NCT04442776

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

February 20, 2020

Last Update Submit

June 19, 2020

Conditions

Keywords

Psychiatric Dual DiagnosisIntegrated AttentionProgram

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (4)

  • Containments methods

    2-3 months

  • Drug use change

    12 months

  • Hospital readmissions

    12 months

  • Dual diagnosis knowledge

    12 months

Study Arms (2)

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.

Behavioral: D-AIP

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

Interventions

D-AIPBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Consumption of addictive substances

You may not qualify if:

  • Intellectually Disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Montse Cañabate, Dra.

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial (Parallel Assignment)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2020

First Posted

June 23, 2020

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2023

Last Updated

June 23, 2020

Record last verified: 2020-06