First-episode PsychosisNCT02319746
COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
A study testing Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse and Psychoeducation in people with First-episode Psychosis and Cannabis Abuse, run by Basque Health Service at 1 site in Spain.
Trial summary
General objective: To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- First-episode Psychosis, Cannabis Abuse
- What is being tested?
- Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Sep 2019
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms).
- - Being a regular cannabis user according DSM-IV
- -Being in remission from the first psychotic episode (not exceeding 5 years).
Who cannot join
- Presenting organic brain pathology.
- Presenting mental retardation according to DSM-IV criteria.
Trial locations and contacts
1 site in 1 country.
About this study
General objective:
To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.
Read more
Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.
Patients will be randomly assigned to one of two treatments:
- Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
- Control group (N=50): standard treatment: psychoeducation + pharmacological treatment
- Conditions
- First-episode Psychosis, Cannabis Abuse
- Being tested
- Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse, Psychoeducation
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuseBehavioural
The intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention.
PsychoeducationBehavioural
The aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The subjects of experimental group will receive a cognitive-behavioral treatment program specific for reduce cannabis use composed of 16 weekly sessions (one hour in duration), in addition to regular psychiatric review and pharmacological treatment. The group will consist of 6-8 subjects. Receives: Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse |
| Control group | Active comparator | The control group will receive standard care for psychotic episodes which includes pharmacological treatment and psychoeducation, following the same format as the experimental group. 16 weekly sessions of psychoeducation (one hour in duration) will be conducted, in addition to regular psychiatric review and pharmacological treatment. Like the experimental group the group will consist of 6-8 subjects. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis use reduction in the follow-up
To assess whether cannabis focused psychological intervention is associated with a cannabis use reduction according to Europ-ASI scale compared to standard treatment
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
Improvement in the development of psychotic disorder
To assess whether cannabis focused psychological intervention is associated with an improvement in the development of psychotic disorder (ie, reduction of symptoms and improvement of psychosocial functioning) compared with standard treatment at the end of treatment and at follow-up (at three and six months and one year of follow-up).
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Changes in the components of the endogenous cannabinoid system
To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Normalizing the possible alterations in the endogenous cannabinoid system
To assess whether treatment program specific for cannabis abstinence is capable of normalizing the possible alterations in the endogenous cannabinoid system in patients that reduce the cannabis use.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary outcomes (7)
Decrease the number of cannabis users
To determinate the number of patient who use cannabis in the follow-up in each group
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of negative and positive psychotic symptoms
To compare the decrease of negative and positive psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS), at post-treatment and follow-up.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of manic, depressive and anxiety symptoms
To compare the decrease of manic, depressive and anxiety symptoms at post-treatment and follow-up. Manic symptoms will be measured using Young Mania Rating Scale (YMRS). Anxiety and depressive symptoms will be measured using Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D), respectively.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the psychosocial functioning
To compare the improvement of psychosocial functioning in each group by Functioning Assessment Short Test (FAST).
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the adherence to pharmacological treatment
To compare the adherence to pharmacological treatment in each group using Morisky-Green Scale.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Withdrawal of patients
To evaluate percentage of withdrawal in the follow-up.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease the number of relapses and rehospitalizations
To compare the number of relapses and rehospitalizations in in each group.
Measured: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2018
- Study completionSep 2019
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 First-episode 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Itxaso Ortega Gonzalez, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319746
- Sponsor's protocol ID
- COG-CON
- Status last verified
- Jan 2020
- First submitted
- 10 Dec 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzalez-Ortega I, Echeburua E, Garcia-Alocen A, Vega P, Gonzalez-Pinto A. Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:372. doi: 10.1186/s13063-016-1507-x.
PubMed 27473688
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE
- ClinicalTrials.gov ID
- NCT02319746
- Acronym / sponsor ID
- COG-CON
- Conditions
- First-episode Psychosis, Cannabis Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Dec 2014 (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.
General objective:
To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.
Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.
Patients will be randomly assigned to one of two treatments:
- Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
- Control group (N=50): standard treatment: psychoeducation + pharmacological treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuseThe subjects of experimental group will receive a cognitive-behavioral treatment program specific for reduce cannabis use composed of 16 weekly sessions (one hour in duration), in addition to regular psychiatric review and pharmacological treatment. The group will consist of 6-8 subjects. |
| Control group | Active comparator | Behavioral: PsychoeducationThe control group will receive standard care for psychotic episodes which includes pharmacological treatment and psychoeducation, following the same format as the experimental group. 16 weekly sessions of psychoeducation (one hour in duration) will be conducted, in addition to regular psychiatric review and pharmacological treatment. Like the experimental group the group will consist of 6-8 subjects. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- - Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms).
- - Being a regular cannabis user according DSM-IV
- -Being in remission from the first psychotic episode (not exceeding 5 years).
Key exclusion criteria (2 listed)
- Presenting organic brain pathology.
- Presenting mental retardation according to DSM-IV criteria.
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 |
|---|---|---|
| Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuseThe intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention. | Behavioural | Experimental group |
| PsychoeducationThe aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing. | Behavioural | Control group |
Primary outcome
Cannabis use reduction in the follow-up
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
To assess whether cannabis focused psychological intervention is associated with a cannabis use reduction according to Europ-ASI scale compared to standard treatment
Improvement in the development of psychotic disorder
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether cannabis focused psychological intervention is associated with an improvement in the development of psychotic disorder (ie, reduction of symptoms and improvement of psychosocial functioning) compared with standard treatment at the end of treatment and at follow-up (at three and six months and one year of follow-up).
Changes in the components of the endogenous cannabinoid system
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers.
Normalizing the possible alterations in the endogenous cannabinoid system
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
To assess whether treatment program specific for cannabis abstinence is capable of normalizing the possible alterations in the endogenous cannabinoid system in patients that reduce the cannabis use.
7 secondary outcomes
Decrease the number of cannabis users
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of negative and positive psychotic symptoms
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease of manic, depressive and anxiety symptoms
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the psychosocial functioning
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Improvement in the adherence to pharmacological treatment
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Withdrawal of patients
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Decrease the number of relapses and rehospitalizations
Time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
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 18 Jan 2020.
- Derived from this study: PubMed 27473688Gonzalez-Ortega I, Echeburua E, Garcia-Alocen A, Vega P, Gonzalez-Pinto A. Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:372. doi: 10.1186/s13063-016-1507-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse and Psychoeducation in people with First-episode Psychosis and Cannabis Abuse, run by Basque Health Service 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 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 18 Jan 2020. 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?
Cannabis use reduction in the follow-up (time frame: Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.). The study lists 4 primary outcomes in all. 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 NCT02319746, 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 18 Jan 2020.