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| ID | Type | Description | Link |
|---|---|---|---|
| ESTUDIO PAI-D | Other Identifier | AEMPS(Agencia EspaƱola de Medicamentos) |
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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.
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 Ī±=0.05 and power=0.80.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | No Intervention | The control group will complete the usual treatment. One session per day voluntary during admission and discharge, nursing consultations only to put injectable medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-AIP | Behavioral | Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety |
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| 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 |
| 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" |
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Inclusion Criteria:
Inpatients diagnosed with some serious mental illness of the following:
Consumption of addictive substances
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Montse CaƱabate, Dra. | Contact | +34-601-209-435 | montserrat.canabate@uchceu.es |
| Name | Affiliation | Role |
|---|---|---|
| Montse CaƱabate, Dra. | Cardenal Herrera University | Principal Investigator |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized Controlled Trial (Parallel Assignment)
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| 12 months |
| Hospital readmissions | Number of registered hospital readmissions | 12 months |
| Dual diagnosis knowledge | Assessed by ad-hoc questionnaire | 12 months |