Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diagnosis, Dual (Psychiatry)

Intervention / Treatment
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* Behavioral: D-AIP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Intellectually Disabled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial (Parallel Assignment)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: D-AIP<br>* Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety<br>|
| No Intervention: Control group<br>The control group will complete the usual treatment. One session per day voluntary during admission and discharge, nursing consultations only to put injectable medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of Change Readiness | Assessed by Questionnaire SOCRATES 8D | 12 months | 
| Insight | Assessed by Scale Unawareness of Mental Disorders (SUMD) | 12 months | 
| Medication Adherence | Assessed by Medication Adherence Scale (MMAS-8) | 12 months | 
| Therapeutic Alliance | Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T) | 2-3 months | 
| Anxiety | Assessed by Hamilton Anxiety Rating Scale (HARS) | 12 months | 
| Hopelessness | Assessed by Hopelessness Scale (HS) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Containments methods | Number of registered containments methods | 2-3 months | 
| Drug use change | Presence of drug abuse through a urine sample with 10-panel drug test | 12 months | 
| Hospital readmissions | Number of registered hospital readmissions | 12 months | 
| Dual diagnosis knowledge | Assessed by ad-hoc questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric Dual Diagnosis, Integrated Attention, Program