Can incorporating person-centered cultural assessments into psychiatric diagnostic evaluation affect the prevalence of anxiety and depression diagnoses?
| ISRCTN | ISRCTN51527289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51527289 |
| Secondary identifying numbers | Dnr LS 1311-1462 |
- Submission date
- 03/05/2019
- Registration date
- 30/07/2019
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Transcultural Center, Solnavägen 4
Stockholm
113 65
Sweden
 ORCID ID |
0000-0002-5303-9166 |
|---|---|
| Phone | +46 8 123 486 79 |
| sofie.baarnhielm@sll.se |
Study information
| Study design | Single centre individually randomized controlled parallel trial unblinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN51527289_PIS_29Jul2019.pdf |
| Scientific title | Evaluating the Cultural Formulation Interview in DSM-5. A randomized controlled trial. |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2014 |
| Completion date | 31/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 150 in each arm. |
| Total final enrolment | 114 |
| Key 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. |
| Key exclusion criteria | 1. Suicidal risk. 2. Inability to take a conscious decision (e.g. impaired cognition or psychosis). 3. Need for acute treatment. |
| Date of first enrolment | 01/08/2015 |
| Date of final enrolment | 31/05/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
113 65
Sweden
Spanga
163 53
Sweden
Sponsor information
Hospital/treatment centre
FoU
Karolinska University Hospital
Eugeniavägen
Solna
Stockholm
171 76
Sweden
| Phone | +46 8 517 700 00 |
|---|---|
| registrator.karolinska@sll.se | |
| Website | www.karolinska.se |
"ROR" |
https://ror.org/00m8d6786 |
Funders
Funder type
Government
No information available
Government organisation / For-profit companies (industry)
- Alternative name(s)
- PPG Industries, Inc., Pittsburgh Plate Glass Company, Pittsburgh Plate Glass, PPG
- Location
- United States of America
Results and Publications
| Intention to publish date | 12/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of the trial are planned to be published in autumn 2020. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/07/2019 | 16/08/2019 | No | Yes | |
| Results article | 01/08/2020 | 07/09/2021 | Yes | No | |
| Results article | 25/02/2022 | 18/08/2023 | Yes | No |
Additional files
- ISRCTN51527289_PIS_29Jul2019.pdf
- Uploaded 16/08/2019
Editorial Notes
18/08/2023: Publication reference added.
07/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/08/2019: The participant information sheet was uploaded.
29/07/2019: Trial’s existence confirmed by Regional Ethical Review Board Stockholm.
