Psychotic DisordersNCT05012709
A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention
A study testing multisensory stimulation therapy in people with Psychotic Disorders and Anxiety, run by Jianan Psychiatric Center, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT). Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychotic Disorders, Anxiety, Complementary Therapies
- What is being tested?
- multisensory stimulation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2012to 10 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitalized patients
- diagnosed with schizophrenia, schizophreniform disorder, and schizoaffective disorder for more than 5 years according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association, 2013).
- aged above 20 years old
Who cannot join
- had a history of alcohol and drug abuse
- could not concentrate on activities for at least 30 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Healthy Care Environment in Psychiatry: A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention
Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT).
Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa. The CONSORT checklist for RCT was reported. Psychotic symptoms, emotional reactions, behavioral relaxation responses and heart rates were assessed at 6 time points.
Read the detailed description
This was a prospective randomized controlled trial with parallel groups following the Consolidated Standards of Reporting Trials and was approved by the Institutional Review Board of Jianan Mental Health Hospital (approval number Taiwan Nurses Association-1012023/ 12-002). Informed consent was obtained from all the subjects. Patients who had been hospitalized for schizophrenia, schizophreniform disorder, and schizoaffective disorder for more than 5 years according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association, 2013) criteria were eligible to participate in the study. Patients who had a history of alcohol and drug abuse or could not concentrate on activities for at least 30 minutes were excluded from the study. As shown in the CONSORT diagram (Schulz et al., 2010), 109 patients were screened, 95 participants were enrolled by a research assistant and received interventions delivered by a nurse researcher. In the end, total 90 participants completely received multi-sensory stimulation therapy in a psychiatry institution in Southern Taiwan. None of the adverse events occurred. All patients were initially randomly assigned to either intervention or treatment as usual (TAU) group using a computer-generated random allocation sequence. The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffusers, music…etc.. The TAU group received usual routine care. After receiving either intervention or routine care, there was a 2-week washout period to clear the residual effects from the initial assigned group activities. Patients were then crossover into the other group where the process started over. Symptoms were assessed at baseline (T0), after the 1st session (T1), the 3rd session (T2) and the 6th session (T3). No important changes to the methods or trial outcomes were made after trial commencement.
Sample Size Calculation:
Sample size was calculated based on showing between group outcome differences after receiving MST according to a previous study (Cheng et al., 2017) of 60 patients who underwent the same comprehensive protocol. To achieve statistical significance p< 0.05, each parallel group of our study required at least 30 patients.
All the outcome assessments were by original assigned groups. Descriptive analysis was conducted for analyzing demographics and outcomes in all time points. Repeated Measurement of Analysis of Variance (ANOVA) was used to examine the effectiveness of MST between experimental and control groups. Effect size was determined using partial η2 that reflects the percentage of the variance in outcome variables explained by the independent variables.
- Conditions
- Psychotic Disorders, Anxiety, Complementary Therapies, Clinical Trial
- Being tested
- multisensory stimulation therapy
- Medical subject headings
- Psychotic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multisensory stimulation therapyBehavioural
The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on. Receives: Behavioral: multisensory stimulation therapy |
| control group | No intervention | The TAU group received usual routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Psychiatric Symptoms
Brief Psychiatric Rating Scale (BPRS) consists of a series of 18 items that are used to assess the following psychotic symptoms: somatic concern, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement, and disorientation (Overall and Gorham, 1962). The total score range is between 0 (not present) and 18 (extremely severe). The reliability of BPRS in this study was acceptable (Cronbach's α = 0.71).
Measured: Change from baseline BPRS at the sixth sessions (each session is 7 days).
Change of Anxiety
The Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) includes seven items. Each item is evaluated on a four-point (0 to 3) scale, with a total possible score range of 0 to 21. Scores of eight and higher indicate the possible presence of anxiety. The reliability of HADS-A in this study was acceptable (Cronbach's α = 0.67).
Measured: Change from baseline HADS-A at the sixth sessions (each session is 7 days).
Change of Behavioral Relaxation
Behavioral Relaxation Scale (BRS) was administered to measure the motor elements of relaxation through observations of voluntary muscles by trained clinicians. Ten dimensions of postures were observed (e.g. breath, shoulders, hands… etc.) and behaviors were checked for indications of relaxation. The total score range of the BRS is between 0 (no relaxation) and 10 (relaxation).
