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Trial registered on ANZCTR


Registration number
ACTRN12618002024224
Ethics application status
Approved
Date submitted
29/01/2018
Date registered
18/12/2018
Date last updated
8/06/2021
Date data sharing statement initially provided
18/12/2018
Date results provided
8/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mind-body interventions in patients with multiple sclerosis
Scientific title
Efficacy of mind-body interventions in patients with multiple sclerosis and walking limitation
Secondary ID [1] 293900 0
Nil Known
Universal Trial Number (UTN)
U1111-1208-4466
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 306376 0
Condition category
Condition code
Neurological 305459 305459 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients included in the hypnoanalysis group should assist to 11 sessions which consisted in 1 interview and 10 hypnotic sessions that lasted around 1 hour (1 weekly) performed as follow: 1) the first day consisted in a semi-structured interview of questions related with their life, before, during and after the diagnosis, a possible emotional cause of the disease and impressive events before the disease; 2) the second session was performed in hypnosis and consisted in the search in the “book of their life” of at least for 5 events related with the cause of the disease and in the restructuring of at least one of the events that apparently still affected the patient, these restructuring was based in the reimprinting technique described by Dilts et al.(this technique consisted in modify the traumatic scene by identifying the resources that the patients and the others involved ones needed, and changing the possible beliefs created in the event); 3) the third session consisted in calling the responsible part of the disease and asking it for the cause(s) of the disease and possible solutions of it and repeat each possible solution 100 times in their mind and if they agreed they made a commitment with that part to change in that aspects; 4) the fourth day consisted in talking with the inner child and with their perfect or ideal version and asking them what they needed to be happy (in the case of the child) and to be like them (in the case of their perfect version) and they made a commitment with both parties to change what they ask for, finally they performed a final fusion among them and the child and the perfect version; 5) the fifth session consisted in searching in the book of healing for all possible actions that will lead to the physical improvement of disease and repeat them 100 times; 6) the sixth session consisted in a script related to mind-body interconnection based in a script of Satir ; 7) the seventh session consisted in a script that gave them to a motivating future, based in a script of Virginia Satir; 8) the eight session consisted in visualizing the brain and the immunology system before the disease and now, looking for differences and asking them what they should do to be like before the disease and make a commitment with that cells in doing what they ask them; 9) the ninth session consisted in repeating the script related to mind-body interconnection ; 10) the tenth session consisted in comparing 3 events that had predisposed to the disease with events that had predisposed to healing in their life and identify the abilities that will help them to perform the second ones and repeat that abilities 100 times in their mind (Supplementary file 3); 11) the eleventh session consisted in repeating the script of a motivating future. In addition 15 minutes of healing imagery were also included in at least in 5 sessions. The same person, performed all sessions and after the post-intervention measurement, the patients were given the transcripts of their hypnotic trances. It is important to mention that all answers were specified with more questions until a clear answer was provided (i.e.: if the answer was “because I was afraid” the next question was “What were you afraid of?”).
Intervention code [1] 300168 0
Treatment: Other
Comparator / control treatment
The number of patients in the imagery group were 8 and in the hypnoanalysis group 7.
The patients that were included to the imagery group assisted weekly to 10 group sessions of body relaxation and healing imagery using light water and air, named “meditation”, which lasted from 30-40 minutes; additionally they were given a recording with the meditation which was send to them by watts up and they were asked to listen and exercise it daily reporting the days which they had listened at it in the next group session. Each group session consisted in 2 hours in which the experience with the meditation of the past week was commented in the first hour and the second one was employed in the healing meditation, at least 4 group sessions were also audio recorded and send to them to use them alternatively to the first recording. An experimented psychologist performed all group sessions and the recordings.
Control group
Active

Outcomes
Primary outcome [1] 304598 0
Patient functionality measured by the expanded disability status scale.
Timepoint [1] 304598 0
this variable was measured 1 week before the first intervention and 1-2 weeks after the last intervention and in a follow up 3 months later.
Primary outcome [2] 308449 0
the primary caregivers were measured for anxiety state and trait with the State-Trait Anxiety Inventory (STAI)
Timepoint [2] 308449 0
this variable was measured 1 week before the first intervention and 1-2 weeks after the last intervention and 3 months later.
Primary outcome [3] 308451 0
For primary caregivers: The Zarit burden inventory
Timepoint [3] 308451 0
This variable was measured 1 week before the first intervention and 1-2 weeks after the last intervention and 3 months later
Secondary outcome [1] 342502 0
The quality of life measured with the short form 36 health questionnaire, SF-36
Timepoint [1] 342502 0
this variable was measured 1 week before the first intervention and 1-2 weeks after the last intervention and in a follow up 3 months later.

