Summary:
This study has an experimental design and will examine the difference in pre-test and post-test data on the Self-Forgiveness Dual Process Scale (SFDPS) (Griffin, Worthington, Davis, Hook, & Maguen, 2018) and the Substance Abuse Self-Stigma Scale (SASSS) (Luoma et al., 2013). Data will be collected from two groups of participants receiving counseling at the short-term rehabilitation facility located at University of Pittsburgh Medical Center's (UPMC). Individuals who agree to participate in the study will be randomly assigned to either the experimental group (EG) or the control group (CG). Data collected will include pre-test SFDPS and SASSS scores for the EG and the CG (collected within 24-hours of admission), and post-test SFDPS and SASSS scores for the EG and CG (collected after 14 days). ANCOVA will be used to analyze the pre-test and post-test data recorded from participants' scores.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Opiate Dependence Opiate Withdrawal Syndrome Opioid-use Disorder Alcohol Withdrawal Alcohol Abuse Alcohol Use Disorder Cocaine Abuse Cocaine Use Disorder Cocaine Withdrawal Benzodiazepine Abuse Benzodiazepine Dependence Substance Abuse Heroin Overdoses Heroin Withdrawal Heroin Abuse Behavioral: Six Step Model of Self-Forgiveness Behavioral: Treatment as Usual (TAU) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The purpose of this study is to examine differences between two groups of individuals receiving treatment at a residential drug and alcohol rehabilitation facility located at UPMC's McKeesport campus. The control group will receive treatment as usual (TAU) which includes group therapy, 12-step meetings facilitated by outside representatives of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA), medical care, and individual needs assessment with recommendations for aftercare. The experimental group will receive TAU plus six additional individual counseling sessions that include integration of a self-forgiveness model developed by Worthington (2013). Differences between the groups will be measured by analyzing pre-test and post-test data on the Self-Forgiveness Dual Process Scale (SFDPS) (Griffin, Worthington, Davis, Hook, & Maguen, 2018) and the Substance Abuse Self-Stigma Scale (SASSS) (Luoma et al., 2013).
Masking: Single (Participant)
Masking Description: Participants will not be made aware of their status in either the control group or experimental group.
Primary Purpose: Treatment
Official Title: The Effect of a Self-Forgiveness Model on Self-Stigma in Individuals Diagnosed With Substance Use Disorder.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group (TAU)
Participants of the study who will receive the normal programming schedule or treatment as usual (TAU).
Behavioral: Treatment as Usual (TAU)
Treatment as Usual (TAU) includes four group therapy sessions facilitated by the social services team (counselors and social workers), two 12-step meetings facilitated by outside representatives of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA), dietary, spirituality, medical care including vital signs and the administration of prescribed medication by the nursing staff, and individual needs assessment with a recommendation of appropriate aftercare.

Experimental: Experimental Group (TAU plus self-forgiveness model)
Participants of the study who will receive TAU plus six additional individual counseling sessions that include integration of a self-forgiveness model developed by Everett L. Worthington.
Behavioral: Six Step Model of Self-Forgiveness
The six-step model includes a workbook that applies Worthington's (2013) conceptualization of self-forgiveness and guides the practitioner and participant through the self-forgiveness process. Each step provides a framework for techniques and includes psychoeducation, interventions, and "homework" to be completed in between sessions. The individual sessions will not conflict with the timing or content of the unit's regular treatment schedule, thus, participation in the study will not affect a patient's ability to participate in TAU. All interventions will be done individually to ensure that participant confidentiality is respected throughout the therapeutic process.

Behavioral: Treatment as Usual (TAU)
Treatment as Usual (TAU) includes four group therapy sessions facilitated by the social services team (counselors and social workers), two 12-step meetings facilitated by outside representatives of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA), dietary, spirituality, medical care including vital signs and the administration of prescribed medication by the nursing staff, and individual needs assessment with a recommendation of appropriate aftercare.




Primary Outcome Measures :
  1. Substance Abuse Self-Stigma Scale (SASSS) [ Time Frame: 14 days ]
    Self-stigma can be defined as internalized stigma and is closely related to shame. The SASSS is a 40-item assessment (minimum total score is 40; maximum total score is 200) based on relational frame theory and is designed to measure self-stigma experienced by individuals who are misusing substances. It contains four discrete subscales and asks the participant to indicate on a 5-point Likert scale the frequency of thoughts/experiences, how much people would react to them, and the degree to which a true statement characterizes them. Higher scores reflect higher levels of self-stigma. The four subscales include self-devaluation (8 items; min score 8; max score 40), fear of enacted stigma (9 items; min score 9; max score 45), stigma avoidance (13 items; min score 13; max score 65), and values disengagement (10 items; min score 10; max score 50).

  2. Self-Forgiveness Dual Process Scale (SFDPS) [ Time Frame: 14 days ]
    The SFDPS is a 10-item assessment (minimum total score is 10; maximum score is 70) based on social cognitive theory and contains two subscales, values reorientation and esteem restoration. Responses are measured on a 7-point Likert scale ranging from strongly disagree to strongly agree. Higher scores reflect higher levels of self-forgiveness. The first five questions (5 items; min score 5; max score 35) focus on reorientation toward positive values and measure the cognitive shift toward accepting responsibility for one's perceived offense and committing to align future behavior with positive values. The second five questions (5 items; min score 7, max score 35) focus on restoring one's person sense of self-esteem and measure the extent to which one has replaced self-condemning emotions with self-affirming ones.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Admitted to the short-term rehabilitation program at UPMC McKeesport.
  • Have agreed to take part in research designed to examine the relationship between self-forgiveness and self-stigma in individuals with SUD.

Exclusion Criteria:

• Patients who previously took part in the study, were discharged, and then readmitted to the unit within six months due to relapse.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971097


Contacts
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Contact: Michael P Verona, MA 4126002252 ext 4126002252 m.p.verona@iup.edu
Contact: Richard P Harr, MSN 4126642036 ext 4126002252 harrrx2@upmc.edu

Locations
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United States, Pennsylvania
UPMC McKeesport Not yet recruiting
McKeesport, Pennsylvania, United States, 15132
Contact: Michael Verona, MA    412-664-2036    veronam2@upmc.edu   
Contact: Richard Harr, BSN    412-664-2052 ext 4126642036    harrrx2@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Indiana University of Pennsylvania
Investigators
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Study Chair: Holly P Branthoover, EdD. Indiana University of Pennsylvania
Principal Investigator: Michael P Verona, MA Indiana University of Pennsylvania

Publications:
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Responsible Party: Michael Verona, Doctoral Candidate, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03971097     History of Changes
Other Study ID Numbers: STUDY19030237
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All information gathered, analyzed, and reported will be presented in aggregate form and exclude identifying characteristics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Verona, University of Pittsburgh:
Substance abuse
Addiction
Opiates
Alcohol
Cocaine
Benzodiazepine
Heroin
Self-forgiveness
Self-stigma

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Alcoholism
Opioid-Related Disorders
Cocaine-Related Disorders
Substance Withdrawal Syndrome
Heroin Dependence
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders