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

Diagnosis, Dual (Psychiatry) Clinical Trial

— PAI-D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04442776
• Other study ID #: Study DAIP
• Secondary ID: ESTUDIO PAI-D
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2020
• Source: Cardenal Herrera University
• Contact: Montse Cañabate, Dra.
• Phone: +34-601-209-435
• Email: montserrat.canabate[@]uchceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Consumption of addictive substances

Exclusion Criteria:

• Intellectually Disabled

Related Conditions & MeSH terms

• Diagnosis, Dual (Psychiatry)

Intervention

Behavioral:
• D-AIP
Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stages of Change Readiness	Assessed by Questionnaire SOCRATES 8D	12 months
Primary	Insight	Assessed by Scale Unawareness of Mental Disorders (SUMD)	12 months
Primary	Medication Adherence	Assessed by Medication Adherence Scale (MMAS-8)	12 months
Primary	Therapeutic Alliance	Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)	2-3 months
Primary	Anxiety	Assessed by Hamilton Anxiety Rating Scale (HARS)	12 months
Primary	Hopelessness	Assessed by Hopelessness Scale (HS)	12 months
Secondary	Containments methods	Number of registered containments methods	2-3 months
Secondary	Drug use change	Presence of drug abuse through a urine sample with "10-panel drug test"	12 months
Secondary	Hospital readmissions	Number of registered hospital readmissions	12 months
Secondary	Dual diagnosis knowledge	Assessed by ad-hoc questionnaire	12 months