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

NCT ID: NCT04442776

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-05-01

Brief 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.

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.

Conditions

Diagnosis, Dual (Psychiatry)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

D-AIP

Intervention Type: BEHAVIORAL

Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

D-AIP

Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Montse Cañabate

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Montse Cañabate, Dra.

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Central Contacts

Montse Cañabate, Dra.

Role: CONTACT

montserrat.canabate@uchceu.es

+34-601-209-435

Other Identifiers

ESTUDIO PAI-D

Identifier Type: OTHER

Identifier Source: secondary_id

Study DAIP

Identifier Type: -

Identifier Source: org_study_id