Anxiety Clinical Trial
Official title:
Developing a Healthy Care Environment in Psychiatry: A Study of Dose-response Relationship and the Evidence Based Multisensory Stimulation Intervention
Verified date | August 2021 |
Source | Jianan Psychiatric Center, Ministry of Health and Welfare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | March 10, 2013 |
Est. primary completion date | January 10, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - had a history of alcohol and drug abuse - could not concentrate on activities for at least 30 minutes. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mei-Feng, Lin | Tainan |
Lead Sponsor | Collaborator |
---|---|
Jianan Psychiatric Center, Ministry of Health and Welfare | National Cheng Kung University, Taiwan Nurses Association |
Taiwan,
American Psychiatric Association. (2013). Quick reference to the diagnostic criteria from DSM-V (p. 370). Washington, DC: APA.
Cheng 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. — View Citation
Juszczak 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. — View Citation
Michultka 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. — View Citation
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
Schulz 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. — View Citation
Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 a = 0.71). | Change from baseline BPRS at the sixth sessions (each session is 7 days). | |
Primary | 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 a = 0.67). | Change from baseline HADS-A at the sixth sessions (each session is 7 days). | |
Primary | 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). | Change from baseline BRS at the sixth sessions (each session is 7 days). | |
Primary | 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. | Change from baseline heart rate at the sixth sessions (each session is 7 days). |
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