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Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety (CO-ASSM-RCT)

Primary Purpose

Psychotherapy, Social Anxiety Disorder, Personality Disorders

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Modified Collaborative Assessment (MCA)
Assessment as Usual (AAU)
Sponsored by
Psychiatric Research Unit, Region Zealand, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotherapy focused on measuring Therapeutic Assessment, Psychiatry, Person-centered, Mental Health Service, Pre-therapy, Collaborative Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psykiatrisk Klinik Maribo
  • Psykiatrisk Klinik Næstved

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Collaborative Assessment (MCA)

Assessment as usual (AAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Liebowitz Social Anxiety Scale-Self- Report (LSAS)
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.

Full Information

First Posted
July 29, 2021
Last Updated
March 27, 2023
Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
Collaborators
Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT05018312
Brief Title
Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety
Acronym
CO-ASSM-RCT
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
Collaborators
Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy, Social Anxiety Disorder, Personality Disorders
Keywords
Therapeutic Assessment, Psychiatry, Person-centered, Mental Health Service, Pre-therapy, Collaborative Assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Naturalistic, superiority trial
Masking
None (Open Label)
Masking Description
Masking will be applied in the data analysis process
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Collaborative Assessment (MCA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment as usual (AAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modified Collaborative Assessment (MCA)
Intervention Description
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
Intervention Name(s)
Assessment as Usual (AAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
University of Rhode Island Change Assessment Scale (URICA)
Description
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.
Time Frame
Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)
Secondary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale-Self- Report (LSAS)
Description
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.
Time Frame
Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Other Pre-specified Outcome Measures:
Title
Rosenberg Self-Esteem Scale (RSES)
Description
The RSES is a 10-item measure of self-esteem that includes five positive items and five negative items which are reversed scored (Rosenberg, 1965). In general, the RSES has demonstrated good convergent validity and good test-retest reliability and in similar populations of adults with social phobia, the RSES has demonstrated high internal consistency. The minimum score is 10 and maximum value is 40. A higher score indicate that the patient has a better self-esteem, compared to a lower.
Time Frame
Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Title
General Self-Efficacy Scale (GSES)
Description
The GSE is a 10-item psychometric scale that is designed to a ssess optimistic self-beliefs to cope with a variety of difficult demands in life. In contrast to other scales that were designed to assess optimism, this one explicitly refers to personal agency, i.e., the belief that one's actions are responsible for successful outcomes. The minimum score is 10 and maximum value is 40. A higher score indicate that the patient feels better suited to handle difficult situations, compared to a lower.
Time Frame
Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Title
Working Alliance Inventory (WAI)
Description
The WAI is a 12-item psychometric questionnaire that is designed to assess the therapeutic alliance between a patient and a therapist. The questionaire isn't scored.
Time Frame
T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
The CSQ-8 is a self-report questionnaires constructed to measure satisfaction with services received by individuals and families. The minimum score is 8 and maximum value is 32. A higher score indicate that the patient is more satisfied with the treatment, compared to a lower.
Time Frame
T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Title
National Patient Reported Outcome Measures (PROM)- Psychiatry
Description
The Danish National PROM is a 19-item, self-report measure covering patients own view on their mental and physical health, and level of general well-being. The minimum score is 19 and maximum value is 114. A higher score indicate that the patient is less burdened by his/her symptoms, compared to a lower.
Time Frame
Baseline T0 (end of intervention, an average of four weeks after allocation); T1 (end of intervention) and T2 (after one month psychotherapy)
Title
Purpose-made questionary on specific feasibility-outcomes
Description
We intend to - for the purpose of this trial - construct questionnaires evaluating the patients' and clinicians´ evaluation of the intervention.
Time Frame
T1 (end of intervention, an average of four weeks after allocation)
Title
Readiness for Psychotherapy Index
Description
The RPI is a 20-item self-report measure that uses a 5-point Likert scale to assess 7 dimensions of readiness for psychotherapy: level of distress, desire for change, willingness to work in therapy, recognition of problems as psychological, willingness to discuss personal matters, willingness to endure discomfort in therapy, and responsibility for change. The questionnaire will be translated and validated for use in a Danish mental health service population. The minimum score is 20 and maximum value is 100. A higher score indicate that the patient is less ready to participate in psychotherapy, compared to a lower.
Time Frame
Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidse Arnfred, MD PhD DMSc
Organizational Affiliation
Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psykiatrisk Klinik Maribo
City
Maribo
State/Province
Sjælland
ZIP/Postal Code
4930
Country
Denmark
Facility Name
Psykiatrisk Klinik Næstved
City
Næstved
State/Province
Sjælland
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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