Clinical High Risk for PsychosisRobinNCT03829527
Evaluation of the Treatment Approach ROBIN
A study testing Psychotherapy in people with Clinical High Risk for Psychosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at Clinical High Risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 30 Sep 2022
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) At least two self-experienced and self-reported cognitive basic symptoms as assessed by the children-youth version of the Schizophrenia Proneness Interview Child and Youth Version (SPI-CY)
- and/or 2) at least one attenuated psychotic symptom for psychosis assessed by the Structured Interview for Prodromal Syndromes (SIPS)
Who cannot join
- a diagnosis of a psychotic disorder
- current substance or alcohol dependence
- insufficient German or English language ability
- low intellectual abilities with IQ <75
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy
Zurich, 8032
Maurizia Frascini, Dr.med., 41 43 499 26 26, Franscini Maurizia <Maurizia.Franscini@puk.zh.ch>
About this study
Official title: Evaluation of the Treatment Approach ROBIN (Standardized Manual and Smartphone App) for Adolescents With High Risk for Developing a Psychotic Disorder
The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at Clinical High Risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at CHR state and even first-episode psychosis is limited. To fill this gap, the clinicians from the early intervention center in Zurich have developed the treatment approach "Robin" (standardized manual and smartphone App) for adolescents with high risk for developing a psychotic disorder. The treatment approach is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. The evaluation aims firstly to compare the efficacy of "Robin" in 30 CHR adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. Primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy and quality of life. For the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with CHR for psychosis, aged 14-18, will be recruited over three years. At-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group.
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Psychological intervention combining a standardized treatment manual with a smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Not described Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in at risk symptoms over the different time points
According to a structured clinical interviews about the clinical high risk state(SIPS, SPI-CY)
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in comorbid symptoms over the different time points
According to a structured clinical interviews about the comorbid symptoms (M.I.N.I. Kid)
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in overall global functioning over the different time points
Measured by Global Assessment of Functioning Scale GAF. The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in the social and occupational functioning over the different time points
Measured by the Social and Occupational Functioning Assessment Scale SOFA . The SOFAS is a new scale that differs from the Global Assessment of Functioning (GAF) Scale in that it focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in social functioning over the different time points
Measured by theGlobal Functioning: Social (GF: Social) scale The GF: Social scale assesses quantity and quality of peer relationships, level of peer conflict, age-appropriate intimate relationships, and involvement with family members. Emphasis is placed on age-appropriate social contacts and interactions outside of the family, with a particular focus on social withdrawal and isolation. The scales range from 1 till 10 (10 is the highest rating).
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in the quality of life over the different time points: MANSA
Self reported level of life quality measured with the Manchester Short Assessment of Quality of Life (MANSA). 16 questions are to be asked every time the instrument is applied. Four of these questions are termed objective and to be answered with yes or no. Twelve questions are strictly subjective. The satisfaction is rated on 7-point rating scales ( = negative extreme, 7 = positive extreme). The twelve items are in the end combined (summed) to get a total score about the life quality.
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Changes in the self efficacy over the different time points: General Self-efficacy Scale (SWE)
Self reported level of self efficacy measured with the General Self-efficacy Scale (SWE). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. The total score can vary between 10 (very low self-efficacy) and 40 (very high self-efficacy).
Measured: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Secondary outcomes (2)
Satisfaction with the treatment: questionnaire
Subjective satisfaction with the therapy measured by a german questionnaire about the treatment satisfaction. The questionnaire is called "Fragebogens zur Beurteilung der Behandlung". Translation ins english is: Questionnaire about the treatment satisfaction.
It contains 20 different questions about the treatment satisfaction on a rating scale from 0 till 5. So, the total score is between 0 (no treatment satisfaction) and 100 (highest treatment satisfaction).
Measured: 4 months (post-treatment)
7.Satisfaction with the smartphone application Robin Z: feedback form.
Subjective satisfaction with the smartphone application measured by questionnaire regarding usability and subjective satisfaction with the app. The questionnaire was created by the study team, no standardized measurement tool is used. The questionnaire is a feedback form, that gives the study team qualitative information about the usability and satisfaction with the smartphone application. The only quantitive information that is gained from this questionnaire is the overall satisfaction with the application. The subjects can give a rating from 1 (lowest satisfaction) till 6 (highest satisfaction).
Measured: 4 months (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Sep 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829527
- Sponsor's protocol ID
- ETRo2017-00012
- Acronym
- Robin
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fux L, Walger P, Schimmelmann BG, Schultze-Lutter F. The Schizophrenia Proneness Instrument, Child and Youth version (SPI-CY): practicability and discriminative validity. Schizophr Res. 2013 May;146(1-3):69-78. doi: 10.1016/j.schres.2013.02.014. Epub 2013 Mar 6.
PubMed 23473813Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
PubMed 14989408Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538Hall RC. Global assessment of functioning. A modified scale. Psychosomatics. 1995 May-Jun;36(3):267-75. doi: 10.1016/S0033-3182(95)71666-8.
PubMed 7638314Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17.
PubMed 17440198Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.
PubMed 10782554Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.
PubMed 10443245Schwarzer, R., & Jerusalem, M. (1995). General Self-efficacy Scale. Measures in Health Psychology: A User's Portfolio. Causal and Control Beliefs, (2008), 35-37.