Measured: Change from baseline BRS at the sixth sessions (each session is 7 days).
Change of physiological responses
Patients' Heart Rate, as an indicator of their responses to stress and tension, was measured by a wireless biofeedback system (MindMedia, Herten). The data was collected at a rate of 400 importing signals every minute.
Measured: Change from baseline heart rate at the sixth sessions (each session is 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Mar 2012
- Primary completion10 Jan 2013
- Study completion10 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianan Psychiatric Center, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Nurses Association, National Cheng Kung University
- Responsible party
- Principal investigator, Mei-Feng Lin, Jianan Psychiatric Center, Ministry of Health and Welfare
- Investigators
- Mei-Feng Lin, PhD, Study chair, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012709
- Sponsor's protocol ID
- JiananPsych
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared with other research teams.
Publications
American Psychiatric Association. (2013). Quick reference to the diagnostic criteria from DSM-V (p. 370). Washington, DC: APA.
Overall, J. E., & Gorham, D. R. (1962). The brief psychiatric rating scale. Psychological reports, 10(3), 799-812. https://doi.org/10.2466%2Fpr0.1962.10.3.799
Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Michultka DM, Poppen RL, Blanchard EB. Relaxation training as a treatment for chronic headaches in an individual having severe developmental disabilities. Biofeedback Self Regul. 1988 Sep;13(3):257-66. doi: 10.1007/BF00999174.
PubMed 3067751Cheng SC, Hsu WS, Shen SH, Hsu MC, Lin MF. Dose-Response Relationships of Multisensory Intervention on Hospitalized Patients With Chronic Schizophrenia. J Nurs Res. 2017 Feb;25(1):13-20. doi: 10.1097/jnr.0000000000000154.
PubMed 27310606Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.
PubMed 31012939Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
PubMed 20334632
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Healthy Care Environment in Psychiatry: A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention
- ClinicalTrials.gov ID
- NCT05012709
- Acronym / sponsor ID
- JiananPsych
- Conditions
- Psychotic Disorders, Anxiety, Complementary Therapies, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Jianan Psychiatric Center, Ministry of Health and WelfareUniversity, hospital or other
- Collaborators
- Taiwan Nurses Association, National Cheng Kung University
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 10 Jan 2013 (actual)
- Study completion
- 10 Mar 2013 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Design: This parallel randomized controlled trial (RCT) was conducted according to the Consolidated Standards of Reporting Trials (CONSORT).
Methods: In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa. The CONSORT checklist for RCT was reported. Psychotic symptoms, emotional reactions, behavioral relaxation responses and heart rates were assessed at 6 time points.
Detailed description
This was a prospective randomized controlled trial with parallel groups following the Consolidated Standards of Reporting Trials and was approved by the Institutional Review Board of Jianan Mental Health Hospital (approval number Taiwan Nurses Association-1012023/ 12-002). Informed consent was obtained from all the subjects. Patients who had been hospitalized for schizophrenia, schizophreniform disorder, and schizoaffective disorder for more than 5 years according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association, 2013) criteria were eligible to participate in the study. Patients who had a history of alcohol and drug abuse or could not concentrate on activities for at least 30 minutes were excluded from the study. As shown in the CONSORT diagram (Schulz et al., 2010), 109 patients were screened, 95 participants were enrolled by a research assistant and received interventions delivered by a nurse researcher. In the end, total 90 participants completely received multi-sensory stimulation therapy in a psychiatry institution in Southern Taiwan. None of the adverse events occurred. All patients were initially randomly assigned to either intervention or treatment as usual (TAU) group using a computer-generated random allocation sequence. The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffusers, music…etc.. The TAU group received usual routine care. After receiving either intervention or routine care, there was a 2-week washout period to clear the residual effects from the initial assigned group activities. Patients were then crossover into the other group where the process started over. Symptoms were assessed at baseline (T0), after the 1st session (T1), the 3rd session (T2) and the 6th session (T3). No important changes to the methods or trial outcomes were made after trial commencement.
