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

Cardenal Herrera University

Status: Unknown

Conditions: Diagnosis, Dual (Psychiatry)

Treatments: Behavioral: D-AIP

Study type: Interventional

Funder types: Other

Identifiers

NCT04442776

Study DAIP

ESTUDIO PAI-D (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: D-AIP

Control group

No Intervention group

Description:

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