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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04442776
Acronym
PAI-D
Enrollment
86
Registered
2020-06-23
Start date
2020-09-01
Completion date
2023-05-01
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Dual (Psychiatry)

Keywords

Psychiatric Dual Diagnosis, Integrated Attention, Program

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.

Interventions

BEHAVIORALD-AIP

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

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized Controlled Trial (Parallel Assignment)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hopelessness12 monthsAssessed by Hopelessness Scale (HS)
Insight12 monthsAssessed by Scale Unawareness of Mental Disorders (SUMD)
Medication Adherence12 monthsAssessed by Medication Adherence Scale (MMAS-8)
Therapeutic Alliance2-3 monthsAssessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)
Anxiety12 monthsAssessed by Hamilton Anxiety Rating Scale (HARS)
Stages of Change Readiness12 monthsAssessed by Questionnaire SOCRATES 8D

Secondary

MeasureTime frameDescription
Drug use change12 monthsPresence of drug abuse through a urine sample with 10-panel drug test
Hospital readmissions12 monthsNumber of registered hospital readmissions
Dual diagnosis knowledge12 monthsAssessed by ad-hoc questionnaire
Containments methods2-3 monthsNumber of registered containments methods

Contacts

Primary ContactMontse Cañabate, Dra.
montserrat.canabate@uchceu.es+34-601-209-435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026