Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012837102254 Date of Approval: 04/12/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of knowledge of individualised Sensory Processing techniques on the Occupational Performance of adults with major affective disorders: a randomised basic experimental study.
Official scientific title The effect of knowledge of individualised Sensory Processing techniques on the Occupational Performance of adults with major affective disorders: a randomised basic experimental study.
Brief summary describing the background and objectives of the trial Sensory Integration is a significant area of practice for Occupational Therapists internationally. Although techniques are most commonly applied in children, there is some evidence to support their use with adults. This evidence base needs to be increased. Sensory processing difficulties have a significant impact on the performance of adults with major affective disorders, including anxiety and depression. During routine occupations, mental distress can be caused when the sensory experiences does not match your expectations. It is important to develop interventions that address sensory needs to improve occupational participation and engagement. This study investigates the effect of knowledge of a person's unique sensory profile and recommended sensory processing techniques on occupational performance and level of disability over 12 weeks following discharge from a private mental health clinic, in comparison to people receiving usual care. The intervention group will complete the online Sensory Matrix (TM), with a follow up occupational therapy consultation to explain the results of this assessment in achieving personalised goals identified using the Canadian Occupational Performance Measure (COPM). The intervention occurs in the week post-discharge for treatment of a major affective disorder, with follow-up assessment at 12 weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 13/01/2019
Actual trial start date 10/02/2019
Anticipated date of last follow up 28/06/2019
Actual Last follow-up date 01/09/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 27
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care Daily occupational therapy groups while admitted to the clinic. Both the control group and the experimental group receive the usual care at the clinic. For the duration of hospitalization. Usual care at the private mental health group clinics consists of a multi-disciplinary team approach. Patients are hospitalised to maximum of 21 days or according to medical aid funds available. During their in-hospital stay they have regular appointments with their psychiatrist and their psychologist, and their progress is monitored, and medication administered by the nursing staff. All patients are encouraged to participate in the ward program run by the occupational therapists working at the clinic. The group programme is coordinated by the occupational therapy group practice manager and is discussed at group practice meetings by the therapists working at the different clinics and to ensure consistency in level of care. The program is the same at all three clinics. Occupational therapy groups are psycho-educational groups, psycho-social craft groups and relaxation groups. In the morning, two psycho-educational (life skills) groups are presented daily and weekly topics like self-awareness, emotional regulation, communication and relationships, stress management and daily program management are discussed during these groups. Cognitive behaviour therapy (CBT) principles and mindfulness principles are used during life skill discussion groups. In the afternoon, one daily psycho-social craft group are presented followed by a relaxation therapy group. Groups are one hour each and presented from Monday to Friday each week. On Saturdays, only two psycho-social craft groups are presented. After discharge, clients have follow-up appointments with their psychiatrist and psychologist as needed. Usual care does not include any occupational therapy follow-up when clients are discharged from the clinic. 13 Active-Treatment of Control Group
Experimental Group Sensory Matrix Knowledge intervention. Once off individual session where the Sensory Matrix was completed online and an individualized report was discussed with the client. The knowledge was obtained from the computer generated report and the need for adding or reducing sensory stimuli according to the client's report was then discussed by the researcher, an occupational therapist trained in using the Sensory Matrix.. 90 minutes A 90-minute once off appointment for a face-to-face session, was made within the first week after the pre-test. The intervention was conducted by the researcher, an occupational therapist with 19 years’ experience as a clinician in this field and a University clinical supervisor. The researcher is trained in Ayres Sensory Integration and trained by the developer of the Sensory Matrix™ as user. The intervention took place in a consultation room at the clinic where the client was admitted to. During the first 15-20 minutes of the appointment, the client completed the Sensory Matrix™, a sensory questionnaire, online on a research laptop (www.sensoryintelligence.co.za). The client received their unique username and password and basic instructions to complete the Sensory Matrix™ and for confidentiality purposes, a pseudo name, number and e-mail address was typed into the system. The participant completed the Sensory Matrix™ online, where after a computer-generated report was sent to the researcher within a few minutes after submitting the questionnaire. An electronic copy of the Sensory Matrix™ report was sent to the participant to refer to. The individualized report was then discussed with the participant in detail, allowing time for questions. Discussion consisted of reading the report with the participant and explaining basic neurological thresholds according to the Sensory Tree™ analogy. Only the information given in the report was discussed using the explanation of needing to add (leaves) or reduce (roots) sensory stimuli according to the results and possible strategies of each sensory system indicated in the report. General strategies at home and at work were discussed at the end of the report according to all sensory systems combined. 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults between the ages of 18 and 60 years old. Diagnosed with major affective disorder (depressive disorders, bipolar mood disorders or anxiety disorders). Within the sub-acute phase of treatment with medication stabilized. Admitted to one of the three private mental health group clinics. Stay in the Cape Town district. Employed Can read and understand English. Not be mentally challenged. Not be psychotic or had a psychotic episode on admission. Not be linked to any substance or alcohol abuse. Not be a suicidal risk. Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/06/2018 Health Research Ethics Committee of University of Stellenbosch
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Health Science, University of Stellenbosch, Francie van Zijl drive, Parow, Cape Town. Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/05/2020 Health Research Ethics Committee of University of Stellenbosch HREC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Health Science, University of Stellenbosch, Francie van Zijl drive, Parow, Cape Town Cape Town 7500 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/05/2019 Health Research Ethics Committee of University of Stellenbosch HREC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Health Science, University of Stellenbosch, Francie van Zijl drive, Parow, Cape Town Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Canadian Occupational Performance Measure COPM - Performance and satisfaction with performance. Discharge and 12 weeks posttest
Secondary Outcome Patient Health Questionnaire PHQ-9 for Depression Discharge and 12 weeks post test
Secondary Outcome Level of anxiety according to the Generalized Anxiety Disorder GAD-7 scale. Pre-test before discharge and post test 12 weeks after the pre-test.
Primary Outcome Occupational performance measured according to change in functional disability according to the World Health Organisation Disability Assessment Schedule WHODAS 2.0. Pre-test before discharge and post test 12 weeks after pre-test.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life path health group mental health clinics Syfred Douglas Street, N1 City Cape Town 7463 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Milandi de Villiers 6 High trees road, Eversdal heights, Durbanville Durbanville 7550 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Milandi de Villiers 6 High trees road, Eversdal, Durbanville Durbanville 7550 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Nicola Ann Plastow Faculty of Medicine and Health Science, University of Stellenbosch, Francie van Zijl drive, Parow Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Milandi De Villiers milandi.devilliers@gmail.com 0027828756823 6 High Trees road, Eversdal, Durbanville
City Postal code Country Position/Affiliation
Durbanville 7550 South Africa Masters student
Role Name Email Phone Street address
Public Enquiries Milandi De Villiers milandi.devilliers@gmail.com 0027828756823 6 High Trees road, Eversdal, Durbanville
City Postal code Country Position/Affiliation
Durbanville 7550 South Africa Masters Student
Role Name Email Phone Street address
Scientific Enquiries Nicola Plastow nap@sun.ac.za 0027818313973 Faculty of Medicine and Health Science, University of Stellenbosch, Francie van Zijl drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Study supervisor.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that is anonymised and is related to all of the study outcomes will be made available following publication of the results of this study in a peer-reviewed journal, and approval for such sharing by the Stellenbosch University Health Research Ethics Committee, through contact with the study investigators, for a period of two years after publication. The study protocol is available immediately. Study Protocol 2 years Approval by the Stellenbosch University Health Research Ethics Committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.sun.ac.za/english/faculty/healthsciences/rdsd/Pages/Ethics/Contact-us0715-8777.aspx No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information