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

NCT ID: NCT05018312

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-12-30

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.

Conditions

Psychotherapy; Social Anxiety Disorder; Personality Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified Collaborative Assessment (MCA)

Intervention Type: BEHAVIORAL

The Modified Collaborative Assessment (MCA) will be assessment of the patients that Is more thoroughly-done, and which will be inspired by the school of Therapeutic Assessment and Collaborative Assessment. It will include the EASE, SCID-interview, PSE, ADOS and SCIP-interviews.

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.

Group Type: ACTIVE_COMPARATOR

Assessment as Usual (AAU)

Intervention Type: BEHAVIORAL

Assessment as usual is the standard assessment the patients will receive in the clinic. It includes one or more interviews with a mental health professional in the clinic.

Interventions

Modified Collaborative Assessment (MCA)

The Modified Collaborative Assessment (MCA) will be assessment of the patients that Is more thoroughly-done, and which will be inspired by the school of Therapeutic Assessment and Collaborative Assessment. It will include the EASE, SCID-interview, PSE, ADOS and SCIP-interviews.

Intervention Type: BEHAVIORAL

Assessment as Usual (AAU)

Assessment as usual is the standard assessment the patients will receive in the clinic. It includes one or more interviews with a mental health professional in the clinic.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service

UNKNOWN

Sponsor Role: collaborator

Psychiatric Research Unit, Region Zealand, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Sidse Arnfred

Professor, senior consultant, MD MSc PHD DMSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidse Arnfred, MD PhD DMSc

Role: PRINCIPAL_INVESTIGATOR

Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS

Locations

Psykiatrisk Klinik Maribo

Maribo, Region Sjælland, Denmark

Psykiatrisk Klinik Næstved

Næstved, Region Sjælland, Denmark

Countries

Denmark

References

Hovmand OR, Reinholt N, Dichmann K, Borisov R, Hjorthoj C, Arnfred S. Results of a randomized controlled superiority trial of the effect of modified collaborative assessment vs. standard assessment on patients' readiness for psychotherapy (CO-ASSM-RCT). Trials. 2024 Oct 25;25(1):716. doi: 10.1186/s13063-024-08517-8.

Reference Type: DERIVED

PMID: 39456051 (View on PubMed)

Other Identifiers

2021001

Identifier Type: -

Identifier Source: org_study_id