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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH118319 | U.S. NIH Grant/Contract | View source | |
| A538900 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Study examining the feasibility of and psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.
Overall Study Objectives:
The primary objectives of this project include:
Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.
Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.
Eligible participants will first complete the Clinician-Administered PTSD Scale for DSM-5 (PCL-5) to ascertain current PTSD symptomology and diagnosis. Participants will then be assigned to the CPT groups. The CPT groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 6 participants will be included in each CPT session. Participants will be notified via institutional mail when they are starting CPT. Participants will be able to continue any ongoing treatment/interventions they are engaged in within the institution. All participants will be asked what treatment groups they are currently enrolled in during the initial screening to examine the possibility of attentional bias within the CPT group (i.e., more frequent interaction leading to treatment outcomes).
In addition to the treatment groups, CPT group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. After treatment session 5, group members will complete mid-testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT group members will then complete post-treatment testing within one week after completing treatment (group session 12). One month after the treatment is completed, group members will complete the first round of follow-up testing. Three months after the treatment is completed, group members will complete the final round of follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. The three month follow-up session will be identical, with the addition of the PCL-5 interview to re-assess PTSD diagnosis. Group members will be asked to complete 18 sessions in total (pre-, mid-, post-, one-month follow-up testing, three month follow-up testing, 12 treatment groups, and 1 post-intervention focus group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Processing Therapy (CPT) group | Experimental | Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) receive CPT to treat PTSD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy | Behavioral | CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | Intervention feasibility measured primarily by participant retention | up to 6 weeks (by the end of 12th session) |
| Change in Self-reported PTSD Symptoms (PCL-5) | PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period. | baseline (one week prior to intervention), post-intervention (up to 13 weeks on study) |
| Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | Post (1 week post-intervention, up to 13 weeks on study) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Individuals That Meet Study Inclusion Criteria | Assesses for participant eligibility as secondary measure of intervention feasibility. | baseline (one week prior to intervention) |
| Percentage of Eligible Individuals Enrolled in the Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Koenigs, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Institute and Clinic | Madison | Wisconsin | 53719 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | James, D.J. and L.E. Glaze, Mental health problems of prison and jail inmates, U.S.D.o. Justice, Editor. 2006: Bureau of Justice Statistics Special Report. | ||
| 25757522 | Background | Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209. | |
| 25697197 |
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89 participants were consented, 79 were deemed eligible, 69 started group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Women's Facility Cognitive Processing Therapy (CPT) | Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. |
| FG001 | Men's Facility Cognitive Processing Therapy (CPT) | Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Women's Facility Cognitive Processing Therapy (CPT) Group | Arm = Cognitive Processing Therapy (CPT) Group = Women's Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions | Intervention feasibility measured primarily by participant retention | Posted | Count of Participants | Participants | up to 6 weeks (by the end of 12th session) |
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Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women's Facility Cognitive Processing Therapy (CPT) | Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Passive Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Koenigs | University of Wisconsin Madison - Incarceration and Mental Health Lab | (608) 263-1679 | mrkoenigs@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 22, 2025 | Feb 26, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Participants are assigned to CPT therapy-intervention group.
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Assesses for participant interest as secondary measure of intervention feasibility.
| up to start of intervention |
| Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | Assesses for participant compliance: participation during session as secondary measure of intervention feasibility. | By the end of final treatment session (up to 12 weeks) |
| Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | Assesses for participant compliance: extent to which participants complied with treatment skill practice | By the end of final treatment session (up to 12 weeks) |
| Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor | Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated. | By the end of final treatment session (up to 12 weeks) |
| Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility. | By the end of final treatment session (up to 12 weeks) |
| Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility. | post (one week post-intervention, up to 13 weeks on study) |
| Reasons for Participant Discontinuation | We will collect information on participant dropout reasons to understand reasons for discontinuation | Up to 3 month follow up (up to 25 weeks) |
| Background |
| Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20. |
| Background | Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press. |
| 12182270 | Background | Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867. |
| 12150085 | Background | Morgan RD, Winterowd CL. Interpersonal process-oriented group psychotherapy with offender populations. Int J Offender Ther Comp Criminol. 2002 Aug;46(4):466-82. doi: 10.1177/0306624X02464008. |
| Left Facility |
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| BG001 | Men's Facility Cognitive Processing Therapy (CPT) | Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Race was measured by facility (men & women) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PCL-5 | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy | Mean | Standard Deviation | units on a scale |
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| Beck Anxiety Inventory (BAI) | Anxiety level measured by score on BAI (between 0 to 63, over 30 = severe anxiety); to characterize our baseline sample of participants | Mean | Standard Deviation | score on a scale |
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| Beck Depression Inventory 2 (BDI-II) | Depression level measured by score on BDI-II (between 0 to 63, over 40 = severe depression); to characterize the baseline sample of participants | Mean | Standard Deviation | score on a scale |
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Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. |
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| Primary | Change in Self-reported PTSD Symptoms (PCL-5) | PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period. | Participants with baseline and post-intervention data - the negative numbers indicate a decrease in symptom severity of the intervention period. | Posted | Mean | Full Range | score on a scale | baseline (one week prior to intervention), post-intervention (up to 13 weeks on study) |
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| Primary | Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) | Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | Participants lost to follow up | Posted | Mean | Standard Deviation | units on a scale | Post (1 week post-intervention, up to 13 weeks on study) |
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| Secondary | Percentage of Individuals That Meet Study Inclusion Criteria | Assesses for participant eligibility as secondary measure of intervention feasibility. | Screened participants (one week prior to intervention) | Posted | Count of Participants | Participants | baseline (one week prior to intervention) |
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| Secondary | Percentage of Eligible Individuals Enrolled in the Study | Assesses for participant interest as secondary measure of intervention feasibility. | Eligible participants | Posted | Count of Participants | Participants | up to start of intervention |
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| Secondary | Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) | Assesses for participant compliance: participation during session as secondary measure of intervention feasibility. | Posted | Count of Participants | Participants | By the end of final treatment session (up to 12 weeks) |
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| Secondary | Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets | Assesses for participant compliance: extent to which participants complied with treatment skill practice | Retained participants (up to 12 weeks on study) | Posted | Count of Participants | Participants | By the end of final treatment session (up to 12 weeks) |
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| Secondary | Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor | Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated. | CPT session elements | Posted | Number | Percentage of session elements present | By the end of final treatment session (up to 12 weeks) | CPT session elements | CPT session elements |
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| Secondary | Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist | Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility. | Both unique and non-unique but essential items were analyzed. Unique Items = therapeutic tasks specific to delivery of CPT; Essential Items = therapeutic tasks not specific to CPT but essential to the therapeutic process | Posted | Mean | Standard Deviation | CPT session elements | By the end of final treatment session (up to 12 weeks) | CPT session elements | CPT session elements |
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| Secondary | Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) | Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility. | Posted | Count of Participants | Participants | post (one week post-intervention, up to 13 weeks on study) |
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| Secondary | Reasons for Participant Discontinuation | We will collect information on participant dropout reasons to understand reasons for discontinuation | Posted | Count of Participants | Participants | Up to 3 month follow up (up to 25 weeks) |
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| 0 |
| 35 |
| 0 |
| 35 |
| 7 |
| 35 |
| EG001 | Men's Facility Cognitive Processing Therapy (CPT) | Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. | 0 | 34 | 0 | 34 | 14 | 34 |
| Increased PTSD symptoms | Psychiatric disorders | Non-systematic Assessment | Nightmares, Increase in PTSD symptom on PCL-5 |
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| Increase in depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Segregated Housing Placement / Rule Violation | Social circumstances | Non-systematic Assessment |
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| Medical Event | Cardiac disorders | Non-systematic Assessment | Hip issue requiring crutches, carpal tunnel syndrome, nerve pain in neck, dizziness and fainting due to existing condition, bedrest for unknown illness, infected finger |
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| Increased emotional distress | Psychiatric disorders | Non-systematic Assessment |
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| Social Circusmtances | Social circumstances | Non-systematic Assessment | Family member assaulted, argument with peer, kicked out of school, legal issues |
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| Group "Not Helpful" |
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| Work |
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| Withdrawn by study clinician |
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