Social Phobia and Evasiveness: Trial Protocol for a Feasibility, Superiority, Randomized Controlled Trial of the Effect of Modied Collaborative Assessment vs. Standard Assessment on Patients’ Readiness for Psychotherapy (CO-ASSM-RCT).

: 21 Background: Evasive personality disorder (EPD) and social phobia (SP) have substantial costs to the 22 patients and their families, and great economic costs to the community. While psychotherapy can be an 23 efficient treatment, a large percentage of patients drop-out during treatment. Little is known about what 24 can be done in order to decrease dropout from psychotherapy in general, including how to increase a pa- 25 ti ent’s readiness for psychotherapy. Methods: We describe a feasibility randomized controlled trial of 42 individuals with a clinical diagno- 27 sis of either SP or evasive personality disorder, who are to initiate psychotherapeutic treatment in Dan- 28 ish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as- 29 usual and receive no further assessment, or to a Modified Collaborative Assessment (MCA) provided as 30 a pre-treatment intervention before psychotherapy initiation. MCA will included a battery of psycholog- 31 ical tests designed to thoroughly assess the patients’ psychopathology. The tests is administered in col- 32 laboration with the patient including a detailed oral and written feedback. We hypothesize that the pa- 33 tients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the 34 University of Rhode Island Change Assessment Scale (URICA) and have lower dropout-rates than as- 35 sessment-as-usual. 36 Discussion: This protocol assess the feasibility, efficacy, acceptability, and safety of an intervention 37 aimed at changing the readiness for participation in psychotherapy for patients with SP and EVP. Re- 38 sults from this feasibility study could guide the development of future large-scale trials of MCA and 39 procedures for MCA treatment fidelity assessment. 40


Methods:
We describe a feasibility randomized controlled trial of 42 individuals with a clinical diagno-27 sis of either SP or evasive personality disorder, who are to initiate psychotherapeutic treatment in Dan-28 ish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-29 usual and receive no further assessment, or to a Modified Collaborative Assessment (MCA) provided as 30 a pre-treatment intervention before psychotherapy initiation. MCA will included a battery of psycholog-31 ical tests designed to thoroughly assess the patients' psychopathology. The tests is administered in col-32 laboration with the patient including a detailed oral and written feedback. We hypothesize that the pa-33 tients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the 34 Danish outpatient mental health services provide time-restricted, standardized, interdisciplinary treat-81 ment programs for social phobia and AvPDs. Following national clinical practice guidelines, the treat-82 ment programs offer evidence-based cognitive-behavioral therapy for social phobia and mentalization-83 based therapy for AvPD. 84 The content and format in the standardized treatment programs for moderate-severe SP and AvPD are 85 regulated in accordance with the Danish Health Authority guidelines. The treatment program for SP 86 amounts up to 15 hours of clinical assessment (3hrs), psychopharmacological consultation (1 hrs), indi-87 vidual psychotherapy (7 hrs) or group therapy with two therapists (28 hrs), relatives support (1½ hrs), 88 and network consultation (1½ hrs) [17]. The standardized outpatient treatment program for AvPD in-89 clude 34 hours of clinical assessment (2 hrs), psychopharmacological consultation (2 hours) individual 90 therapy (11 hrs) or group psychotherapy with two therapists (60 hrs), and network consultation (3 hrs) 91 [18]. 92 Correspondingly, do the standardized outpatient treatment program for AvPD include 34 hours of clini-93 cian time, entailing approximately two hours of clinical assessment, two hour of psychopharmacological 94 consultation, 11 hours of individual therapy and 15 hours of group therapy with two therapists and lastly 95 three hours of contact with the general practitioner to other support-persons around the patient [18]. 96 However, despite a solid evidence-base for the efficacy of cognitive-behavioral therapy for social pho-97 bia, recent meta-analytic data suggest that only 45% of patients suffering from social phobia remit from 98 their principal diagnosis after treatment and patients with social phobia have a worse outcome than pa-99 tients with other anxiety disorders [19]. The evidence-base psychological treatment for avoidant person-100 ality is limited in terms of number and quality of studies and the remission rates vary substantially from 101 40-80% [20]. 102 Data from a recently finalized multicentre, randomized controlled trial [21] investigating the relative ef-103 ficacy of group diagnosis-specific versus transdiagnostic cognitive-behavioral therapy for anxiety disor-104 ders or depression support the meta-analytic findings on social phobia. In this trial, 291 patients with 105 anxiety disorders or depression received standardized treatment programs in three Danish mental health services, and the results suggested that only half of the patients no longer met diagnostic criteria for 107 their principal diagnosis by the end of treatment [22]. No data exists on the efficacy of the standardized 108 programs for AvPD. 109