Eligibility
Key inclusion criteria
Patients older than 18 years
Patients with multiple sclerosis diagnosed with the McDonald criteria
Patients with walking limitation, with at least 6 points in the Expanded disability status scale (EDSS score equal or more than 6)
Patients that want voluntarily participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cognitive impairment that prevent to perform the interventions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, the allocation was concealed and performed with numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation was stratified by the functionality score, measured with the EDSS, randomization was performed using procedures like coin-tossing and dice-rolling
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample calculation was performed with the the formula to compare to means, calculating the minimum of patients to discriminate a the difference of 1 point in the EDSS between groups.
The differences in functionality, measured with the EDSS and in the quality of life, measured by the SF-36, will be compared with the Student T test for independent samples if the distribution of the variables is parametric or with the Mann-whitney U test if it is non-parametric.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/10/2017
Date of last participant enrolment
Anticipated
Actual
9/11/2017
Date of last data collection
Anticipated
Actual
24/08/2018
Sample size
Target
7
Accrual to date
Final
7
Recruitment outside Australia
Country [1] 9532 0
Mexico
State/province [1] 9532 0
Jalisco

Funding & Sponsors
Funding source category [1] 298522 0
Self funded/Unfunded
Name [1] 298522 0
Aniel Jessica leticia Brambila Tapia
Country [1] 298522 0
Mexico
Primary sponsor type
Individual
Name
Aniel Jessica Leticia Brambila Tapia
Address
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud, Departamento de Psicología Básica, Sierra Mojada #950, Colonia Independencia, Guadalajara, Jalisco, México
Country
Mexico
Secondary sponsor category [1] 297670 0
None
Name [1] 297670 0
Address [1] 297670 0
Country [1] 297670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299500 0
"Comité de Ética, investigación y Bioseguridad" de la Universidad de Guadalajara
Ethics committee address [1] 299500 0
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud (CUCS), Sierra Mojada # 950, Guadalajara, Jalisco, México.
Ethics committee country [1] 299500 0
Mexico
Date submitted for ethics approval [1] 299500 0
05/08/2016
Approval date [1] 299500 0
01/08/2017
Ethics approval number [1] 299500 0
CI-:01717

Summary
Brief summary
In this study we intend to prove if the search and modify (or restructuring) of a possible "emotional cause" of the disease during an hypnotic trance as well as to know the possible causes and solutions of the disease according to the patients´ unconscious, improves the disability (measured with the expanded disability status scale, EDSS) of patients with multiple sclerosis and walking limitation (with the need from a walking stick to a wheelchair to move), as well as the quality of life.
In this study the patients have been followed for a period of 10 weeks before the randomization in 2 intervention groups, the randomization was performed according to the disability (measured by the EDSS), during these 10 weeks the endpoint variables (the EDSS and the quality of life measured by the SF-36 health survey questionnaire) have been measured in order to know the evolution of each patient without any mind-body intervention.
The experimental group is the hypnosis group and the active control group is the healing imagery group, in the experimental group the patients will receive an individualized hypnotic therapy with an experimented professional that will search a possible emotional cause of the disease in the half of the sessions (5 sessions) and in the other half of the sessions will do healing imagery technique during the trance, each session will be performed once a week.
In the active control group, the 10 group weekly sessions will be only directed to healing imagery. The endpoint variables will be measured at the end of the 10 week intervention and a comparison of the differences in these variables between groups will be performed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80630 0
Prof Aniel Jessica Leticia Brambila Tapia
Address 80630 0
Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud, Sierra Mojada #950 Colonia Independencia, Guadalajara, Jalisco México
Country 80630 0
Mexico
Phone 80630 0
+52 3310941782
Fax 80630 0
Email 80630 0
anieljessica@hotmail.com
Contact person for public queries
Name 80631 0
Aniel Jessica leticia Brambila Tapia
Address 80631 0
Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud, Sierra Mojada #950 Colonia Independencia, Guadalajara, Jalisco México
Country 80631 0
Mexico
Phone 80631 0
+52 3310941782
Fax 80631 0
Email 80631 0
anieljessica@hotmail.com
Contact person for scientific queries
Name 80632 0
Aniel Jessica leticia Brambila Tapia
Address 80632 0
Departamento de Psicología Básica, Centro Universitario de Ciencias de la Salud, Sierra Mojada #950 Colonia Independencia, Guadalajara, Jalisco México
Country 80632 0
Mexico
Phone 80632 0
+52 3310941782
Fax 80632 0
Email 80632 0
anieljessica@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all the individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal or for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Explore (NY). 2020 Oct 13;S1550-8307(20)30314-1. ... [More Details]

Documents added automatically
No additional documents have been identified.