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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnosis, Dual (Psychiatry)
• Intervention / Treatment: Behavioral: D-AIP

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montse Cañabate, Dra.; Phone Number: +34-601-209-435; Email: montserrat.canabate@uchceu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Principal Investigator: Montse Cañabate, Dra., Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Psychiatric Dual Diagnosis; Integrated Attention; Program
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: Study DAIP; ESTUDIO PAI-D (Other Identifier: AEMPS(Agencia Española de Medicamentos))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No