Modified Collaborative Assessment 110
Psychiatric assessment do usually aim to establish a diagnosis and plan the treatment, while it is not 111 considered part of the treatment proper. We wish to alter this perspective by the introduction and explo-112 ration of a modification of Collaborative Assessment that we have chosen to name Modified Collabora-113 tive Assessment (MCA). 114 MCA takes off from Collaborative Assessment and Therapeutic Assessment (C/TA) [23][24][25]. These 115 terms are used to describe a family of semi-structured, brief, therapeutic interventions, in which a thera-116 pist with a large battery of standardized diagnostic and psychological tests, administer these in a collab-117 orative manner, and deliver feedback in a manner that is useful and enriching -and therefore therapeutic 118 -for the patient. 119 C/TA have been explored in several controlled trials with adults, and have been shown to be able to in-120 crease a range of process-variables related to therapy outcomes. This includes self-esteem [26][27][28][29] We wish to apply a modification of C/TA, where the intervention is shorter, and slightly more struc-127 tured and require less psychiatric expertise (i.e. can be carried out by trainee doctors and psychologists) 128 which we therefore expect to be more feasible in the trial as well as in later implementation. 129 MCA will, similar to C/TA, include the administration of standardized diagnostic instruments, but we 130 will in contrast to C/TA only include a smaller selection of tests, in order to secure feasibility. The bat-tery of tests will be specifically designed to gather information on psychopathology, which a brief clini-132 cal interview might not detect, such as symptoms of previously un-detected developmental disorder or 133 incipient psychosis. We have compiled a battery of tests with this focus because we find it most suitable 134 for application in the Mental Health Service. The present study is further designed to establish diagnosis 135 adhering to the current diagnostic systems (ICD-10 and DSM-5), but we expect it would be applicable if 136 the Mental Health Service introduce the dimensional [37, 38] model of psychopathology, since the cur-137 rent MCA also includes a thorough personality assessment according to the DSM-5 alternative model of 138 personality pathology.. 139 MCA emphasize respect for the patients as "experts on themselves." The accessor will in collaboration 140 with the patient formulate a list of therapeutic questions, which the patient would like to "ask the psy-141 chological test's" which will help guide the patient's and accessors collaborative quest to learn more 142 about the patient's problems and personal resources. The results of the assessment and the answer to the 143 therapeutic questions will be communicated, respectfully, to the patient both orally and in writing. It 144 will further be communicated to the patient's future therapist in writing. In this manner, it should be 145 possible to formulate personally relevant problems for the later psychotherapy. The MCA-accessor rec-146 ognizes that diagnostic assessments is an interpersonal event, and that the relationship between assessor 147 and patient is paramount both in relation to the validity of the result, and in relation to the patient's fur-148 ther treatment [25]. 149 In short, MCA is a brief, individualized, and person-centered assessment of psychopathology, where as-150 sessment, psychotherapy and psychoeducation are integrated in a novel intervention, all carried out in 151 collaboration with the patient. 152 153

Readiness for Psychotherapy 154
The fundamental role of patients' readiness to psychotherapy change (or client motivation) for outcome 155 of therapy is widely recognized [39]. The concept overall refers to the intentional aspect of change, the 156 internal drive preceding behavioral change before the initiation as well as the ongoing engagement throughout therapy [40]. Theoretically the concept is most profoundly described as a core component in 158 the 'stage of change'-dimension of the so-called Transtheoretical Model of behavior change set forward 159 by Prochaska & DiClemente [41]. In the 'stage of change'-dimension, patients are assumed to vary in 160 their overall readiness to change , and being on different levels of readiness to change ranging from 161 'pre-contemplation' over being ambivalent about change ('contemplation'), having intentions to change 162 ('preparation'), and starting changes ('action') to consolidating changes ('maintenance). 163 Studies have consistently found patients' readiness to change to be an important factor in predicting and 164 moderating psychotherapy outcomes for patients [42]. Regarding anxiety disorders, research indicate 165 that patients' readiness to change reduces symptoms and improve other process variables such as work-166 ing alliance and adherence to treatment [43]. However, data suggest that up to 80% of patients are not 167 ready for change (to pursue treatment goals) when they enter treatment and they harness ambivalence 168 about therapy [44]. 169 We expect that MCA will increase patient's readiness for psychotherapy as assessed by the University 170 of Rhode Island Change Assessment Scale (URICA) (contemplation subscale) and the Readiness for 171 Psychotherapy Index (RPI), and increase engagement in psychotherapy as measured by attendance to 172 psychotherapy. We expect that more than one mechanism of action is at play: (a) the patient will de-173 velop a relationship with the MCA-accessor and the outpatient clinic during the course of MCA, which 174 will carry-over to the therapeutic-relationship with the psychotherapist; (b) due to the structural MCA 175 format, the patient will be confident that her problems are seen and understood; (c) the patient will un-176 derstand herself and her problems and personal strengths, and will more effectively be able to work on 177 these in therapy, and (d) the therapists will have a greater knowledge of the patient's problems based on 178 the summaries from the MCA. 179

Objectives 180
The study objectives are to (1) compare the effect of MCA vs Assessment As Usual (AAU) in patients 181 referred to group therapy for social phobia or AVPD on levels of readiness for psychotherapy compared 182 with AAU at end-of-intervention (T1) (main outcome) and after one month follow-up (T2); (2) compare the effect of MCA vs AAU in patients referred to group therapy for social phobia or AVPD on diagno-184 ses (number of diagnostic revisions) and treatment offered (number of patients offered other or addi-185 tional treatment) as well as adherence to group therapy (adherence within the first four weeks); (3) ex-186 plore the feasibility of MCA as intervention through patient satisfaction ratings and patient and thera-187 pist/clinician evaluations; (4) and develop a fidelity-checklist for the MCA intervention. 188

Hypotheses 189
We hypothesize that that MCA in patients with social phobia or AvPD is superior to AAU in increasing 190 contemplation score (URICA, see below) at end of intervention (T1).
(2) In addition to this, patients of-191 fered MCA have higher service satisfaction ratings (CSQ) than AAU prior to psychotherapy onset and 192 user evaluation scores of MCA (purpose made) are positive (more than 3 on a 1-5 Likert Scale A CONSORT diagram is provided in Fig. 1. A diagram of the proposed study and the outcome-assess-199 ment is provided in Fig. 2. The trial data collection and randomization, stratified by gender, will be car-200 ried out in the web-based data management system REDcap (https://www.project-redcap.org/). Self-rat-201 ings will be collected on the web-based REDcap platform. 202 203 Version 1.4 October 13th, 2021. The setting of the study is Psychiatry South in Region Zealand, which is a rural-region with several me-207 dium-sized cities, according to Danish standards. Two of these cities have Psychiatric Outpatient Clin-208 ics, which carry out psychotherapeutic treatment of patients with emotional disorders, which are too se-209 rious to be manageable by family doctors and primary sector psychologist and psychiatrists. Patients are 210 typically referred by general practitioners, when they have failed to respond to one or two different 211 treatments (medication and/or psychotherapy). The services in these clinics are covered by the public Danish health insurance, and involve both psychotherapy and psychopharmacological treatment, see 213 also Introduction. 214

Participants and eligibility criteria 215
We aim to include 42 patients that satisfy the inclusion criteria: (1) a tentative ICD-10 diagnosis of ei-216 ther SP or AVPD, (2) who is going to be offered treatment in the before mentioned clinics, (3) are 18-65 217 years of age, (4) have given written consent to participate and (5)  If patients are eligible for treatment in the clinic, they will be provided with information about the pro-226 ject and they will be invited to a meeting with a researcher, where the informed signed consent is gath-227 ered 228