Traber-Walker N, Gerstenberg M, Metzler S, Joris MR, Karr M, Studer N, Zulauf Logoz M, Roth A, Rossler W, Walitza S, Franscini M. Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis. Front Psychiatry. 2019 Jun 6;10:384. doi: 10.3389/fpsyt.2019.00384. eCollection 2019.
PubMed 31244692
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Approach ROBIN (Standardized Manual and Smartphone App) for Adolescents With High Risk for Developing a Psychotic Disorder
- ClinicalTrials.gov ID
- NCT03829527
- Acronym / sponsor ID
- Robin / ETRo2017-00012
- Conditions
- Clinical High Risk for Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 4 Feb 2019 (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.
The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at Clinical High Risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at CHR state and even first-episode psychosis is limited. To fill this gap, the clinicians from the early intervention center in Zurich have developed the treatment approach "Robin" (standardized manual and smartphone App) for adolescents with high risk for developing a psychotic disorder. The treatment approach is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. The evaluation aims firstly to compare the efficacy of "Robin" in 30 CHR adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. Primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy and quality of life. For the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with CHR for psychosis, aged 14-18, will be recruited over three years. At-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group.
Study design
- Primary purpose
- Prevention
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Psychotherapy |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1) At least two self-experienced and self-reported cognitive basic symptoms as assessed by the children-youth version of the Schizophrenia Proneness Interview Child and Youth Version (SPI-CY)
- and/or 2) at least one attenuated psychotic symptom for psychosis assessed by the Structured Interview for Prodromal Syndromes (SIPS)
Key exclusion criteria (4 listed)
- a diagnosis of a psychotic disorder
- current substance or alcohol dependence
- insufficient German or English language ability
- low intellectual abilities with IQ <75
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 |
|---|---|---|
| PsychotherapyPsychological intervention combining a standardized treatment manual with a smartphone application | Behavioural | Psychotherapy |
Primary outcome
Changes in at risk symptoms over the different time points
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
According to a structured clinical interviews about the clinical high risk state(SIPS, SPI-CY)
Changes in comorbid symptoms over the different time points
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
According to a structured clinical interviews about the comorbid symptoms (M.I.N.I. Kid)
Changes in overall global functioning over the different time points
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by Global Assessment of Functioning Scale GAF. The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Changes in the social and occupational functioning over the different time points
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by the Social and Occupational Functioning Assessment Scale SOFA . The SOFAS is a new scale that differs from the Global Assessment of Functioning (GAF) Scale in that it focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Changes in social functioning over the different time points
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by theGlobal Functioning: Social (GF: Social) scale The GF: Social scale assesses quantity and quality of peer relationships, level of peer conflict, age-appropriate intimate relationships, and involvement with family members. Emphasis is placed on age-appropriate social contacts and interactions outside of the family, with a particular focus on social withdrawal and isolation. The scales range from 1 till 10 (10 is the highest rating).
Changes in the quality of life over the different time points: MANSA
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Self reported level of life quality measured with the Manchester Short Assessment of Quality of Life (MANSA). 16 questions are to be asked every time the instrument is applied. Four of these questions are termed objective and to be answered with yes or no. Twelve questions are strictly subjective. The satisfaction is rated on 7-point rating scales ( = negative extreme, 7 = positive extreme). The twelve items are in the end combined (summed) to get a total score about the life quality.
Changes in the self efficacy over the different time points: General Self-efficacy Scale (SWE)
Time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Self reported level of self efficacy measured with the General Self-efficacy Scale (SWE). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. The total score can vary between 10 (very low self-efficacy) and 40 (very high self-efficacy).
2 secondary outcomes
Satisfaction with the treatment: questionnaire
Time frame: 4 months (post-treatment)
7.Satisfaction with the smartphone application Robin Z: feedback form.
Time frame: 4 months (post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 23473813Fux L, Walger P, Schimmelmann BG, Schultze-Lutter F. The Schizophrenia Proneness Instrument, Child and Youth version (SPI-CY): practicability and discriminative validity. Schizophr Res. 2013 May;146(1-3):69-78. doi: 10.1016/j.schres.2013.02.014. Epub 2013 Mar 6.
- Background: PubMed 14989408Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040.
- Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Background: PubMed 7638314Hall RC. Global assessment of functioning. A modified scale. Psychosomatics. 1995 May-Jun;36(3):267-75. doi: 10.1016/S0033-3182(95)71666-8.
- Background: PubMed 17440198Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17.
- Background: PubMed 10782554Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.
- Background: PubMed 10443245Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.
- BackgroundSchwarzer, R., & Jerusalem, M. (1995). General Self-efficacy Scale. Measures in Health Psychology: A User's Portfolio. Causal and Control Beliefs, (2008), 35-37.
- Derived from this study: PubMed 31244692Traber-Walker N, Gerstenberg M, Metzler S, Joris MR, Karr M, Studer N, Zulauf Logoz M, Roth A, Rossler W, Walitza S, Franscini M. Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis. Front Psychiatry. 2019 Jun 6;10:384. doi: 10.3389/fpsyt.2019.00384. eCollection 2019.
- 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.
University of Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Clinical High Risk for Psychosis, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 4 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 4 Feb 2019. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in at risk symptoms over the different time points (time frame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)). The study lists 7 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 NCT03829527, which also lists 9 linked publications.
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 4 Feb 2019.