PsychotherapyCO-ASSM-RCTNCT05018312
Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety
A study testing Modified Collaborative Assessment (MCA) and Assessment as Usual (AAU) in people with Psychotherapy and Social Anxiety Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotherapy, Social Anxiety Disorder, Personality Disorders
- What is being tested?
- Modified Collaborative Assessment (MCA) and Assessment as Usual (AAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Psykiatrisk Klinik Maribo
Maribo, Region Sjælland, 4930
Psykiatrisk Klinik Næstved
Næstved, Region Sjælland, 4700
About this study
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)
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.
Read the 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.
- Being tested
- Modified Collaborative Assessment (MCA), Assessment as Usual (AAU)
- Keywords
- Therapeutic Assessment, Psychiatry, Person-centered, Mental Health Service, Pre-therapy, Collaborative Assessment
- Medical subject headings
- Phobia, Social, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Collaborative Assessment (MCA)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Assessment as Usual (AAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Naturalistic, superiority trial
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidse Arnfred, Psychiatric Research Unit, Region Zealand, Denmark
- Investigators
- Sidse Arnfred, MD PhD DMSc, Principal investigator, Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018312
- Sponsor's protocol ID
- 2021001
- Acronym
- CO-ASSM-RCT
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39456051
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05018312
- Acronym / sponsor ID
- CO-ASSM-RCT / 2021001
- Keywords
- Therapeutic Assessment, Psychiatry, Person-centered, Mental Health Service, Pre-therapy, Collaborative Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Naturalistic, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Modified Collaborative Assessment (MCA) | Experimental | Behavioral: 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) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Modified Collaborative Assessment (MCA) |
| 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. | Behavioural | Assessment as usual (AAU) |
Primary outcome
University of Rhode Island Change Assessment Scale (URICA)
Time frame: 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.
1 secondary outcome
Liebowitz Social Anxiety Scale-Self- Report (LSAS)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 39456051Hovmand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidse Arnfred, MD PhD DMSc principal investigator
Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Collaborative Assessment (MCA) and Assessment as Usual (AAU) in people with Psychotherapy and Social Anxiety Disorder, run by Psychiatric Research Unit, Region Zealand, Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Rhode Island Change Assessment Scale (URICA) (time frame: Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.