PsychosisNCT01783457
e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
A study testing Individual psychoeducation in people with Psychosis, run by Basque Health Service at 6 sites in Spain.
Trial summary
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Individual psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 6 sitesSpain
- Study dates
- Jan 2011to Jun 2015
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who have suffered a first psychotic episode (diagnosis IV-TR) in the last five years,
- age between 18 and 45 years,
- patients who have given written informed consent to participate.
Who cannot join
- patients with a comorbid disorder that interferes with their ability to communicate,
- patients who received psychoeducation previous to inclusion in study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Universidad del País Vasco
Bilbao, Vizcaya, 48940
Hospital Universitario de Bellvitge
Hospitalet Llobregat, Barcelona, 08907
Fundación Clínico Valencia INCLIVA
Valencia, Valencia, 46010
Universidad de Valencia
Valencia, Valencia, 46010
Araba University Hospital-Santiago
Vitoria-Gasteiz, Álava, 01004
About this study
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Read more
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
Read the detailed description
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving the disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
Primary Objective:
- To assess the effectiveness of individual psychoeducation together with telemedicine (telephone assistance) as an adjuvant therapy in the pharmacological treatment of patients with first episode psychosis, regarding functionality of patients and positive and negative symptoms.
Secondary Objectives:
- To analyse certain biological parameters (BDNF and oxidative stress) in both arms (intervention and control) at baseline and during re-assessment (at six months and after completion of treatment).
- To analyse the effectiveness of online training of psychotherapists who will provide psychoeducation to patients with first episode psychosis.
- Conditions
- Psychosis
- Being tested
- Control, Individual psychoeducation
- Keywords
- First psychotic episode, Individual psychoeducation, Telemedicine, BDNF, Oxidative stress
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Usual treatment
Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
Individual psychoeducationOther
Usual treatment + individual psychoeducational programme, consisting of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving.
Programme of sessions available upon request.
| Study group | Role | What they receive |
|---|---|---|
| Individual psychoeducation | Experimental | Usual treatment + individual psychoeducational intervention (14 sessions). The psychoeducational programme consists of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving. Receives: Other: Individual psychoeducation |
| Control | Active comparator | Usual treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis of patients.
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.
Measured: 6 months
Secondary outcomes (4)
Score on clinical scales assessing functionality.
To assess the effectiveness of individual psychoeducation together with telemedicine (telephone assistance) as an adjuvant therapy in the pharmacological treatment of patients with first episode psychosis, using different scales for clinical assessment of FUNCTIONALITY (Positive and Negative Syndrome Scale (PANSS), SUMD, Morisky-Green Scale, STAI, Hamilton Rating scale for Depression, LSAS, WHOQOL-BREF, EuroQoL) and PROGNOSIS (Strauss Carpenter Scale, GAF, Functional Assessment Staging Test-FAST).
Measured: 6 months
Score of participating psychotherapists on a specific test after online training.
To analyse the effectiveness of online training of psychotherapist who will provide psychoeducation to patients, all therapists carried out a specific tests after each one of the sessions to confirm if they had delivered the session as specified in the protocol.
Measured: 6 months
Biological Parameters: blood levels of BDNF.
To analyse BDNF biological parameter at baseline and during re-assessment at six months (after completion of treatment): BDNF levels in plasma will be measured by ELISA techniques with a kit based on the Sandwich technique used according to the manufacturer´s instructions (CYT306 from Chemicon). The standard curves will be characterised using plasma duplicates and the absorption determined with a microplate reader (BIO-TEK, Sinergy HT) using a wavelength of 450 nm.
Measured: 6 months
Biological Parameters: levels oxidative stress indicators in blood.
To analyse OXIDATIVE STRESS indicators at baseline and during re-assessment at six months (after completion of treatment): Levels of the following OXIDATIVE STRESS INDICATORS will be measured in red blood cell haemolysates: lipid peroxidation (TBARS), nitrites and superoxide dismutase enzyme, total antioxidant ability, glutathione peroxidase and catalase.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Ana María González-Pinto, Basque Health Service
- Investigators
- Patricia Vega, Psychologist, Study chair, Santiago Hospital - Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783457
- Sponsor's protocol ID
- PsychEd-FEP
- Status last verified
- Jan 2016
- First submitted
- 23 Jan 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barbeito S, Vega P, Ruiz de Azua S, Balanza-Martinez V, Colom F, Lorente E, Luengo A, Cerrillo E, Crespo JM, Gonzalez Pinto A. Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial. Trials. 2014 Oct 27;15:416. doi: 10.1186/1745-6215-15-416.
PubMed 25348346
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
- ClinicalTrials.gov ID
- NCT01783457
- Acronym / sponsor ID
- PsychEd-FEP
- Conditions
- Psychosis
- Keywords
- First psychotic episode, Individual psychoeducation, Telemedicine, BDNF, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Carlos III Health Institute
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- 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.
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
Detailed description
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving the disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
Primary Objective:
- To assess the effectiveness of individual psychoeducation together with telemedicine (telephone assistance) as an adjuvant therapy in the pharmacological treatment of patients with first episode psychosis, regarding functionality of patients and positive and negative symptoms.
Secondary Objectives:
- To analyse certain biological parameters (BDNF and oxidative stress) in both arms (intervention and control) at baseline and during re-assessment (at six months and after completion of treatment).
- To analyse the effectiveness of online training of psychotherapists who will provide psychoeducation to patients with first episode psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual psychoeducation | Experimental | Other: Individual psychoeducationUsual treatment + individual psychoeducational intervention (14 sessions). The psychoeducational programme consists of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving. |
| Control | Active comparator | Other: ControlUsual treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who have suffered a first psychotic episode (diagnosis IV-TR) in the last five years,
- age between 18 and 45 years,
- patients who have given written informed consent to participate.
Key exclusion criteria (2 listed)
- patients with a comorbid disorder that interferes with their ability to communicate,
- patients who received psychoeducation previous to inclusion in study.
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 |
|---|---|---|
| ControlAlso: Usual treatmentUsual treatment: pharmacological treatment + regular sessions with their psychiatrist. | Other | Control |
| Individual psychoeducationUsual treatment + individual psychoeducational programme, consisting of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving. Programme of sessions available upon request. | Other | Individual psychoeducation |
Primary outcome
Prognosis of patients.
Time frame: 6 months
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.
4 secondary outcomes
Score on clinical scales assessing functionality.
Time frame: 6 months
Score of participating psychotherapists on a specific test after online training.
Time frame: 6 months
Biological Parameters: blood levels of BDNF.
Time frame: 6 months
Biological Parameters: levels oxidative stress indicators in blood.
Time frame: 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 26 Jan 2016.
- Derived from this study: PubMed 25348346Barbeito S, Vega P, Ruiz de Azua S, Balanza-Martinez V, Colom F, Lorente E, Luengo A, Cerrillo E, Crespo JM, Gonzalez Pinto A. Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial. Trials. 2014 Oct 27;15:416. doi: 10.1186/1745-6215-15-416.
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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.
Patricia Vega, Psychologist study chair
Santiago Hospital - Basque Health Service
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual psychoeducation in people with Psychosis, run by Basque Health Service at 6 sites 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 2 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 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Prognosis of patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783457, which also lists 1 linked publication.
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 26 Jan 2016.