Substance Use DisordersNCT03971097
The Effect of Self-Forgiveness on Self-Stigma in Addiction.
A study testing Six Step Model of Self-Forgiveness and Treatment as Usual (TAU) in people with Substance Use Disorders and Opiate Dependence, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Opiate Dependence, Opiate Withdrawal Syndrome
- What is being tested?
- Six Step Model of Self-Forgiveness and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who previously took part in the study, were discharged, and then readmitted to the unit within six months due to relapse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Self-Forgiveness Model on Self-Stigma in Individuals Diagnosed With Substance Use Disorder.
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.
Read the 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.
- Conditions
- Substance Use Disorders, Opiate Dependence, Opiate Withdrawal Syndrome, Opioid-use Disorder, Alcohol Withdrawal, Alcohol Abuse
- Being tested
- Six Step Model of Self-Forgiveness, Treatment as Usual (TAU)
- Keywords
- Substance abuse, Addiction, Opiates, Alcohol, Cocaine, Benzodiazepine, Heroin, Self-forgiveness, Self-stigma
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Alcoholism, Cocaine-Related Disorders, Heroin Dependence, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six Step Model of Self-ForgivenessBehavioural
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.
Treatment as Usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (TAU) | Active comparator | Participants of the study who will receive the normal programming schedule or treatment as usual (TAU). Receives: 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. Receives: Behavioral: Six Step Model of Self-Forgiveness; Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Holly P Branthoover, EdD., Study chair, Indiana University of PennsylvaniaMichael P Verona, MA, Principal investigator, Indiana University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971097
- Sponsor's protocol ID
- STUDY19030237
- Status last verified
- Jan 2020
- First submitted
- 4 May 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information gathered, analyzed, and reported will be presented in aggregate form and exclude identifying characteristics.
Publications
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.
PubMed 30421952Luoma 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.
PubMed 23772099Worthington, E.L. (2013) Moving forward: Six steps to forgiving yourself and breaking free from the past. New York, NY: Waterbrook.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Self-Forgiveness Model on Self-Stigma in Individuals Diagnosed With Substance Use Disorder.
- ClinicalTrials.gov ID
- NCT03971097
- Acronym / sponsor ID
- STUDY19030237
- Conditions
- Substance Use Disorders, Opiate Dependence, Opiate Withdrawal Syndrome, Opioid-use Disorder, Alcohol Withdrawal, Alcohol Abuse
- Keywords
- Substance abuse, Addiction, Opiates, Alcohol, Cocaine, Benzodiazepine, Heroin, Self-forgiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Indiana University of Pennsylvania
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control Group (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Participants of the study who will receive the normal programming schedule or treatment as usual (TAU). |
| Experimental Group (TAU plus self-forgiveness model) | Experimental | Behavioral: Six Step Model of Self-Forgiveness, Behavioral: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who previously took part in the study, were discharged, and then readmitted to the unit within six months due to relapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six Step Model of Self-ForgivenessThe 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. | Behavioural | Experimental Group (TAU plus self-forgiveness model) |
| 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. | Behavioural | Control Group (TAU), Experimental Group (TAU plus self-forgiveness model) |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 30421952Griffin 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.
- Background: PubMed 23772099Luoma 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.
- BackgroundWorthington, E.L. (2013) Moving forward: Six steps to forgiving yourself and breaking free from the past. New York, NY: Waterbrook.
- Individual participant dataSharing planned: No. All information gathered, analyzed, and reported will be presented in aggregate form and exclude identifying characteristics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly P Branthoover, EdD. study chair
Indiana University of Pennsylvania
Michael P Verona, MA principal investigator
Indiana University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six Step Model of Self-Forgiveness and Treatment as Usual (TAU) in people with Substance Use Disorders and Opiate Dependence, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Abuse Self-Stigma Scale (SASSS) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03971097, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.