Sample Size Calculation:
Sample size was calculated based on showing between group outcome differences after receiving MST according to a previous study (Cheng et al., 2017) of 60 patients who underwent the same comprehensive protocol. To achieve statistical significance p< 0.05, each parallel group of our study required at least 30 patients.
All the outcome assessments were by original assigned groups. Descriptive analysis was conducted for analyzing demographics and outcomes in all time points. Repeated Measurement of Analysis of Variance (ANOVA) was used to examine the effectiveness of MST between experimental and control groups. Effect size was determined using partial η2 that reflects the percentage of the variance in outcome variables explained by the independent variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In total, 90 patients were randomly assigned to either the intervention or the control group. After a 2-week washout period, the intervention group was reassigned to the control and vice versa.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: multisensory stimulation therapyThe intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on. |
| control group | No intervention | –The TAU group received usual routine care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized patients
- diagnosed with schizophrenia, schizophreniform disorder, and schizoaffective disorder for more than 5 years according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association, 2013).
- aged above 20 years old
Key exclusion criteria (2 listed)
- had a history of alcohol and drug abuse
- could not concentrate on activities for at least 30 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multisensory stimulation therapyThe intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on. | Behavioural | intervention group |
Primary outcome
Change of Psychiatric Symptoms
Time frame: Change from baseline BPRS at the sixth sessions (each session is 7 days).
Brief Psychiatric Rating Scale (BPRS) consists of a series of 18 items that are used to assess the following psychotic symptoms: somatic concern, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement, and disorientation (Overall and Gorham, 1962). The total score range is between 0 (not present) and 18 (extremely severe). The reliability of BPRS in this study was acceptable (Cronbach's α = 0.71).
Change of Anxiety
Time frame: Change from baseline HADS-A at the sixth sessions (each session is 7 days).
The Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) includes seven items. Each item is evaluated on a four-point (0 to 3) scale, with a total possible score range of 0 to 21. Scores of eight and higher indicate the possible presence of anxiety. The reliability of HADS-A in this study was acceptable (Cronbach's α = 0.67).
Change of Behavioral Relaxation
Time frame: Change from baseline BRS at the sixth sessions (each session is 7 days).
Behavioral Relaxation Scale (BRS) was administered to measure the motor elements of relaxation through observations of voluntary muscles by trained clinicians. Ten dimensions of postures were observed (e.g. breath, shoulders, hands… etc.) and behaviors were checked for indications of relaxation. The total score range of the BRS is between 0 (no relaxation) and 10 (relaxation).
Change of physiological responses
Time frame: Change from baseline heart rate at the sixth sessions (each session is 7 days).
Patients' Heart Rate, as an indicator of their responses to stress and tension, was measured by a wireless biofeedback system (MindMedia, Herten). The data was collected at a rate of 400 importing signals every minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- BackgroundAmerican Psychiatric Association. (2013). Quick reference to the diagnostic criteria from DSM-V (p. 370). Washington, DC: APA.
- BackgroundOverall, J. E., & Gorham, D. R. (1962). The brief psychiatric rating scale. Psychological reports, 10(3), 799-812. https://doi.org/10.2466%2Fpr0.1962.10.3.799
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Background: PubMed 3067751Michultka DM, Poppen RL, Blanchard EB. Relaxation training as a treatment for chronic headaches in an individual having severe developmental disabilities. Biofeedback Self Regul. 1988 Sep;13(3):257-66. doi: 10.1007/BF00999174.
- Background: PubMed 27310606Cheng SC, Hsu WS, Shen SH, Hsu MC, Lin MF. Dose-Response Relationships of Multisensory Intervention on Hospitalized Patients With Chronic Schizophrenia. J Nurs Res. 2017 Feb;25(1):13-20. doi: 10.1097/jnr.0000000000000154.
- Background: PubMed 31012939Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.
- Background: PubMed 20334632Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
- Individual participant dataSharing planned: No. Not shared with other research teams.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Feng Lin, PhD study chair
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multisensory stimulation therapy in people with Psychotic Disorders and Anxiety, run by Jianan Psychiatric Center, Ministry of Health and Welfare at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Psychiatric Symptoms (time frame: Change from baseline BPRS at the sixth sessions (each session is 7 days).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05012709, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.