Young Subjects With at Risk Mental StatesSTARTNCT02368353
"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"
A study testing Cognitive behavioral therapy and Supportive therapy in people with Young Subjects With at Risk Mental States, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Young Subjects With at Risk Mental States
- What is being tested?
- Cognitive behavioral therapy and Supportive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2015to Aug 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 15 to 25 years
- Help-seekers in one of the specialized clinics for adolescents or young adults 9
- Meets CAARMS criteria for 'at risk mental state' (ARMS)
Who cannot join
- situations of emergency.
- prengnancy, breast-feeding
- Forced hospitalization or individuals under legal guardianship.
- schizophrenia (DSMIV-TR criteria)
- Low IQ (<70) ,
- Mother tongue and primary educational language other than French
Show all 18Show fewer
- Blindness, deafness, muteness, sensorimotor or language deficits
- any severe medical condition,
- Daily cannabis use in the last week
- Current depression (>20 MADRS scale)
- Substance dependence or abuse (except nicotine) for more than 5 years.
- Treatments by benzodiazépine (> 10 mg amount diazépam) or stop of less than 5 days
- Previous treatment by antipsychotics in a superior dose in more than 100 mg equivalent Chlorpromazine if at least a sequence lasted more than 12 weeks
- Treatment by antipsychotics measures > 100 mg eq. CPZactuel (superior dose in more than 100 mg equivalent Chlorpromazine) so introduced for less than three weeks
- Antidepressant treatmentsbegun for less three weeks
- Treatment by corticoids (except local treatment)
- The usual contraindications for MRI
- Absence of social insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sainte Anne
Paris, 75014
Marie-Odile KREBS, MD, PhD, 00331 45 65 86 46, mo.krebs@ch-sainte-anne.fr
Marie GODARD, 0033145657728, m.godard@ch-sainte-anne.fr
About this study
Official title: Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial
The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. The clinical criteria "mental status with risk" (AR) identifies patients among whom 10 in 40 % will make a psychotic transition in the year.
Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our project is to evaluate a therapy for stress management in at risk patients, compared to a conventional monitoring, and implement a longitudinal follow-up concerning the reduction of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these interventions offer an alternative to antipsychotics all the more interesting since they should also reduce the risk of depression and suicide.
- Being tested
- Cognitive behavioral therapy, Supportive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | weekly group stress-management CBT (SM-CBT) - 1/week 3 months Receives: Other: Cognitive behavioral therapy |
| Reference group | Active comparator | weekly supportive therapy - 1/week 3 months Receives: Other: Supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).
Measured: Month 6
Secondary outcomes (35)
Score on CAARMS
Measured: Month 0
Score on CAARMS
Measured: Month 6
Score on CAARMS
Measured: Month 12
· Rate of conversion (as defined by CAARMS)
Measured: Month 6
· Rate of conversion (as defined by CAARMS)
Measured: Month 12
Score on BPRS
Measured: Month 0
Score on BPRS
Measured: Month 6
Score on BPRS
Measured: Month 12
Score on MADRS
Measured: Month 0
Score on MADRS
Measured: Month 6
Score on MADRS
Measured: Month 12
Score on YMRS
Measured: Month 0
Score on YMRS
Measured: Month 6
Score on YMRS
Measured: Month 12
Score on SOFAS
Measured: Month 0
Score on SOFAS
Measured: Month 6
Score on SOFAS
Measured: Month 12
Stress marker : saliva cortisol level
Measured: Month 0
Stress marker : saliva cortisol level
Measured: Month 6
Stress marker : saliva cortisol level
Measured: Month 12
Stress marker : telomerase activity
Measured: Month 0
Stress marker : telomerase activity
Measured: Month 6
Stress marker : telomerase activity
Measured: Month 12
Stress marker : epigenetic markers
Measured: Month 0
Stress marker : epigenetic markers
Measured: Month 6
Stress marker : epigenetic markers
Measured: Month 12
Stress marker : genetic variants that modulate stress response
Measured: Month 0
Stress marker : genetic variants that modulate stress response
Measured: Month 6
Stress marker : genetic variants that modulate stress response
Measured: Month 12
Stress marker : hippocampal volume
Measured: Month 0
Stress marker : hippocampal volume
Measured: Month 12
Performance score on autobiographic memory
Measured: Month 0
Performance score on autobiographic memory
Measured: Month 12
Performance score on sense of self tasks
Measured: Month 0
Performance score on sense of self tasks
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start13 Feb 2015
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young Subjects With at Risk Mental StatesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368353
- Sponsor's protocol ID
- D14-P008
- Acronym
- START
- Status last verified
- Oct 2017
- First submitted
- 6 Feb 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02368353
- Acronym / sponsor ID
- START / D14-P008
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 13 Feb 2015 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 23 Feb 2015 (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.
