Patient Engagement in PTSD Treatment (PEP)

INTRODUCTION Traumatic events are a common experience worldwide. Data from the World Mental Health Consortium indicate that 70% of the general population reports at least one traumatic event, with 30.5% reporting four or more events. Certain populations, such as refugees and individuals in trauma-exposed professions (e.g., police officers, paramedics, and military personnel), are at heightened risk of encountering traumatic experiences. While the majority of individuals exposed to trauma do not develop long-term psychological distress, a significant subset develops posttraumatic stress disorder (PTSD), the primary mental health condition associated with trauma. According to the 2017 WHO World Mental Health Survey, 5.6% of trauma-exposed individuals develop PTSD, with half of these cases being persistent. PTSD is among the leading health-related causes of functional impairment, including days out of role.

Despite existing evidence-based interventions for PTSD, one-third of those undergoing treatment are non-responders and one-third drop out. This poses significant economic and social costs to the patient and to society. Previous randomized trials on refugees with PTSD at the CTP have pointed to motivation and cognitive resources as key predictors of treatment outcome. Others have theorized, and shown, that using standardized shared decision-making tools can enhance patient engagement in evidence-based PTSD treatment. Understanding the prerequisites of patients, such as motivational readiness and cognitive resources, are important in guiding decisions about treatment. At best, assigning homework or providing ambitious psychoeducation is a vain effort if the patient does not possess the motivation or cognitive means to engage, comply or fully understand. At worst, it demotivates and adds to the patient's sense of inadequacy.

These theories and hypotheses point to the need to gauge motivation, patient preference and values and assess cognition at the outset of treatment properly and to assess how to adapt treatment to fit each patient individually.

The overall aim of the PEP study is to improve the outcome of outpatient PTSD treatment.

1. To test the added value of the introductory PTSD module as a precursor of PTSD treatment in two RCTs. It is hypothesized that promoting patient engagement and motivation for treatment will increase treatment outcomes and reduce dropout relative to TAU. 2. To test the value of SDM to facilitate individualized treatment for the diverse population of refugees. This aim is specific to the CTP-trial. It is hypothesized that SDM + IPM will yield a superior outcome to TAU + IPM based on optimal utilization of resources of patients and clinicians. 3. To compare cognitive deficits in Danish civilians and trauma-affected refugees with PTSD, examining influences of emotional distress, demographic and socio-economic factors on test performance and to determine the predictive value of cognitive tests on treatment outcomes. 4. To study the association between motivation and severity of mental health symptoms, quality of life and functioning at baseline 5. To explore what patients and clinicians find useful and valuable about the introductory PTSD module add-on and SDM, and determine how these two components can influence treatment readiness and patient engagement 6. To examine the effect of treatment at six months follow-up on overall PTSD symptoms Course of treatment and data collection will follow the SPIRIT statement.

PATIENT RECRUITMENT Patients can be referred to the clinics by any MD, most often their general practitioner (GP), a private practicing psychiatrist or an MD from a mental health or somatic hospital. A senior psychiatrist at PU and CTP respectively assesses all referrals, and based on the referral, patients are invited for an initial assessment by a psychologist or MD at PU or an MD at CTP. At both clinics, if it is clear from the referral that the patient does not belong to the clinic's target group (i.e., does not present with trauma or any PTSD symptoms), the patient is not invited for an assessment.

Previous randomized trials at the CTP have included about 150 patients per year, and the fifth project) included 100 patients per year. The most recent study included 50 patients per year, but had significantly more restrictive inclusion criteria compared to the present study. In all trials 75-80 % of the patients have completed the project. No previous RCTs have been conducted at the PU, but it is estimated receiving 240 annual referrals for patients meeting the inclusion criteria.

Therefore, inclusion of 171 and 256 project participants, respectively, are deemed realistic within the given time frame.

INITIAL ASSESSMENT INITIAL ASSESSMENT AT PU The initial assessment is scheduled for all patients that are assessed to be in the target group as described above. The content of the assessment is not specific for this trial but applies to all initial assessments at PU, and no initiatives solely related to the trial will be performed during the initial assessment. The initial assessment at PU of the trauma-affected civilians is planned as 1-2 sessions (1-2 hours) and carried out by a member of the PTSD team. The team consists of authorized psychologists, unauthorized psychologists, psychologists with specialty in psychiatry and MDs. The assessment consists of a record of the trauma history, the main problem as seen by the patient, dispositions, social situation, somatic and psychiatric medical history, as well as a clinical and diagnostic assessment.

Standardized diagnostic tools such as part of Schedules for Clinical Assessment in Neuro-psychiatry (SCAN), International Trauma Interview (ITI) (80), and the ICD-10 research criteria will be applied in the interview. Various instruments of symptom severity and functioning are completed. After the initial assessment, the clinician presents the patient at a PTSD team conference. The team then collectively decides if the patient is eligible for treatment. To be eligible for treatment the patient must meet the criteria for PTSD and not have a psychotic disorder. The patient must be able to attend treatment, not be in current danger, and no longer be in the life situation that caused their PTSD. The patient should not be engaging in substance abuse or self-harm to a significant extent, and any other mental disorder must be well-managed enough for the patient to participate in trauma treatment.

