Clinical trial NCT04442776: Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis
Official title: Validation of a Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis Admitted to a Psychiatric Hospitalization Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnosis, Dual (Psychiatry)
Keywords: Psychiatric Dual Diagnosis
Integrated Attention
Program
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (Parallel Assignment)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stages of Change Readiness
timeFrame: 12 months
measure: Insight
timeFrame: 12 months
measure: Medication Adherence
timeFrame: 12 months
measure: Therapeutic Alliance
timeFrame: 2-3 months
measure: Anxiety
timeFrame: 12 months
measure: Hopelessness
timeFrame: 12 months
Secondary outcomes:
measure: Containments methods
timeFrame: 2-3 months
measure: Drug use change
timeFrame: 12 months
measure: Hospital readmissions
timeFrame: 12 months
measure: Dual diagnosis knowledge
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cardenal Herrera University
name: Montse Cañabate, Dra.
role: PRINCIPAL_INVESTIGATOR
References: