NCT03971097

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 5, 2021

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

May 4, 2019

Last Update Submit

September 3, 2021

Conditions

Keywords

Substance abuseAddictionOpiatesAlcoholCocaineBenzodiazepineHeroinSelf-forgivenessSelf-stigma

Outcome Measures

Primary Outcomes (2)

  • Substance Abuse Self-Stigma Scale (SASSS)

    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).

    14 days

  • Self-Forgiveness Dual Process Scale (SFDPS)

    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.

    14 days

Study Arms (2)

Control Group (TAU)

ACTIVE COMPARATOR

Participants of the study who will receive the normal programming schedule or treatment as usual (TAU).

Behavioral: Treatment as Usual (TAU)

Experimental Group (TAU plus self-forgiveness model)

EXPERIMENTAL

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-ForgivenessBehavioral: Treatment as Usual (TAU)

Interventions

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.

Experimental Group (TAU plus self-forgiveness model)

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.

Control Group (TAU)Experimental Group (TAU plus self-forgiveness model)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

Related Publications (3)

  • Griffin BJ, Worthington EL, Davis DE, Hook JN, Maguen S. Development of the Self-Forgiveness Dual-Process Scale. J Couns Psychol. 2018 Nov;65(6):715-726. doi: 10.1037/cou0000293.

    PMID: 30421952BACKGROUND
  • Luoma JB, Nobles RH, Drake CE, Hayes SC, O'Hair A, Fletcher L, Kohlenberg BS. Self-Stigma in Substance Abuse: Development of a New Measure. J Psychopathol Behav Assess. 2013 Jun 1;35(2):223-234. doi: 10.1007/s10862-012-9323-4.

    PMID: 23772099BACKGROUND
  • Worthington, E.L. (2013) Moving forward: Six steps to forgiving yourself and breaking free from the past. New York, NY: Waterbrook.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related DisordersAlcoholismCocaine-Related DisordersHeroin DependenceBehavior, Addictive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersAlcohol-Related DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Holly P Branthoover, EdD.

    Indiana University of Pennsylvania

    STUDY CHAIR
  • Michael P Verona, MA

    Indiana University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be made aware of their status in either the control group or experimental group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2019

First Posted

June 3, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 31, 2019

Last Updated

September 5, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

All information gathered, analyzed, and reported will be presented in aggregate form and exclude identifying characteristics.

Locations