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临床试验/NCT04442776
NCT04442776Unknown不适用

Validation of a Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis Admitted to a Psychiatric Hospitalization Unit

Cardenal Herrera University0 个研究点目标入组 86 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
86
主要终点
Anxiety

研究概览

简要总结

Aim: validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit

Design: Randomized Controlled Trial. Population: Inpatients with dual diagnosis.

详细描述

The main objective of the project is to validate a Dual Integrated Attention Program (D-AIP) for mental health nursing in people with Severe Dual Diagnosis admitted to a psychiatric hospitalization unit, assessing change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety, which this context generates. For this purpose, a randomized, prospective, one-year-longitudinal clinical trial will be conducted. This study will be applied on patients with diagnosis of schizophrenia, schizoaffective disorder and bipolar disorder types I and II who, after accepting to participate in the study and signing the informed consent, answer the PRISM questionnaire of admission in the hospitalization unit and fulfill the dual pathology criteria. After, they will be randomized in control group and intervention group (only the later will complete the D-AIP).

The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made. In both groups, a different person from the one who performs the intervention and without knowledge of the group belonging will assess them with questionnaires in 9 moments during the whole follow-up year (Socrates 8D, Scale of Unawareness of Mental Disorder "SUMD", Morisky Medication Adherence Scale "MMAS-8", Working Alliance Inventory "WAI", Hamilton Anxiety Rating Scale "HARS" y Hopelessness Scale "HS") and will collect a urine sample in each evaluation. The sample size will be 86 subjects, for α=0.05 and power=0.80.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Inpatients diagnosed with some serious mental illness of the following:
  • •Inpatients with diagnosis of schizophrenia
  • •Inpatients with diagnosis schizoaffective disorder
  • •Inpatients with diagnosis bipolar disorder types I
  • •Inpatients with diagnosis bipolar disorder types II
  • •Consumption of addictive substances

排除标准

  • •Intellectually Disabled

研究组 & 干预措施

Intervention group

Experimental

The intervention group will complete the Dual Integrated Attention Program (D-AIP) The D-AIP will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made.

干预措施: D-AIP (Behavioral)

Control group

No Intervention

The control group will complete the usual treatment. One session per day voluntary during admission and discharge, nursing consultations only to put injectable medication

结局指标

主要结局

Anxiety

时间窗: 12 months

Assessed by Hamilton Anxiety Rating Scale (HARS)

Stages of Change Readiness

时间窗: 12 months

Assessed by Questionnaire SOCRATES 8D

Insight

时间窗: 12 months

Assessed by Scale Unawareness of Mental Disorders (SUMD)

Medication Adherence

时间窗: 12 months

Assessed by Medication Adherence Scale (MMAS-8)

Therapeutic Alliance

时间窗: 2-3 months

Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)

Hopelessness

时间窗: 12 months

Assessed by Hopelessness Scale (HS)

次要结局

  • Dual diagnosis knowledge(12 months)
  • Hospital readmissions(12 months)
  • Containments methods(2-3 months)
  • Drug use change(12 months)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Montse Cañabate

Principal Investigator

Cardenal Herrera University

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