ANZCTR - Registration

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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

During Baseline testing session after completion of questionnaires

Primary outcome [2]

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]

Immediately after measuring the heart rate variability at rest in the same baseline testing session prior to any treatment

Primary outcome [3]

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]

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]

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]

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]

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]

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]

Adult Attachment Status as assessed by Adult Attachment Interview

Timepoint [3]

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]

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]

Following up to 2 years of Neurology Treatment as Usual or Conversational Model Psychotherapy

Secondary outcome [5]

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]

Immediately following the cognitive test session at end of neurology or psychotherapy treatment

Secondary outcome [6]

Adult Attachment Status as assessed by Adult Attachment Interview

Timepoint [6]

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

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]

Westmead Hospital - Westmead

Recruitment hospital [2]

Cumberland Hospital - Westmead

Recruitment postcode(s) [1]

2151 - North Parramatta

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Royal Australian and New Zealand College of Psychiatry

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

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]

Australia

Funding source category [3]

Self funded/Unfunded

Name [3]

Assoc Prof Loyola McLean

Country [3]

Australia

Primary sponsor type

Government body

Name

Western Sydney Local Health District

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Westmead Hospital

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Cumberland Hospital

Country [2]

Australia

Secondary sponsor category [3]

Other Collaborative groups

Name [3]

Westmead Psychotherapy Program

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District (WSLHD)

Ethics committee address [1]

Westmead Research Office
Research & Education Network building (old WMI bldg)
Westmead Hospital
Darcy Road
Westmead 2145

WSLHD Research Office
Research & Education Network
PO Box 533
Wentworthville NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/03/2015

Approval date [1]

20/08/2015

Ethics approval number [1]

(4242) AU RED HREC/15/WMEAD/102

Summary

Brief summary

Conversion disorder is a health condition in which a person experiences problems with moving parts of their body or other nervous system symptoms that can’t be explained by a medical assessment. These symptoms are thought to be due to stress. This project wants to determine if different conversion disorder symptoms are associated with particular patterns of feeling and thinking, and managing stress and relationships. We also want to test whether a breathing technique aimed at reducing stress when practiced for 20 minutes a day for a month leads to greater calmness and a reduction in conversion disorder symptoms 

A useful treatment for those with Conversion Disorder is regular weekly Psychotherapy for the purpose of understanding a patient’s problems. It does not normally, however, involve specific breathing techniques. This study wants to find out if using the breathing techniques before and potentially during up to 2 years of “talking” psychotherapy makes the psychotherapy more effective in reducing conversion disorder symptoms. We also want to compare the way symptoms and stress change with standard Neurology treatment versus psychotherapy alone or with combined Neurology and psychotherapy treatments.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Loyola McLean

Address

Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151, NSW

Country

Australia

Phone

+61298403335

Email

loyola.mclean@sydney.edu.au

Contact person for public queries

Name

Shaun Halovic

Address

Project Officer
Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151 , NSW

Country

Australia

Phone

+61 2 9840 3343

Email

shaun.halovic@health.nsw.gov.au

Contact person for scientific queries

Name

Clare Chapman

Address

Westmead Psychotherapy Program
Mental Health Sciences Building 112
Cumberland Hospital
5 Fleet St
North Parramatta 2151, NSW

Country

Australia

Phone

+61 2 9840 3615

Email

clare.chapman@health.nsw.gov.au

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