Randomization and blinding 229
Patients will be randomized 1:1 to either the MCA or AAU. Allocation to experimental intervention or 230 comparison intervention will be computer-generated using the software REDCap © [45]. 231 Due to the nature of the intervention, neither participants nor the researcher who will administer the in-232 tervention, can be blinded to allocation. However, data will be re-coded for concealment and analyzed 233 without access to information about allocation. The conclusion will be written prior to unblinding. 234

Experimental intervention 235
The MCA, as described in the Introduction will include at least the administration of the following nine 236 assessment instruments: Present State Examination (PSE). PSE is a semi-structured interview that intends to provide an objec-238 tive evaluation of symptoms associated with mental disorders. It consists of 140 items, which is scored 239 on a 3-point or 4-point scale [46]  Patients allocated to the control-group will receive AAU, which is the standard assessment patients will 277 receive in the clinic, administered in the manner the assessment usually is. Standard assessment could 278 include diagnostic assessment with structured interviews (i.e. SCID-5 or PSE) if found indicated by the 279 clinical assessment team. 280

Intervention fidelity 281
The intervention will be carried out by the researcher, a resident in psychiatry. He will receive training 282 and supervision on the assessment battery from experts in the field, and he will likewise receive training 283 and supervision in Therapeutic Assessment. Audio or video-recordings of MCA consultations will be 284 used for supervision purpose, and to secure intervention fidelity. 285

286
Data are gathered through a number of questionnaires from patients prior to randomization (T0), at end 287 of MCA (T1) and after four weeks of psychotherapy (T2)absolute time depend on clinical logistics and timing of group therapy onset. 289 An overview of outcome measures is given in Table 1, and instruments in each category are detailed be-290 low. 291

Primary outcome (objective 1) 292
University of Rhode Island Change Assessment Scale (URICA). URICA is a 32-item self-report 293 measure that including 4 subscales designed to quantify the patients motivation for change: The four 294 subscales are Pre-contemplation, Contemplation, Action, and Maintenance [55]. We will utilize Con-295 templation score as our primary outcome. 296 297

Secondary outcomes 298
The Liebowitz Social Anxiety Scale-Self-Report (LSAS). The self-administered 24-item LSAS-299 SR[55], which is highly correlated with the clinician-administered version [56] includes questions per-300 taining to social interaction and performance situations. The LSAS-SR have shown to have good con-301 vergent, discriminant validity, and reliability [57]. 302 Rosenberg Self-Esteem Scale (RSES). The RSES is a 10-item measure of self-esteem that includes 303 five positive items and five negative items which are reversed scored [58]. In general, the RSES has 304 demonstrated good convergent validity and good test-retest reliability and in similar populations of 305 adults with social phobia, the RSES has demonstrated high internal consistency [59]. 306 General Self-Efficacy Scale (GSES). The GSES is a 10-item psychometric scale that is designed to as-307 sess optimistic self-beliefs to cope with a variety of difficult demands in life. In contrast to other scales 308 that were designed to assess optimism, this one explicitly refers to personal agency, i.e., the belief that 309 one's actions are responsible for successful outcomes [60,61]. 310

Exploratory Outcomes 312
Working Alliance Inventory (WAI). The WAI is a 36-item self-report psychometric scale that is de-313 signed to a assess the therapeutic alliance between a patient and a therapist [62]. It will access the work-314 ing alliance between the group-therapists and the patients. 315 Readiness for Psychotherapy Index. The RPI is a 42-item self-report measure that uses a 5-point Lik-316 ert scale to assess 7 dimensions of readiness for psychotherapy: level of distress, desire for change, 317 willingness to work in therapy, recognition of problems as psychological, willingness to discuss per-318 sonal matters, willingness to endure discomfort in therapy, and responsibility for change [63]. The ques-319 tionnaire will be translated and validated for use in a Danish mental health service population, as part of 320 the present study. Evaluation of the intervention (EQ). Questionnaire focusing on the patient's and therapist's evalua-332 tion of the intervention, which is purpose-made for the current study, will be distributed at the end of the 333 intervention. Items will be constructed as Likert Scale feedback forms consisting of a list of statements 334 about different aspects of the course of the intervention. Response possibilities are five categories rang-335 ing from very much in agreement to not at all.

