Condition category
Not Applicable
Date applied
03/05/2019
Date assigned
30/07/2019
Last edited
16/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Expectations of help from psychiatric care can be mixed. Poor mental health can also be felt and expressed in many ways. Prior to any psychiatric treatment, an assessment is made of the patient's mental health and, if relevant, a diagnosis is set.
In order to understand the individual patient's experience and understanding of his or her problems, a new interview has been included in DSM-5, a manual for psychiatric diagnosis. This interview is intended for use in psychiatric diagnostics and is called the Cultural Formulation Interview. During the interview patients are asked how they view, and can explain, their problems They are also asked about their expectations of help. The interview also includes questions regarding the significance of the patient's social and cultural environment.
The aim of this study is to assess whether the new Cultural Formulation Interview, as described in DSM-5, can improve the understanding, assessment and treatment of a patient's mental health problems.

Who can participate?
Patients who came into contact with Järvapsykiatrin during the period August 2015 to May 2017, were invited to participate in the study.

What does the study involve?
All those participating in the study were given the standard form of psychiatric assessment and a treatment plan, at the clinic and on the ward. As well as this, half of the participants were questioned using the new Cultural Formulation Interview. Those questioned using this new interview were selected by lottery. The interview took approximately 20 minutes and was carried out during an ordinary appointment at the outpatient clinic.
The study compared the details of psychiatric assessment relating to the group where the new Cultural Formulation Interview was used with the details relating to the group where it was not. The comparisons were made anonymously. Treatment was given according to the usual procedures of the outpatient clinic.

What are the possible benefits and risk of participating?
One advantage of participating in the study was that the questions asked in the new Cultural Formulation Interview may have given the caseworker a better understanding of the patient's problems, needs and wishes. There may have been a risk that the questions asked in the new interview were perceived as difficult to understand or made the interviewee feel uncomfortable. If this was the case, the interview was terminated immediately, and an opportunity given to address this with the staff in charge of treatment.

Where is the study run from?
The principal body for the research was Stockholm County Council, Box 22550, 104 22 Stockholm. The study was conducted in collaboration between Transcultural Centre, Stockholm County Council and Järvapsykiatrin, Praktikertjänst AB.

When is the study starting and how long is it expected to run for?
Data collection was between 1/8/2015 and 31/5/2017

Who is funding the study?
The study was funded by Stockholm County Council with the research grant, PPG PPG-fund, Dnr LS1311-1462

Who is the main contact?
The personal data officer in charge of the details relating to the researchers and participants is Sofie Bäärnhielm, Transcultural Centre, Solnavägen 4, 113 65 Stockholm phone +46 8 123 486 79, mobile +46 70 484 61 62, email sofie.baarnhielm@sll.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sofie Baarnhielm

ORCID ID

http://orcid.org/0000-0002-5303-9166

Contact details

Transcultural Center
Solnavägen 4
Stockholm
113 65
Sweden
+46 8 123 486 79
sofie.baarnhielm@sll.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Dnr LS 1311-1462

Study information

Scientific title

Evaluating the Cultural Formulation Interview in DSM-5. A randomized controlled trial.

Acronym

Study hypothesis

1. More patients in the Cultural Formulation Interview (CFI) group than in the usual routine group will get a depression diagnosis after the initial diagnostic procedure
2. More patients in the CFI group than in the usual routine group will get an anxiety diagnosis after the initial diagnostic procedure

Ethics approval

Approved 11/03/2015, The Regional Ethical Review Board in Stockholm (Etikprövingsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; + 46 10-475 08 00; registrator@etikprovning.se), ref: 2015/243-31/2.

Study design

Single centre individually randomized controlled parallel trial unblinded

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Psychiatric diagnostic evaluation

Intervention

The intervention group is interviewed with core Cultural Formulation Interview (CFI) in DSM-5 in addition to the standard psychiatric diagnostic procedure, which besides the CFI is the same for both the intervention and control groups.

The assessment for referral inclusion and exclusion criteria is made by a team at the clinic in charge of examining new referrals. The same team perform the individual randomization, to intervention or control arm done by lottery.

The standard psychiatric diagnostic procedure for psychiatric care in Stockholm County was used in both study arms. This includes social and clinical anamneses; the assessment tool MINI (The Mini International Neuropsychiatric Interview); CGI (Clinical Global Impression); and three web-based self-report screening tools, AUDIT-C (Alcohol Use Disorder Identification Scale), PHQ-9 (Patient Health Questionnaire) and ASRS (Adult ADHD Self-Report Scale). The CFI was also used as a part of the diagnostic evaluation in the intervention arm.

The standard psychiatric diagnostic procedure used in psychiatric care in Stockholm County usually takes between one to four, 45-minute clinical appointments.

The CFI used in the intervention arm takes between 20-40 minutes.

Individual randomisation, to intervention or control arm, was carried out by lottery.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The diagnostic advantage measured using the difference or ratio in the prevalence of the diagnoses of depression (F32.0-F39.0) and anxiety (F41.0-F41.9) after the completion of the diagnostic procedure

Secondary outcome measures

1. The prevalence of depression diagnoses (F32.0-F39.0) and anxiety diagnoses (F41.0-F41.9) after the end of the diagnostic procedure in patients with “Swedish as mother tongue” and those with a “non-Swedish mother tongue”

Overall trial start date

01/01/2014

Overall trial end date

31/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. New patients who have not been in contact with psychiatric care at Järva Psychiatric clinic for the preceding two years.
2. Aged 18-64.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 in each arm.

Participant exclusion criteria

1. Suicidal risk.
2. Inability to take a conscious decision (e.g. impaired cognition or psychosis).
3. Need for acute treatment.

Recruitment start date

01/08/2015

Recruitment end date

31/05/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Transcultural Center.
Solnavagen 4
Stockholm
113 65
Sweden

Trial participating centre

Praktikertjanst, Psykiatri
Salagatan 2
Spanga
163 53
Sweden

Sponsor information

Organisation

Karolinska University Hospital

Sponsor details

FoU
Karolinska University Hospital
Eugeniavägen
Solna
Stockholm
171 76
Sweden
+46 8 517 700 00
registrator.karolinska@sll.se

Sponsor type

Hospital/treatment centre

Website

www.karolinska.se

Funders

Funder type

Government

Funder name

Mission Mental Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

PPG Industries

Alternative name(s)

PPG Industries, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

The results of the trial are planned to be published in autumn 2020.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality

Intention to publish date

12/10/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/08/2019: The participant information sheet was uploaded. 29/07/2019: Trial’s existence confirmed by Regional Ethical Review Board Stockholm