The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. The clinical criteria "mental status with risk" (AR) identifies patients among whom 10 in 40 % will make a psychotic transition in the year.
Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our project is to evaluate a therapy for stress management in at risk patients, compared to a conventional monitoring, and implement a longitudinal follow-up concerning the reduction of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these interventions offer an alternative to antipsychotics all the more interesting since they should also reduce the risk of depression and suicide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | Other: Cognitive behavioral therapyweekly group stress-management CBT (SM-CBT) - 1/week 3 months |
| Reference group | Active comparator | Other: Supportive therapyweekly supportive therapy - 1/week 3 months |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 15 to 25 years
- Help-seekers in one of the specialized clinics for adolescents or young adults 9
- Meets CAARMS criteria for 'at risk mental state' (ARMS)
Key exclusion criteria (18 listed)
- situations of emergency.
- prengnancy, breast-feeding
- Forced hospitalization or individuals under legal guardianship.
- schizophrenia (DSMIV-TR criteria)
- Low IQ (<70) ,
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 | Other | Cognitive behavioral therapy group |
| Supportive therapy | Other | Reference group |
Primary outcome
The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).
Time frame: Month 6
35 secondary outcomes
Score on CAARMS
Time frame: Month 0
Score on CAARMS
Time frame: Month 6
Score on CAARMS
Time frame: Month 12
· Rate of conversion (as defined by CAARMS)
Time frame: Month 6
· Rate of conversion (as defined by CAARMS)
Time frame: Month 12
Score on BPRS
Time frame: Month 0
Score on BPRS
Time frame: Month 6
Score on BPRS
Time frame: Month 12
Score on MADRS
Time frame: Month 0
Score on MADRS
Time frame: Month 6
Score on MADRS
Time frame: Month 12
Score on YMRS
Time frame: Month 0
Score on YMRS
Time frame: Month 6
Score on YMRS
Time frame: Month 12
Score on SOFAS
Time frame: Month 0
Score on SOFAS
Time frame: Month 6
Score on SOFAS
Time frame: Month 12
Stress marker : saliva cortisol level
Time frame: Month 0
Stress marker : saliva cortisol level
Time frame: Month 6
Stress marker : saliva cortisol level
Time frame: Month 12
Stress marker : telomerase activity
Time frame: Month 0
Stress marker : telomerase activity
Time frame: Month 6
Stress marker : telomerase activity
Time frame: Month 12
Stress marker : epigenetic markers
Time frame: Month 0
Stress marker : epigenetic markers
Time frame: Month 6
Stress marker : epigenetic markers
Time frame: Month 12
Stress marker : genetic variants that modulate stress response
Time frame: Month 0
Stress marker : genetic variants that modulate stress response
Time frame: Month 6
Stress marker : genetic variants that modulate stress response
Time frame: Month 12
Stress marker : hippocampal volume
Time frame: Month 0
Stress marker : hippocampal volume
Time frame: Month 12
Performance score on autobiographic memory
Time frame: Month 0
Performance score on autobiographic memory
Time frame: Month 12
Performance score on sense of self tasks
Time frame: Month 0
Performance score on sense of self tasks
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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.
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 and Supportive therapy in people with Young Subjects With at Risk Mental States, run by Centre Hospitalier St Anne at 1 site in France.
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 18 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 20 Oct 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Odile KREBS KREBS, MD, PhD (0033145658646, mo.krebs@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts). (time frame: Month 6). 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 20 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.