Oral and written information about the treatment and the trial is given. If the patient fulfils eligibility criteria and consents to participate, the patient will be randomized after the initial assessment at PU.

INITIAL ASSESSMENT AT CTP The initial assessment is scheduled for all patients that are assessed to be in the target group of CTP as described above. The content of the assessment is not specific for this trial but applies to all initial assessments at CTP, and no initiatives solely related to the trial will be performed during the initial assessment. The initial assessment is planned as 2-4 sessions of approximately 45 minutes with an MD, resulting in a total of about two-three hours assessment and consists of: recording of the trauma history, the migration process, social situation, somatic and psychiatric medical history, as well as a clinical and diagnostic assessment. Standardized diagnostic tools such as part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN), International Trauma Interview (ITI) (80), and the ICD-10 research criteria will be applied in the interview. Various instruments of symptom severity and functioning are completed.

Oral and written information about the treatment and the trial is given. If the patient fulfils eligibility criteria and consents to participate, the patient will be randomized after the initial assessment at CTP.

RANDOMISATION All patients will be randomized after a total of two to three-hour initial assessment with an MD or psychologist in accordance with inclusion and exclusion criteria. An equal number of patients are randomized into the trial arms of the two RCT's (total number of patients at PU is 171, and total number of patients at CTP is 256). The actual randomization is carried out in REDCap (Research Electronic Data Capture).

BLINDING Blinding patients and practitioners are not assessed to be appropriate due to the different nature of the treatment interventions. However, a blinded Hamilton (depression) rating, WHODAS 2.0 12-item, and WHODAS subscale on cognition will be carried out at the beginning and at the end of treatment. The group of raters, consisting of medical students, will be trained at CTP and will take part in regular joint ratings to ensure high quality and interrater reliability. Data assessment and data analysis will be performed blinded.

REPRESENTATIVITY Patients have not been selected based on more specific criteria than elsewhere in the treatment system and are therefore representative for the population at other clinics treating trauma-related mental health problems in an ethnic Danish and refugee population. The results can thus be generalized to other corresponding patient groups and are directly applicable in the planning of treatment for trauma-affected populations seeking outpatient treatment.

TRIAL FIDELITY To determine trial fidelity, patient attendance will be registered and after each consultation with a MD, psychologist, nurse or social counsellor, the topics addressed will be registered, as well as the methods used during the consultation and whether the patient has completed their exercises between sessions as planned. It will be registered whether the main content of the consultation was of social, psychological, or somatic character. At each consultation with an MD any changes in medication will also be recorded.

If patient IPM sessions or SDM session are cancelled a rescheduling will be attempted, but this may cause variation in timing of sessions in the treatment course. This will be registered. The use of the Problem Identification Form at sessions throughout the treatment is also registered.

VARIABILITY IN THE COURSE OF TREATMENT All patients will follow the treatment described above as accurate as possible, but due to the pragmatic nature of the study there will possibly be some variation in attendance and timing of meetings and sessions, as the patients may become ill or for some other reason do not show up for sessions or meetings.

FREQUENCY OF RATINGS Patients will be asked to complete self-ratings several times during treatment: at the diagnostic interview/assessment, and at the end of the treatment course. If more than one month passes between the diagnostic interview/assessment and the start of the IPM intervention or TAU for the control group, the patients will be asked to complete the self-ratings scales again. Furthermore, at 1) transition between IPM intervention and TAU/individualized treatment in the intervention groups or 2) after four sessions in the control groups the RPI will be completed.

Observer ratings including blinded Hamilton ratings will take place at the beginning and end of treatment, and PI administered at the first and fourth IPM session (intervention groups) or first and fourth session in TAU (control groups). Furthermore, at the beginning of TAU or the individualized treatment PGOMs will be completed.

In addition, some of the ratings will also be carried out at follow-up six months after end of treatment.

DATA COLLECTION Data will only be collected at PU and CTP. After each session the clinicians will fill out the case report form (CRF) in the research database through REDCap (Research Electronic Data Capture). All ratings will be carried out by a PU or CTP practitioner (MD, psychologist, nurse or social counsellor). Blinded observer-rated interviews of Hamilton D6, WHODAS 2.0 short version (level of cognition) and WHODAS 2.0 short version (level of

• Readiness of Psychotherapy Index (RPI) [Срок оценки: Change from baseline to after intervention after approximately 1,5 months]
• Hopkins Symptom Check List-25 (HSCL) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• Psychological Outcome Profiles questionnaire (PSYCHLOPS) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• World Health Organisation - 5 Well-being Index (WHO-5) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• Life Events Checklist for DSM-5 (LEC-5) [Срок оценки: Administered once at the initial assessment]
• Post-migration Living Difficulties Check List (PMLD) [Срок оценки: Administered once at the initial assessment, but only at CTP]
• The 9-item Shared Decision Making questionnaire (SDM-Q-9) [Срок оценки: Administered once during treatment at the shared decision-making session only at CTP]
• The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• The World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognition [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• Hamilton depression scale (HAM-D6) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]
• Global Assessment of Functioning - Symptoms (GAF-S) [Срок оценки: Time Frame: Change from baseline to end-of-treatment after approximately 10 months]
• Global Assessment of Functioning - Functioning (GAF-F) [Срок оценки: Change from baseline to end-of-treatment after approximately 10 months]