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临床试验/NCT02536924
NCT02536924Unknown不适用

Randomized Control Trial of RESOLVE (Relaxation Exercise, SOLving Problem and cognitiVe Errors): A Waiting Room Intervention for Crisis Clients

Queen's University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

Crisis Teams are now a well established part of the mental health system. These teams are effective in providing crisis management, treatment, referral, and educational services. We are testing a waiting room intervention for the patients attending a Crisis Team. As far as we are aware, no trial of a waiting room intervention has been reported in a psychiatric setting. This is a preliminary study using a Randomized Control Trial (RCT) Design. Patients (N =40) will be randomly allocated to either the treatment or the control group, and will be selected from the local Crisis Team. The treatment group will receive a waiting room intervention called, RESOLVE (Relaxation, SOLving problem and cognitiVe Errors), that is a short film, Plus Treatment As Usual (TAU), and the control group will receive only TAU. Patients in both groups will be assessed before and after the intervention, using the HADS (Hospital Anxiety And Depression Scale), CORE (Clinical Outcome in Routine Evaluation), (to measure psychopathology) and WHODAS (World Health Organization Disability Assessment Schedule) (for functioning). We hypothesize that the treatment group will demonstrate significant improvement in mental health and functioning, compared to the control group. Analyses will be conducted using SPSS v22, and will consist of a t-test or Chi Square test to measure the baseline differences, and a linear regression to compare the differences between the two groups at the end of the intervention. Results will be published in international journals and will be presented in local and international conferences.

详细描述

GRANT APPLICATION The mental health crisis teams are now a well established and vital part of the mental health system. These teams are uniquely equipped to provide front-line mental health care when and where it is most needed. It is able to provide on-site assessment, crisis management, treatment, referral, and educational services to patients, families, law enforcement officers, and the community at large. Mental health crisis teams provide access to mental health care for even the most under-served populations efficiently and cost-effectively. The cost-effectiveness of the team's services is defined by savings in both monetary and human terms (Zealberg, Santos, & Fisher, 1993) (Scott, 2000). However, no interventions have been developed, that are specific to this service.

Patients attending the crisis teams usually wait for their appointments, just like other health settings. This can be a valuable time that can be used to deliver short term educational interventions. This has been tried and tested in general health settings (Coyne, Palmer, Shapiro, Thompson, & DeMichele, 2004; Holmes-Garrett, 1990; Oermann, n.d.; Rhodes et al., 2001; Wheeler et al., 2001). As far as we are aware no waiting room interventions have been tried or tested in psychiatric setup. We have developed an intervention RESOLVE (Relaxation Exercise, SOLving problem and cognitiVe Errors), that can be easily delivered using eMedia (for example a tv screen) in waiting room. This intervention is short enough to be given while patients are in a waiting room in a psychiatric clinic. A crisis team setting might be ideal as most patients might find a problem solving approach helpful. We want to conduct a pilot using a Randomised Controlled Trial design (RCT) to assess effectiveness of this intervention.

METHODS Objectives The primary objective of this preliminary pilot study is to assess the effectiveness of a "waiting room intervention" for patients attending a crisis clinic. The objectives of the study are to see if the intervention can reduce (1) symptoms of depression and anxiety, (2) overall psychopathology, and (3) disability.

Participants Participants (N =40) will be primarily recruited from the Crisis Clinic in Kingston. Inclusion criteria are; All those who fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC, are between the ages of 18 to 65. Patients will be asked to attend a further appointment at the end of study period and will be assessed again. The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis. Data will be kept strictly confidential, available only to the primary investigators. Participants may withdraw from the study at any time without penalties.

Study design This preliminary evaluation will use a Randomized Control Trial (RCT) design. Randomization will be performed using www.randomization.com, from the list of all the patients who consent. Study participants will be randomly assigned to either treatment or the control arm. The treatment group will receive waiting room intervention plus TAU (Treatment As Usual), while the control group will receive only TAU. Patients who have been referred for the study will be provided brief information about the study. Those who meet the criteria and consent will be then asked to join the study and will be allocated to one arm of the trial after randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All those who fulfill the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4) using ICD10 RDC
  • •between the ages of 18-65
  • •must meet the assessment criteria at the beginning and the end of the study period

排除标准

  • •excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence)
  • •significant cognitive impairment (for example learning disability or dementia)
  • •active psychosis

研究组 & 干预措施

Waiting room intervention plus TAU

Experimental

The treatment group will receive waiting room intervention plus treatment as usual.

干预措施: Waiting Room Intervention (Behavioral)

Waiting room intervention plus TAU

Experimental

The treatment group will receive waiting room intervention plus treatment as usual.

干预措施: Treatment as usual. (Behavioral)

Only TAU.

Experimental

The control group will receive only treatment as usual.

干预措施: Treatment as usual. (Behavioral)

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: 6 months

14 item, self assessment scale designed to measure anxiety and depression.

次要结局

  • The Clinical Outcome in Routine Evaluation (CORE)(6 months)
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Farooq Naeem

Principal Investigator

Queen's University

研究点 (1)

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