Clinical trial NCT03971097: The Effect of Self-Forgiveness on Self-Stigma in Addiction.
Official title: The Effect of a Self-Forgiveness Model on Self-Stigma in Individuals Diagnosed With Substance Use Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Substance abuse
Addiction
Opiates
Alcohol
Cocaine
Benzodiazepine
Heroin
Self-forgiveness
Self-stigma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Indiana University of Pennsylvania
First posted: 2019-06-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Detailed description: Participants of this study will consist of individuals 18 years of age or older, who have been admitted to the short-term rehabilitation program affiliated with UPMC and have agreed to take part in research designed to examine the relationship between self-forgiveness and self-stigma in individuals with SUD.

Patients will be made aware of the study by the principal investigator during an initial, in-person assessment that will occur within 48 hours of their admission to the unit. All patient rooms on this unit are limited to one patient which allows for privacy. Those who express interest, will be provided a copy of the Informed Consent Form and made aware of their right to decline participation or withdraw at any time, the limits of confidentiality, and that a lack of participation will not affect the level of care they receive. Patients who choose to participate in the study will be required to agree to the terms detailed in the consent form by signing and dating the form. Patients will then be assigned a participant number which be recorded on a link sheet only available to the principal investigator. Randomization software developed by GraphPad Software, Inc. will be used to randomly assign participants to either the experimental group or control group and that group assignment will be recorded on the link sheet. Participants will not be made aware of the group to which they have been assigned.

Prior to administering the SFPDS and SASSS to the participant, the principal investigator will write the corresponding participant number and group assignment on the top right-hand corner of the assessments. The participant will be asked to recall an event from their past that currently evokes feelings of regret. The participant will then be provided a copy of the SFDPS and SASSS. Because cultural and demographic factors such as level of education and physical disabilities are more common with this population, participants can choose to have the assessments administered orally. It is estimated that combined, the assessments will take 30 to 40 minutes to administer. To increase validity, participants will be informed that their answers will not be shared with other participants or members of the treatment team. Completed assessments will be collected and placed in an individual participant folder accessible only to the principal investigator. SFDPS and SASSS scores will be recorded on the link sheet in the pre-test columns.

Over the next 14 days, in addition to treatment as usual (TAU), participants in the experimental group will be introduced to techniques based on a six-step model of self-forgiveness during six individual sessions facilitated solely by the principal investigator. Participants in the control group will participate in the daily TAU schedule which 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. The six-step model includes a workbook that applies Worthington's 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. After the sixth session, participants will be administered the SFDPS and SASSS for a second time. Scores will be recorded on the link sheet in the post-test columns. Participants who were in the control group will be offered a copy of the self-forgiveness workbook and provided additional support if requested.

Power analysis was performed utilizing G\*Power 3.1, a stand-alone power analysis program for statistical tests used in the social, behavioral, and biomedical sciences. Using a desired power of .8 and a p-value of \<.05, it was determined that an appropriate sample size to detect a significant difference in pre-test and post-test scores on the SFDPS and SASSS between the experimental group and control group is N=128 participants. Thus, the selection process will be repeated until a minimum of 64 experimental group participants and a minimum of 64 control group participants have completed the study.

The email sent to the social services team, the nursing staff, and the unit supervisors at UPMC McKeesport will ensure that the appropriate staff members at the facility are aware of the purpose of this study, the details of the Informed Consent, the content being assessed, and the nature of the workbook. Participants will be encouraged to follow up with the principal investigator or a staff member if they experience any distressing emotions related to their participation in the study. Having these staff members aware of the study and available to participants to process any issues that may arise from their participation will serve as a protective factor and mitigate potential risks. Participation in the study is strictly voluntary and each participant reserves the right to withdraw from the study at any time. Participation or non-participation in this study will not impact participant status in the program in any way. Participants will be notified of the limits of confidentiality and the mandated reporting role of the principal investigator during the Informed Consent process. As the participants will be provided with a copy of the Informed Consent Form, they will be able to refer to this information on their own at any time.

The initial assessments, informed consent process, and workbook sessions will be conducted either in a private hospital room or a confidential group room setting to protect the privacy of study participants. The principal investigator's notes, scores from the SFDPS and SASSS, and answers from the workbook exercises (together referred to as "data") will be confidential and none of the information gathered during these meetings will be discussed or shared with staff members at the facility. Once the informed consent process is complete, participants will be assigned a number that will correspond to their data. The principal investigator will create a "link sheet" that will connect the participant's name (provided on the consent form) with the number on the notes, scoring sheets, and workbook. This sheet will only be seen by the principal investigator and will be destroyed upon completion of the study. As participants complete the study, their names will be removed from the link sheet. Prior to analysis of the data, no one apart from the principal investigator will have access to the data. All information gathered, analyzed, and reported will be presented in aggregate form so that no identifying characteristics can be made. Any data that is collected will be also be secured electronically via password and encryption or physically in a locked filing cabinet in a secured office.

There are no guaranteed benefits for participating in this study; however, participants may experience a reduction in the guilt, shame, and self-blame that often accompanies addiction.

Eligibility 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.

Primary outcomes:
measure: Substance Abuse Self-Stigma Scale (SASSS)
timeFrame: 14 days
measure: Self-Forgiveness Dual Process Scale (SFDPS)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
Study officials:
affiliation: Indiana University of Pennsylvania
name: Holly P Branthoover, EdD.
role: STUDY_CHAIR
affiliation: Indiana University of Pennsylvania
name: Michael P Verona, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Worthington, E.L. (2013) Moving forward: Six steps to forgiving yourself and breaking free from the past. New York, NY: Waterbrook.