Mental Health DisorderNCT04272541
Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder
A study testing Psychoeducation program and Psychopharmacology intervention in people with Mental Health Disorder and Healthy Lifestyle, run by Universidad de Granada at 1 site in Spain.
Trial summary
Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Mental Health Disorder, Healthy Lifestyle
- What is being tested?
- Psychoeducation program and Psychopharmacology intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2020to 20 Nov 2020
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 40 years old,
- A body mass index higher than 30
- Psychopathologically stabilized
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness
Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.
Read the detailed description
It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.
- Conditions
- Mental Health Disorder, Healthy Lifestyle
- Being tested
- Psychoeducation program, Psychopharmacology intervention
- Keywords
- cardiovascular risk, metabolic syndrome, independency, psychopathology
- Medical subject headings
- Mental Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation programBehavioural
Also called Mixed treatment program
Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.
Psychopharmacology interventionDrug
Also called Standard intervention
Intervention program consisted of psychopharmacology. This will be executed during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation program | Active comparator | The intervention program consists of psychopharmacology (standard intervention in mental health services) + individual psychoeducation (individual treatment including learning of Healthy Lifestyle). This program is implemented for three months, allocated in several sessions. Receives: Behavioral: Psychoeducation program |
| Habitual intervention | Active comparator | Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months. Receives: Drug: Psychopharmacology intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
This measurement registers weight in Kg
Measured: Change from Baseline in weight at 3 and 6 months
Secondary outcomes (5)
waist circumference
This measurement registers waist circumference in cm
Measured: Change from Baseline in waist circumference at 3 and 6 months
waist-hip ratio
Waist-hip ratio will be calculated
Measured: Change from Baseline in waist-hip ratio at 3 and 6 months
Framingham scale
The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
Measured: Change from Baseline in Framingham scale at 3 and 6 months
Global Assesment of funtioning Scale
This scale evaluates psychological, social, and occupational functioning dimensions on a hypothetical continuum of mental health-illness.
Measured: Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months
PANNS
The Positive and Negative Syndrome Scale for mental disorder
Measured: Change from Baseline in PANNS at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Feb 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
- Investigators
- José Manuel Pérez Mármol, PhD, Principal investigator, Department of Physiotherapy. Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272541
- Sponsor's protocol ID
- NCT04272541
- Status last verified
- Jul 2021
- First submitted
- 13 Feb 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT04272541
- Acronym / sponsor ID
- NCT04272541
- Conditions
- Mental Health Disorder, Healthy Lifestyle
- Keywords
- cardiovascular risk, metabolic syndrome, independency, psychopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 17 Feb 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.
Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.
Detailed description
It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation program | Active comparator | Behavioral: Psychoeducation programThe intervention program consists of psychopharmacology (standard intervention in mental health services) + individual psychoeducation (individual treatment including learning of Healthy Lifestyle). This program is implemented for three months, allocated in several sessions. |
| Habitual intervention | Active comparator | Drug: Psychopharmacology interventionIntervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 40 years old,
- A body mass index higher than 30
- Psychopathologically stabilized
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| Psychoeducation programAlso: Mixed treatment programIntervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions. | Behavioural | Psychoeducation program |
| Psychopharmacology interventionAlso: Standard interventionIntervention program consisted of psychopharmacology. This will be executed during 3 months. | Drug | Habitual intervention |
Primary outcome
weight
Time frame: Change from Baseline in weight at 3 and 6 months
This measurement registers weight in Kg
5 secondary outcomes
waist circumference
Time frame: Change from Baseline in waist circumference at 3 and 6 months
waist-hip ratio
Time frame: Change from Baseline in waist-hip ratio at 3 and 6 months
Framingham scale
Time frame: Change from Baseline in Framingham scale at 3 and 6 months
Global Assesment of funtioning Scale
Time frame: Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months
PANNS
Time frame: Change from Baseline in PANNS at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
José Manuel Pérez Mármol, PhD principal investigator
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation program and Psychopharmacology intervention in people with Mental Health Disorder and Healthy Lifestyle, run by Universidad de Granada at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: Change from Baseline in weight at 3 and 6 months). 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 7 Jul 2021.