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Trial registered on ANZCTR


Registration number
ACTRN12618000181202
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
5/02/2018
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brief Psychodynamic Therapy for Functional Neurological Symptoms
Scientific title
Impact of Brief Outpatient Psychodynamic Therapy on Mental and Physical Wellbeing for Functional Neurological Symptoms in Adults: A Pilot Study
Secondary ID [1] 292957 0
None
Universal Trial Number (UTN)
U1111-1202-5895
Trial acronym
FNS Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
conversion disorder 304854 0
functional neurological symptom disorder 304855 0
psychogenic non epileptic seizures 304856 0
Condition category
Condition code
Mental Health 304159 304159 0 0
Other mental health disorders
Neurological 304160 304160 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients diagnosed by a Neurologist with Functional Neurological Symptom Disorder with residual symptoms despite diagnosis and treatment as usual will have four sessions of psychodynamic therapy incorporating individualised formulation and management advice based on assessment of history and mental state examination.

All participants will be directed to the www.neurosymptoms.org website, and an individualised farewell letter will be provided to all participants at the final session. No other materials will be provided. The procedure will be face to face psychotherapy administered by talking and listening with attention to both spoken and unspoken communication. This will be administered by a single clinician, Dr Myles Gutkin and will occur four times with one month between each session. Each session will last two hours, but if considered necessary and appropriate by the clinician, the first session may last as long as three hours and subsequent sessions may be as short as one hour. All interventions will occur in the Academic and Liaison Psychiatry Department at Royal North Shore Hospital. Voice recordings of sessions will be used to assess adherence to the protocol by A/Prof. Loyola McLean at fortnightly supervision sessions when directions will be given to ensure adherence to protocol as necessary.

All participants will complete a questionnaire before each interview and again several months after the last contact during a follow up phone call. A clinician administered measure of dissociation will be completed in the first appointment and again during the follow up phone call. A modified adult attachment interview (AAI) will be incorporated into the first session for subsequent analysis. The voice recordings will be transcribed externally for thematic analysis and production of a case series.
Intervention code [1] 299194 0
Behaviour
Intervention code [2] 299978 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303469 0
Physical and mental wellbeing as assessed by the Sf-12v2 questionaire completed in person (or by telephone 3 months after last appointment).
Timepoint [1] 303469 0
Before each of four appointments at month 1, 2, 3, 4 and then 3 months after last appointment (primary endpoint).
Primary outcome [2] 304372 0
Self-reported number of medical presentations the one week prior recorded by questionnaire completed in person (or by telephone 3 months after last appointment). This question is part of a questionnaire created by the investigator specifically for this study.
Timepoint [2] 304372 0
Before each of four appointments at month 1, 2, 3, 4 and then 3 months after last appointment (primary endpoint).
Primary outcome [3] 304373 0
Self-reported agreement with and understanding of diagnosis measured on a 5 point scale recorded by questionnaire completed in person (or by telephone 3 months after last appointment). This question is part of a questionnaire created by the investigator specifically for this study.
Timepoint [3] 304373 0
Before each of four appointments at month 1, 2, 3, 4 and then 3 months after last appointment (primary endpoint).
Secondary outcome [1] 339013 0
Investigator reported HoNOS measure of participant documented on a paper HoNOS form immediately after each patient contact.
Timepoint [1] 339013 0
After each of four appointments at month 1, 2, 3, 4 and then 3 months after last appointment.
Secondary outcome [2] 339014 0
Modified Adult Attachment Interview coded by A/Prof. Loyola McLean from transcribed first sessions.
Timepoint [2] 339014 0
Following the first appointment at month 1.
Secondary outcome [3] 341758 0
Number of paroxysmal events (if relevant) [Primary outcome] recorded by questionnaire completed in person (or by telephone 3 months after last appointment). This question is part of a questionnaire created by the investigator specifically for this study.
Timepoint [3] 341758 0
Before each of four appointments at month 1, 2, 3, 4 and then 3 months after last appointment.

Eligibility
Key inclusion criteria
Patients diagnosed by a Neurologist with Functional Neurological Symptom Disorder with residual symptoms despite a clear diagnosis and treatment as usual. Over 16 years old and able to consent. Able to speak and understand English or a language for which translation services are readily available.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 or unable to consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Statistical analysis of quantitative data will proceed via repeated measures analysis using paired t-tests, comparing measures from entry and exit and then exit with follow-up data to check benefits have not decayed.