Adverse effects 337
We monitor for adverse events, in particular suicidal behavior/ideation and will check for this at every 338 visit to the clinic. If a patients is admitted during participation in the study, a senior consultant will de-339 cide whether the patient can continue to participate in the present study. 340

Patient and public involvement 344
We will throughout the present trial seek the feedback of users and next-of-kin, and we will establish a 345 user-panel who will help interpret the findings of the study. 346

Statistical considerations 347
Sample size calculation is based on figures in Dozois et al. (2004) [67] of patients with panic anxiety, 348 where the primary outcome "Contemplation stage score" in readiness for change. It was mean 37,3 (SD 1,9) for CBT responders and mean 34,4 (std 3,4) for non-responders, i.e. with significance level 5% and 350 power 90%, it yields a total sample of 36 and 18 patients in each arm. We strive for 42 patients to ac-351 count for attrition around 15%. We find it feasible to include the 42 patients since 64 patients annually 352 are offered treatment packages (40 SP and 24 AVPD). A detailed statistical analysis plan will be pub-353 lished prior to data processing initiation. Briefly, we expect to analyze continuous outcomes by linear 354 regression. Categorical outcomes will be analyzed using chi-square testing of frequency distribution. 355 We will use multiple imputations to handle missing data. 356

Dissemination policy 357
The results of the present study will be disseminated by the Research Unit for Psychotherapy and Psy-358 chopathology's social media account and website. It will also be sought published through high-impact 359 international peer-reviewed journals, and be presented at conferences for clinicians, commissioners, and 360 researchers working in the mental health field. Both negative and positive findings will be published. 361 The protocol is published at clinicaltrials.gov (Nr 2021001). Although steps will be taken to avoid it, 362 protocol deviations may happen. Protocol deviations that occur after the start of trial recruitment will be 363 communicated at https://clinicaltrials.gov and detailed in publications. 364

Trial Status 365
The trial is expected to begin recruitment October 2021. The last participant is expected to be included 366 November 2022. The interventions session are expected to run from September 2021 to January 2023. 367

Discussion 368
The current study will be the first RCT investigating MCA in a Mental Health Services setting. It will 369 be a feasibility study, and will test the study hypothesis in a small clinical sample. If the present study is 370 successful, it might be followed up by other and larger clinical studies on MCA. The study will contrib-371 ute to sparse existing research concerning the impact of clinical assessment and will provide important 372 new knowledge about the effect of routine and systematic patient-centered clinical assessment and gen-373 erate effect size measures for future power calculations. It will also generate data regarding patients readiness for psychotherapy, and the percentage of patients who are wrongly-diagnosed in a prototypical 375 Danish public healthcare psychotherapeutic clinic. 376 We believe the intervention will have a positive effect on the included patients, but there is however a 377 potential risk that the patients receiving MCA may not benefit from the excess assessment, but that the 378 treatment instead will increase dropout due to the patient becoming overwhelmed. There is also a possi-379 ble risk of the patients become upset or disappointed due to the new knowledge, they receive about 380 themselves. Ultimately, the MCA might yield an unexpected diagnosis which could severely change the 381 way the patient sees herself, and the way society in general sees the patient. Many of these problems, 382 may, however, also occur in AAU. 383 If the current project document feasibility of the approach, further studies should examine the incremen-384 tal value of MCA as to patient outcome of total treatment course, persistence in and length of treatment 385 and cost-effectiveness. 386 By the end of the present project, we will be able to decide whether the results are sufficiently promis-387 ing to pursue a full trial (phase III) [68]. For that purpose, the study output also encompass development 388 of a MCA protocol for clinicians and adjoining fidelity instrument. All participants will give written informed consent following the National Danish Ethics Committee's 399 guidelines, and do so prior to randomization and intervention allocation. 400

Consent for publication 401
Not applicable. 402

Availability of data and materials: 403
The datasets generated by the planned study will not be publicly available due to the rules of the Danish 404 Data Protection Agency, but will be available from the corresponding author, after publication, on rea-405 sonable request and following signed confidentiality agreement with PI and the Danish Data Protection 406