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

NCT05018312 | Unknown

• 1 other identifier: 2021001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychotherapy; Social Anxiety Disorder; Personality Disorders

Keywords

Therapeutic Assessment; Psychiatry; Person-centered; Mental Health Service; Pre-therapy; Collaborative Assessment

Outcome Measures

Primary Outcomes (1)

• University of Rhode Island Change Assessment Scale (URICA)

  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.

  Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)

Secondary Outcomes (1)

• 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)

Other Outcomes (7)

• Rosenberg Self-Esteem Scale (RSES)

  Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)

• General Self-Efficacy Scale (GSES)

  Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)

• Working Alliance Inventory (WAI)

  T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)

Study Arms (2)

Modified Collaborative Assessment (MCA)

EXPERIMENTAL

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.

Behavioral: Modified Collaborative Assessment (MCA)

Assessment as usual (AAU)

ACTIVE COMPARATOR

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.

Behavioral: Assessment as Usual (AAU)

Interventions

Modified Collaborative Assessment (MCA) 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.

Modified Collaborative Assessment (MCA)

Assessment as Usual (AAU) 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.

Assessment as usual (AAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead
• Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service: collaborator

Study Sites (2)

Psykiatrisk Klinik Maribo

Maribo, Region Sjælland, 4930, Denmark

Location

Psykiatrisk Klinik Næstved

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39456051 DERIVED

MeSH Terms

Conditions

Phobia, Social; Personality Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Sidse Arnfred, MD PhD DMSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will be applied in the data analysis process
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, senior consultant, MD MSc PHD DMSC

Model Details: Naturalistic, superiority trial

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 24, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: December 30, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)