Clinical trial NCT05018312: Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety
Official title: Social Phobia and Evasiveness: A Feasibility, Superiority, Randomized Clinical Trial of the Effect of Modified Collaborative Assessment VS Standard Assessment on Patient's Readiness For Psychotherapy (CO-ASSM-RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotherapy
Social Anxiety Disorder
Personality Disorders
Keywords: Therapeutic Assessment
Psychiatry
Person-centered
Mental Health Service
Pre-therapy
Collaborative Assessment
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
Collaborators: name: Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service
First posted: 2021-08-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Naturalistic, superiority trial
Primary purpose: TREATMENT

Brief summary: The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.

Detailed description: The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual (AAU) among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.

The study will include and randomise 42 patients 1:1 to either MCA or AAU, which will be administered as a pre-treatment to the standard psychotherapeutic intervention they will receive in the psychotherapeutic clinic.

MCA will utilize standardised psychological tests administered in collaboration with the patients, in order to thorough diagnose the included patients. The tests available will be the Present State Examination (PSE), the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD), the Screen for Cognitive Impairment in Psychiatry (SCIP), the Autism Diagnostic Observation Schedule (ADOS-2), the Examination of anomalous self-experience (EASE), the Wechsler Adult Intelligence Scale (WAIS-IV), the Level of Personality Functioning - Brief Form 2.0 (LPFS-BF), the Personality Inventory for DSM-5, 36 item version (PID-36) and the Conners´ Adult ADHD Rating Scales (CAARS).

Data are gathered through a number of questionnaires from patients prior to randomization (T0), at end of MCA (T1) and after four weeks of psychotherapy (T2) - absolute time depend on clinical logistics and timing of group therapy onset.

Eligibility criteria: Inclusion Criteria:

* A tentative ICD-10 diagnosis of either SAD or EPD
* Going to be offered treatment in the psychiatric community clinics in Naestved, Maribo or Slagelse

Exclusion Criteria:

* Severe physical health problems.
* Lack of spoken and written danish corresponding to 9th grade primary school.
* Eating disorder with BMI \< 18
* Psychotic illness
* Active diagnosis of substance abuse

Primary outcomes:
measure: University of Rhode Island Change Assessment Scale (URICA)
timeFrame: Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale-Self- Report (LSAS)
timeFrame: Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Other outcomes:
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
measure: General Self-Efficacy Scale (GSES)
timeFrame: Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
measure: Working Alliance Inventory (WAI)
timeFrame: T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
measure: National Patient Reported Outcome Measures (PROM)- Psychiatry
timeFrame: Baseline T0 (end of intervention, an average of four weeks after allocation); T1 (end of intervention) and T2 (after one month psychotherapy)
measure: Purpose-made questionary on specific feasibility-outcomes
timeFrame: T1 (end of intervention, an average of four weeks after allocation)
measure: Readiness for Psychotherapy Index
timeFrame: Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)
Locations:
city: Maribo
country: Denmark
facility: Psykiatrisk Klinik Maribo
state: Sjælland
city: Næstved
country: Denmark
facility: Psykiatrisk Klinik Næstved
state: Sjælland
Study officials:
affiliation: Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS
name: Sidse Arnfred, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References: