Condition category
Mental and Behavioural Disorders
Date applied
14/06/2018
Date assigned
20/06/2018
Last edited
20/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People who seek psychiatric assessment expect to receive an explanation for their symptoms. They also want a good interpersonal relationship with their clinician(s), acknowledgment and assurance they are being listened to, and involvement in and information on clinical decisions. Achieving these patient-centred objectives, a case formulation method was implemented based on dialogical sequence analysis (DSA) at a community mental health centre. By identifying the patient’s problematic, recurring psychological action patterns, it helps to improve the psychiatric assessment. This new method may improve the patient-centredness and the validity of the psychiatric assessment for an individual patient. The aim is to achieve better congruence and collaboration between the patient and professionals concerning the tasks and goals of the assessments, and advance the patient’s agency in their treatment. The aim of this study is to compare DSA-based and standard psychiatric assessments.

Who can participate?
Patients aged 18–65 with a referral for a psychiatric assessment

What does the study involve?
Patients are randomly allocated to undergo either the DSA-based assessment or a standard psychiatric assessment. Both groups receive psychiatric treatment in accordance with the usual treatment recommendations. The relationship between the patient and the therapist (therapeutic alliance) is assessed at the treatment planning (i.e. final) visit.

What are the possible benefits and risks of participating?
It is already known that the DSA-based assessment is patient-centred and could complement psychiatric assessment in a collaborative way and result in a better joint understanding regarding the patient’s problems and needs in a shorter time period than the standard assessment. The study does not involve any risks for the patients.

Where is the study run from?
Päijät-Häme Central Hospital (Finland)

When is the study starting and how long is it expected to run for?
February 2014 to March 2017

Funding of the study?
Competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital (Finland)

Who is the main contact?
Dr Enikö Savander

Trial website

Contact information

Type

Public

Primary contact

Dr Enikö Savander

ORCID ID

http://orcid.org/0000-0003-0249-0587

Contact details

Keskussairaalankatu 7
Lahti
FI-15850
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Q275

Study information

Scientific title

Case formulation in psychiatry: do we treat symptoms or do we solve obstacles of individual agency? A single-blind randomised controlled trial

Acronym

Study hypothesis

By implementing dialogical sequence analysis (DSA) based case formulation for the psychiatric assessment, the clinicians can achieve an individual definition of problems and more effective care for the patients.

Ethics approval

Ethics Committee of Tampere University Hospital, 18/09/2014, ref: R 14094

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Psychiatric assessment phase with the patients' diverse symptoms in a community mental health centre

Intervention

The patients were randomised into two groups. The aim was to obtain 40 participants for both study arms. The randomisation was done immediately when the patient’s referral was approved and the assessment phase started. The study protocol was similar in both arms of study. In the first visit, the clinicians informed the patient about the research protocol, provided a written statement, and requested the patient’s consent to participate in the study. Moreover, five randomly selected patients in the AAU group gave their written consent for the assessment process to be audiotaped. In the DSA group, every first visit and some later visits were audiotaped with the patient’s consent.

INTERVENTION: Assessments based on dialogical sequence analysis (DSA group)
In the DSA group, the assessments were carried out by three psychiatrists and three psychologists who participated in a two-year DSA training programme between September 2013 and May 2015. In the DSA group, the patient’s first visit was managed by a psychiatrist-psychologist pair. The visit was divided into two parts. In the first part, the clinicians focused on the patient’s present problem. Here, the clinical interview and the assessment of the patient’s current problem was conducted by the conceptual tools of DSA-based case formulation.
After the initial part of the interview there was a 10–15 minute break, during which the clinicians discussed and shaped a working hypothesis about the patient’s repetitive problematic action patterns that possibly maintained the patient’s distress and symptoms.
In the second part of the first visit the clinicians evaluated the patient’s risk behaviour, possible self-harm, and psychotic symptoms. Similarly, they appraised the patient’s need for other needful clinical interventions, such as medications or laboratory tests and provide statements to allow the patient to receive social security benefits. Finally, the clinicians offered the patient a preliminary formulation of the present problem, which the patient could then reflect on in order to collaborate in advancing the treatment plan. The clinicians and the patient then discussed the content of the subsequent assessment visits and the tentative diagnosis.
Thereafter, the psychologist, the psychiatrist, or both run the following assessment visits depending on the patient’s needs. The purpose was to comprehend in all details the patients’ important life events, problems, symptoms, and relationships with significant others through their narratives. The clinicians observed the patient’s stance on the addressed topic or object by focusing on their gestures, facial expressions, speech prosody, postures, and behaviours.
In the final assessment visit as the treatment-planning session, the clinicians and the patient aimed at clarifying the repetitive external and internal activity patterns that seemed to bring forth and maintain the patient’s present problems. Based on this joint formulation, they shaped the treatment targets and tasks. Moreover, their intent was to identify a diagnosis and determine the immediate and the long-term targets. The clinicians wrote the treatment plan along with case formulation to the patient’s records. After the assessment phase, one of the clinicians continued the treatment according to the treatment plan and schedule.

CONTROL: Assessments as usual (AAU group)
In the AAU group, the assessment team was chosen from a group of seven doctors (psychiatrists and residents), nine psychiatric nurses, and five psychologists who worked and rotated irregularly at the Evaluation Team of the Community Mental Health Care Centre in Lahti. In this group, the patient’s clinical assessment and need for treatment were grounded on the standard symptom-oriented and descriptive diagnostic evaluation guidelines of public mental healthcare. A doctor with a nurse or a psychologist conducted the first visit. During the subsequent assessment visits, one of the clinicians continued the evaluation of the patient’s clinical condition applying the standard symptom-oriented guidelines. In the treatment planning visit, both clinicians presented and shaped the treatment tasks and objectives, and agreed on the subsequent treatment placement with the patient. In that case, if the duration of the treatment was evaluated to last longer than six months, the patient’s treatment was allocated to another Care Team within the same Mental Health Care Centre.

The Working Alliance Inventory (WAI) was used for the self-assessment of the therapeutic alliance in psychotherapy. Both the patient (WAI-P) and therapist (WAI-T) scales consist of 36 items measuring three domains of alliance, namely goals, tasks and bond. In this study, the Finnish version of the Long Form WAI was applied. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) was used as the baseline, which was completed during the first visit. This 34-item self-report instrument was applied to evaluate four domains: subjective well-being (CORE-W), psychic symptoms (CORE-P), life functioning (CORE-F), and risk behaviour (CORE-R). The Finnish version of the CORE-OM was approved by the Core System Trust and validated in Finland. Moreover, the number and durations of visits, the lengths of individual assessment periods and the numbers of clinicians who participated in the various phases of assessment were recorded.
During the first visit, every patient in both study groups was requested to complete the CORE-OM form. Furthermore, in the treatment-planning (i.e. final) visit, patients in both groups were asked to complete a WAI-P scale and to put it in an envelope, making the results of this assessment unknown to the clinicians. The clinicians completed a WAI-T scale together after the patient’s departure. After every visit, the clinicians in both groups completed an evaluation form.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Self-assessment of the therapeutic alliance in psychotherapy using the Working Alliance Inventory (WAI) for the patient (WAI-P) and for the clinicians (WAI-T) at the treatment planning (i.e. final) visit. After the first visit, the number of assessment sessions was not known in advance because of the individual assessment process
2. Employee resources: the lengths of individual assessment sessions and periods, the number of and duration of visits and the number of clinicians who were involved in the various phases of assessment

Secondary outcome measures

The patient-clinician interaction from the patient-centered approach is investigated using qualitative conversation analysis

Overall trial start date

01/02/2014

Overall trial end date

10/03/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with a referral for a psychiatric assessment, sent from primary, occupational, or student healthcare units, or from private practice
2. 18–65 years of age
3. Able to understand the study’s purpose and give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The target number of recruited participants was 40 in both groups/arms

Participant exclusion criteria

1. Subjects whose referral suggested any psychotic or neuropsychiatric disorders, such as attention deficit disorders and autism, or any cognitive disabilities
2. A referral for an emergency or urgent assessment (i.e. within 7 days)
3. The patient’s native language had to be Finnish

Recruitment start date

13/01/2015

Recruitment end date

30/08/2016

Locations

Countries of recruitment

Finland

Trial participating centre

Päijät -Häme Central Hospital
Keskussairaalankatu 7
Lahti
FI-15850
Finland

Sponsor information

Organisation

Päijät-Häme Central Hospital

Sponsor details

Department of Psychiatry
Keskussairaalankatu 7
Lahti
FI-15850
Finland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal during 2018–2022. It is not known whether additional documents will be available.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes