Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001176550
Ethics application status
Approved
Date submitted
18/09/2015
Date registered
2/11/2015
Date last updated
17/04/2019
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
In patients with conversion disorder and healthy volunteers, does a short term stress reduction technique followed by psychotherapy lead to improved processing of stress?
Scientific title
In participants with Conversion disorder and healthy volunteers, does a short term intervention with a breathing stress reduction technique followed by up to 2 years of psychotherapy with the Conversational model lead to improved processing of stress, as evidenced by psychological questionnaires, heart rate variability and attachment status.
Secondary ID [1] 287469 0
Nil Known
Universal Trial Number (UTN)
U1111-1174-3794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conversion Disorder 296201 0
Condition category
Condition code
Mental Health 296478 296478 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Volunteers will participate in Phase 1 Only as described below. including being trained in the breathing stress reduction at baseline and reassessment at 1 month.

Participants with Conversion Disorder will be participate in Phase I and II receiving treatments as specified below.

Phase 1 Both healthy controls and conversion disorder participants complete tasks
a) 1 month of use of a Breathing Stress Reduction Technique for 20 minutes a day.
b) At the end of the session, where their baseline cognitive, emotional and psychological testing is done, they will be trained for one 30 minute one-on-one information session with a psychiatrist to show them the breathing technique. This involves breathing for 10 minutes twice a day at a rate per minute which is optimal for that participant. This optimal breathing rate is found from measuring the participant's heart rate variations as they breath at different rates. The breathing rate which is associated with the smallest stress response, as determined by the magnitude of these heart rate variations, is then chosen as the optimal breathing rate.

During the one-on-one session the participant will be instructed to breath at this optimal rate using a technique that the patient feels comfortable with. These techniques will include using a freely available breathing App for Android or apple mobile phones called MyCalmBeat, which has a picture of two lungs breathing in and out which can be set to breath at the participant's optimal rate for 10 minutes. The participant follows along with the image for 10 minutes. Alternatively, the participant will be trained in how to use a clock or watch with a second timer, by designating how long each breath should take . The chosen method will be practised with the participant in the session until they feel comfortable using the technique alone.
c) Participants will be given a calendar/Study Diary sheet to note down over the following month how often and for how long they do the practise. Notes about the process which the participant feels they need to remember the process can be jotted down on this calendar.

Phase 2 This proceeds directly after Phase 1. and involves Conversion Disorder Participants only
NB. If the time to psychotherapist or neurologist availability is greater than 6 months the participant will repeat initial psychological questionnaires and cognitive testing with WebNeuroTM at the commencement of psychotherapy. They will not repeat the Adult Attachment Interview at this time as this provides stable categories in the absence of psychotherapeutic intervention for at least one to two years, by which time they would have been allocated a therapist.
Treatment with
a) Up to 2 years of Psychotherapy with Conversational Model
i) Conversational Model psychotherapy is a talking therapy which allows the patient to explore their problems for development of a collaborative trusting relationship between therapist and patient. Specific techniques of language usage by the therapist allow the patient to feel more comfortable expressing their emotions and integrating previous life experiences with emotions from present and the past.
ii) Therapy involves meeting for 50 minutes once or twice a week for up to 2 years. This therapy may be either Short Term Intensive Psychotherapy in the Conversational Model or long term psychotherapy in the Conversational Model dependent on assessment.
iii) The sessions are one-on-one face-to-face.
iv) Sessions are run by a therapist training in the Conversational Model at the Westmead Psychotherapy program.. These therapists may be a psychiatrist, nurse, psychologist or social worker or anyone who has been deemed to have met previous training requirements in psychotherapy. The therapist is supervised by a psychotherapist member of the Faculty of Medicine at the University of Sydney.
v) The decision on duration of treatment is made collaboratively with the patient, therapist and Supervisor of the therapy, based on the patient’s clinical symptoms.
vi) Attendance at sessions is monitored by an Occasions of Service attendance register maintained by individual therapist in collaboration with their Supervisor on the basis of audio transcripts of sessions.
b) 1 to 2 years of Neurology Treatment as Usual (including regular Neurology follow-up, assessment and prescription of medication by Psychiatrist and physiotherapy and rehabilitation).
Neurology treatment as usual is tailored to the specific needs of the patient as conversion disorder can manifest in many different types of functional neurological symptoms. This generally includes ongoing evaluation of diagnosis through neurophysiological and pathology tests such as blood tests to monitor for small possibility that the patient has a rare or previously not apparent neurological disorder contributing to their presentation.
Some patients with conversion disorder may agree to referral to psychiatrist for medication and psychological therapy for anxiety and depressive symptoms. Such a decision is made in collaboration with the patient. This psychiatrist involvement may involve monthly or less frequent visits to the psychiatrist for monitoring of ongoing mental states and may be present prior to their being requested to enter the study.
Rehabilitation with physiotherapy +/- Cognitive therapy for goal setting may also be undertaken by the patient as part of the treatment as usual with Neurology.
or
c) combination of a) and b)
or
d) no treatment
Intervention code [1] 292846 0
Behaviour
Intervention code [2] 292847 0
Treatment: Other
Intervention code [3] 292848 0
Rehabilitation
Comparator / control treatment
Phase 1
Controls will also receive the Behaviour treatment with Breathing
Phase 2
Control group does not receive active treatment in Phase 2 d) above
Control group
Active

Outcomes
Primary outcome [1] 296103 0
Mean Heart Rate Variability (HRV) at rest

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability
Timepoint [1] 296103 0
During Baseline testing session after completion of questionnaires
Primary outcome [2] 296105 0
Mean Heart rate variability following a series of cognitive tests as available in WebNeuroTM.

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability

WebNeuro is prorpietary cognitive testing software provided by Brain Resource Company. The tests include: finger tapping speed, reaction time to a picture being shown, how well words or numbers are remembered, working out the emotion in a face in a picture, seeing how well one can focus on something and ignore distractions and finding and remembering a route through a grid of dots from one edge to the other by trial and error.
Timepoint [2] 296105 0
Immediately after measuring the heart rate variability at rest in the same baseline testing session prior to any treatment
Primary outcome [3] 296153 0
Mean Heart Rate Variability following Adult Attachment Interview

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability.
Timepoint [3] 296153 0
This is after a Half to one hour break following WebNeuro testing and then a one to two hour period for Adult Attachment Interview in the same baseline testing session prior to any treatment. The return to rest in HRV is measured for half an hour following completion of the Adult Attachment Interview
Secondary outcome [1] 317517 0
Mean Heart Rate Variability at rest

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability.
Timepoint [1] 317517 0
This is measured one month following the baseline testing session in a second testing session. This baseline testing session, in addition to questionnaires, WebNeuro and Adult Attachment Interview, detailed above, will have a half to one hour training session in breathing stress reduction. The second testing session will have questionnaires and WebNeuro but no Adult attachment Interview or stress reduction training
Secondary outcome [2] 317519 0
Mean Heart rate variability following a series of cognitive tests as available in WebNeuroTM.

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability

WebNeuro is prorpietary cognitive testing software provided by Brain Resource Company. The tests include: finger tapping speed, reaction time to a picture being shown, how well words or numbers are remembered, working out the emotion in a face in a picture, seeing how well one can focus on something and ignore distractions and finding and remembering a route through a grid of dots from one edge to the other by trial and error.
Timepoint [2] 317519 0
This is measured one month following the baseline testing session in a second testing session.
This baseline testing session, in addition to questionnaires, WebNeuro and Adult Attachment Interview, detailed above, will have a half to one hour training session in breathing stress reduction. The second testing session will have questionnaires and WebNeuro but no Adult attachment Interview or stress reduction training.
Secondary outcome [3] 317520 0
Adult Attachment Status as assessed by Adult Attachment Interview
Timepoint [3] 317520 0
At Baseline.
During a one to two hour interview in Baseline testing session ( after completion of questionnaires, and Web Neuro tasks and a half to one hour break.)
Secondary outcome [4] 317521 0
Mean Heart rate variability at rest

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability
Timepoint [4] 317521 0
Following up to 2 years of Neurology Treatment as Usual or Conversational Model Psychotherapy
Secondary outcome [5] 317522 0
Mean Heart rate variability following a series of cognitive tests as available in WebNeuroTM.

HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability

WebNeuro is prorpietary cognitive testing software provided by Brain Resource Company. The tests include: finger tapping speed, reaction time to a picture being shown, how well words or numbers are remembered, working out the emotion in a face in a picture, seeing how well one can focus on something and ignore distractions and finding and remembering a route through a grid of dots from one edge to the other by trial and error. HRV is assessed using a small device which measures blood flow in the body which is attached to the participant by an ear-clip . The heart pulse is such that blood flows in and out of the ear like a wave. The ear-clip device can determines the time points when peaks in this pulse wave occur and a record of the time between peaks can be obtained and fed to a computer. An average of these calculated times between peaks can then be calculated by the computer for a given length of time. The averages obtained summarise the amount of variation between heart beats - the heart rate variability.
Timepoint [5] 317522 0
Immediately following the cognitive test session at end of neurology or psychotherapy treatment
Secondary outcome [6] 317630 0
Adult Attachment Status as assessed by Adult Attachment Interview
Timepoint [6] 317630 0
Following 1-2 years of Neurology Treatment as Usual or Conversational Model Psychotherapy

Eligibility
Key inclusion criteria
General:
English speaking

Group A:
1. A diagnosis of conversion disorder, psychogenic faints or somatization disorder with conversion symptom/s, all with or without somatoform pain. DSM-V criteria will be used for recruitment with all cases co-classified on DSM-IV. This is to facilitate comparison with earlier child study which utilised DSM-IV.
Cases may present with a range of neurological symptoms including motor disturbance/impairment; sensory
impairment, cognitive impairment, psychogenic non-epileptic seizures (PNES) or faints, and with or without somatoform pain.
2. Must have undergone neurology assessment through the Neurology service at Westmead hospital to establish or verify the diagnosis of conversion disorder and to exclude other medical causes for the presenting symptoms/syndromes prior to taking part in the current research.

Group B
Healthy/normative adults.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Exclusion Criteria
1. Insufficiently fluent in English to complete processes of consent and study protocol;
2. Developmental disability;
3. Adults who have a family history of genetic disorders;
4. Chronic medical illness including any impediment to vision, hearing, or hand
movement that prevents completion of the study protocol;
5. Adults with a history of brain injury, or head injury that resulted in unconsciousness within the last 5 years. This is due to the risk of later neurological sequelae such as seizures which may not yet be evident but could impact cognitive and psychological parameters.
6. Adults who, in the opinion of the investigator/s, are unable or unlikely to comprehend or follow the study procedures and instructions due to distress or some other difficulty with language, comprehension or cognition.
7. Adults with co-morbid severe substance use disorder. This is because substances can influence autonomic nervous system reactivity and make it difficult to determine whether a recorded effect is due to the substance use disorder or the conversion disorder.

Group A Specific Exclusion Criteria:

Exclusion criteria include those listed in DSM-V for conversion disorder including another medical explanation for symptoms, such as symptoms limited to fatigue, or a substance use disorder, for reasons described above.
Specifically, patients with other co-morbid psychiatric illnesses are not excluded. This is because patients with conversion disorder have a large array of co-morbid psychiatric diagnoses. Excluding those patients with other psychiatric illnesses would therefore lead to a non-representative sample of typical patients presenting to tertiary assessment centres, making the sample biased.

Group B Specific Exclusion Criteria

Adults with a previous or current Axis-I or Axis II DSM-IV-R diagnosis will be excluded. We understand that this is a stringent requirement where community mental
health diagnoses are not uncommon but, for the clarity of the groups, is necessary.

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)
Allocation is not concealed
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
2 sample t-tests analysis comparing primary outcome measure of mean heart rate variability between the two groups:
Conversion disorder patients versus healthy controls at baseline and following one month of stress reduction training

Secondary outcome measures of change in within-group heart rate variability at baseline and following one month of stress reduction training

Linear mixed effects analysis will be performed on psychological variables in a secondary analysis as obtained from psychological measures, cardiac measures of arousal (heart rate and heart rate variability) and cognitive and emotional processing tasks, with attachment state of mind variables obtained from the Adult Attachment Interview coding identifying sub-groups at baseline.


For adequate power at 80%, and to predict sample size, utilisation is made of the group mean differences in resting cardiac arousal measures from the Child study (Kozlowska, et al 2015). In resting baseline state (2 minutes of eyes open no task) the difference between conversion disorder and control groups in heart rate variability was significant.
For conversion disorder patients (n=57) the measure of heart rate variability was 45.36 and for controls (n=57) was 58.62.This gave a mean difference of -2.55 with t 105=0.012 and a Cohen’s effect size 0.49. There was a range of values of Cohen’s effect size parameters for cardiac arousal levels (heart rate and heart rate variability) ranging from about 0.5 as in the case here in resting state up to about 0.8. The Cohen’s effect size of 0.49 for resting eyes open was therefore chosen as a reasonable lower estimate for the calculation of sample size. To obtain a similar result with 80% power in adults therefore requires control and patient groups numbers each of 65 or more in a two sample T-test design. The initial year of the study aims to recruit around 15 conversion disorder cases and corresponding controls suggesting the study will need to run for about 5 years to collect sufficient data to show an effect on cardiac arousal measures.The child study successfully accrued data over a 5-6 year period.
Kozlowska K Palmer DM Brown KJ mclean L Scher S Gevirtz R Chudleigh C Williams L (2015). Reduction of autonomic regulation in children and adolescents with conversion
disorders. Psychosomatic Medicine 77: 356-370.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2015
Actual
26/11/2015
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4340 0
Westmead Hospital - Westmead
Recruitment hospital [2] 4341 0
Cumberland Hospital - Westmead
Recruitment postcode(s) [1] 10566 0
2151 - North Parramatta
Recruitment postcode(s) [2] 10567 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 292045 0
Other Collaborative groups
Name [1] 292045 0
Royal Australian and New Zealand College of Psychiatry
Country [1] 292045 0
Australia
Funding source category [2] 292046 0
Government body
Name [2] 292046 0
NSW Institute of Psychiatry Research Fellowship [Funding derived from Health Education and Training Institute which began operations on 2 April 2012 as a Statutory Health Corporation following a Ministerial Review of Future Governance for NSW Health]
Country [2] 292046 0
Australia
Funding source category [3] 292047 0
Self funded/Unfunded
Name [3] 292047 0
Assoc Prof Loyola McLean
Country [3] 292047 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital
Institute Rd,
Westmead NSW 2145, NSW, Australia
Country
Australia
Secondary sponsor category [1] 290750 0
Hospital
Name [1] 290750 0
Westmead Hospital
Address [1] 290750 0
Darcy Rd
Westmead NSW 2145
Country [1] 290750 0
Australia
Secondary sponsor category [2] 290751 0
Hospital
Name [2] 290751 0
Cumberland Hospital
Address [2] 290751 0
5 Fleet St
North Parramatta
2151, NSW
Country [2] 290751 0
Australia
Secondary sponsor category [3] 290752 0
Other Collaborative groups
Name [3] 290752 0
Westmead Psychotherapy Program
Address [3] 290752 0
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151 , NSW
Country [3] 290752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293528 0
Western Sydney Local Health District (WSLHD)
Ethics committee address [1] 293528 0
Ethics committee country [1] 293528 0
Australia
Date submitted for ethics approval [1] 293528 0
18/03/2015
Approval date [1] 293528 0
20/08/2015
Ethics approval number [1] 293528 0
(4242) AU RED HREC/15/WMEAD/102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60318 0
A/Prof Loyola McLean
Address 60318 0
Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151, NSW
Country 60318 0
Australia
Phone 60318 0
+61298403335
Fax 60318 0
+61298403572
Email 60318 0
[email protected]
Contact person for public queries
Name 60319 0
Shaun Halovic
Address 60319 0
Project Officer
Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151 , NSW
Country 60319 0
Australia
Phone 60319 0
+61 2 9840 3343
Fax 60319 0
+61298403572
Email 60319 0
[email protected]
Contact person for scientific queries
Name 60320 0
Clare Chapman
Address 60320 0
Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151, NSW
Country 60320 0
Australia
Phone 60320 0
+61 2 9840 3615
Fax 60320 0
+61298403572
Email 60320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics Not updated for data sharing at this point


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.