Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety

Not Applicable

Active, not recruiting

• Conditions: Social Anxiety Disorder; Personality Disorders; Psychotherapy
• Interventions: Behavioral: Modified Collaborative Assessment (MCA); Behavioral: Assessment as Usual (AAU)

• Registration Number: NCT05018312
• Lead Sponsor: Psychiatric Research Unit, Region Zealand, Denmark

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.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-24
• Study Start: 2021-09-01
• Primary Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Collaborative Assessment (MCA)	Modified Collaborative Assessment (MCA)	The patients allocated to this arm will receive assessment inspired by therapeutic/collaborative assessment, as a pre-treatment to the standard psychotherapeutic treatment they will receive in the clinic.
Assessment as usual (AAU)	Assessment as Usual (AAU)	The patients allocated to this arm will receive standard assessment offered in the clinic, before proceeding to the standard psychotherapeutic treatment they will receive in the clinic.

Primary Outcome Measures

Name	Time	Method
University of Rhode Island Change Assessment Scale (URICA)	Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)	The URICA is a 32-item self-report measure that includes 4 subscales measuring the motivation for change: Precontemplation, Contemplation, Action, and Maintenance. The minimum score is 32 and maximum value is 160. A higher score indicate that the patient is more ready to making changes in their life, compared to a lower.

Secondary Outcome Measures

Name	Time	Method
Liebowitz Social Anxiety Scale-Self- Report (LSAS)	Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)	The 24-item LSAS-SR, includes questions pertaining to social interaction and performance situations. The LSAS-SR have shown to have good convergent, discriminant validity, and reliability. The minimum score is 48 and maximum value is 144. A higher score indicate that the patient have greater problems with anxiety, compared to a lower.

Trial Locations

Locations (2)

Psykiatrisk Klinik Maribo; 🇩🇰 Maribo, Sjælland, Denmark

Psykiatrisk Klinik Næstved; 🇩🇰 Næstved, Sjælland, Denmark