Diagnosis, Dual (Psychiatry)PAI-DNCT04442776
Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis
A study testing D-AIP in people with Diagnosis, Dual (Psychiatry), run by Cardenal Herrera University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis, Dual (Psychiatry)
- What is being tested?
- D-AIP
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intellectually Disabled
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of a Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis Admitted to a Psychiatric Hospitalization Unit
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.
Read the 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)
- Being tested
- D-AIP
- Keywords
- Psychiatric Dual Diagnosis, Integrated Attention, Program
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-AIPBehavioural
Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Change Readiness
Assessed by Questionnaire SOCRATES 8D
Measured: 12 months
Insight
Assessed by Scale Unawareness of Mental Disorders (SUMD)
Measured: 12 months
Medication Adherence
Assessed by Medication Adherence Scale (MMAS-8)
Measured: 12 months
Therapeutic Alliance
Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)
Measured: 2-3 months
Anxiety
Assessed by Hamilton Anxiety Rating Scale (HARS)
Measured: 12 months
Hopelessness
Assessed by Hopelessness Scale (HS)
Measured: 12 months
Secondary outcomes (4)
Containments methods
Number of registered containments methods
Measured: 2-3 months
Drug use change
Presence of drug abuse through a urine sample with "10-panel drug test"
Measured: 12 months
Hospital readmissions
Number of registered hospital readmissions
Measured: 12 months
Dual diagnosis knowledge
Assessed by ad-hoc questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, Dual (Psychiatry)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (Parallel Assignment)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montse Cañabate, Cardenal Herrera University
- Investigators
- Montse Cañabate, Dra., Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442776
- Sponsor's protocol ID
- Study DAIP
- Other IDs
- ESTUDIO PAI-D
- Acronym
- PAI-D
- Status last verified
- Jun 2020
- First submitted
- 20 Feb 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Dual Integrated Attention Program (DAIP) in People With Severe Dual Diagnosis Admitted to a Psychiatric Hospitalization Unit
- ClinicalTrials.gov ID
- NCT04442776
- Acronym / sponsor ID
- PAI-D / Study DAIP
- Conditions
- Diagnosis, Dual (Psychiatry)
- Keywords
- Psychiatric Dual Diagnosis, Integrated Attention, Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (Parallel Assignment)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: D-AIPThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatients diagnosed with some serious mental illness of the following:
- Consumption of addictive substances
Key exclusion criteria (1 listed)
- Intellectually Disabled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-AIPIntervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety | Behavioural | Intervention group |
Primary outcome
Stages of Change Readiness
Time frame: 12 months
Assessed by Questionnaire SOCRATES 8D
Insight
Time frame: 12 months
Assessed by Scale Unawareness of Mental Disorders (SUMD)
Medication Adherence
Time frame: 12 months
Assessed by Medication Adherence Scale (MMAS-8)
Therapeutic Alliance
Time frame: 2-3 months
Assessed by Working Alliance Inventory in patients and therapist (WAI-P and WAI-T)
Anxiety
Time frame: 12 months
Assessed by Hamilton Anxiety Rating Scale (HARS)
Hopelessness
Time frame: 12 months
Assessed by Hopelessness Scale (HS)
4 secondary outcomes
Containments methods
Time frame: 2-3 months
Drug use change
Time frame: 12 months
Hospital readmissions
Time frame: 12 months
Dual diagnosis knowledge
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montse Cañabate, Dra. principal investigator
Cardenal Herrera University
Questions about this trial
What is this clinical trial studying?
A study testing D-AIP in people with Diagnosis, Dual (Psychiatry), run by Cardenal Herrera University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Montse Cañabate, Dra. (+34-601-209-435, montserrat.canabate@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of Change Readiness (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.