The nature of the therapeutic interactions and patient narratives of the story of symptom formation will be explored through thematic and discourse analysis.

Rates and nature of comorbid psychiatric diagnoses in this population will be described.

Modified Adult Attachment Interviews and Shutdown Dissociation interviews will be scored to indicate rates of each attachment style and rates of dissociation.

Collaborative formulations which are agreed upon with the participants will be used to inform case reports.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9091 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17585 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297581 0
Government body
Name [1] 297581 0
Health Education Training Institute Higher Education
Address [1] 297581 0
101/5 Fleet St, North Parramatta NSW 2151
Country [1] 297581 0
Australia
Funding source category [2] 297583 0
Other Collaborative groups
Name [2] 297583 0
Royal Australian New Zealand College of Psychiatrists
Address [2] 297583 0
309 La Trobe Street, Melbourne VIC 3000
Country [2] 297583 0
Australia
Primary sponsor type
Government body
Name
Health Education Training Institute Higher Education
Address
101/5 Fleet St, North Parramatta NSW 2151
Country
Australia
Secondary sponsor category [1] 296594 0
Other Collaborative groups
Name [1] 296594 0
Royal Australian New Zealand College of Psychiatrists
Address [1] 296594 0
309 La Trobe Street, Melbourne VIC 3000
Country [1] 296594 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298674 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298674 0
NSLHD Research Office, Level 13, Kolling Building, Royal North Shore Hospital, St Leonards NSW 2065.
Ethics committee country [1] 298674 0
Australia
Date submitted for ethics approval [1] 298674 0
08/05/2017
Approval date [1] 298674 0
09/06/2017
Ethics approval number [1] 298674 0
HREC/17/HAWKE/141

Summary
Brief summary
Adults diagnosed by a Neurologist with Functional Neurological Symptom Disorder with residual symptoms despite diagnosis and treatment as usual will be seen for four two hour sessions of psychodynamic therapy with a Psychiatrist incorporating a comprehensive psychiatric history and formulation followed by management recommendations. Family and carers will be invited to join the planning component of sessions. At the final session a personalised "farewell" letter will be given to participants and a medical letter will be sent to referring and other treating doctors incorporating managment recommendations.

All participants will complete a questionnaire in person before each interview and again three months after the last session by phone. A clinician administered measure of dissociation will be completed in the first appointment and again at the final session and during the follow up phone call. A modified adult attachment interview (AAI) will be incorporated into the first session for subsequent analysis. The assessments will be voice recorded for later assessment of interaction and adjherence to protocol by a supervisor and will be transcribed externally for thematic analysis and production of a case series. The clinician will also complete a HoNOS measure about the patient after each session and after the follow up phone call three months after the last session..

Statistical analysis will compare measures from before the first and last sessions as well as the measures at follow-up. The therapeutic interactions and patient narratives will be explored for themes. Rates and nature of additional psychiatric diagnoses in this population will be described. Modified Adult Attachment Interviews and Shutdown Dissociation interviews will be scored to indicate rates of each attachment style and rates of dissociation. Collaborative formulations which are agreed upon with the participants will be used to produce a case series.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77850 0
Dr Myles Gutkin
Address 77850 0
Department of Academic and Liaison Psychiatry, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 77850 0
Australia
Phone 77850 0
+61 2 94631507
Fax 77850 0
Email 77850 0
myles.gutkin@unimelb.edu.au
Contact person for public queries
Name 77851 0
Dr Myles Gutkin
Address 77851 0
Department of Academic and Liaison Psychiatry, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 77851 0
Australia
Phone 77851 0
+61 2 94631507
Fax 77851 0
Email 77851 0
myles.gutkin@unimelb.edu.au
Contact person for scientific queries
Name 77852 0
Dr Myles Gutkin
Address 77852 0
Department of Academic and Liaison Psychiatry, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards NSW 2065
Country 77852 0
Australia
Phone 77852 0
+61 2 94631507
Fax 77852 0
Email 77852 0
myles.gutkin@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results