Clinical High Risk for Psychosis (CHR)NCT05968560
Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis
A study testing CBT Skills Group for CHR Youth, Individual CBT sessions and CBT Skills Group for Families in people with Clinical High Risk for Psychosis (CHR), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- CBT Skills Group for CHR Youth, Individual CBT sessions and CBT Skills Group for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-25
- Ability to participate in assessments and treatment in English
- Meets criteria for psychosis-risk on SIPS
- Stable on medications; no changes within 1 month prior to enrollment
- Identification of one "family member" with >4 hours/week contact who is willing to participate ("Family member" can be any blood relative, spouse, significant other, or close friend whom the subject identifies as a consistent and important person in their life).
Who cannot join
- Intellectual disability (IQ<70)
- Medical condition known to cause psychosis
- Moderate or severe substance use disorder and active use within the past 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Yulia Landa, PsyD,MS, 212-585-4658, yulia.landa@mssm.edu
Rachel Jespersen, LMSW, 212-585-4641, rachel.jespersen@mssm.edu
About this study
Official title: Telehealth Adaptation of Group and Family-Based Cognitive Behavioral Therapy for Youth at Risk for Psychosis
This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.
Read the detailed description
Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in social and cognitive development, and can therefore have a profoundly adverse impact on an individual's long-term functioning. The onset of psychosis is preceded by a clinical high risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR programs have enormous potential to reduce the long-term severity of the illness, and the suffering and cost associated with it. Youth at CHR also typically have environmental and individual-level barriers to accessing and engaging in services, including stigma, a dearth of trained providers, clinic location and transportation issues, suspiciousness, and a tendency to socially isolate. Reducing some of these barriers via telehealth interventions may improve treatment accessibility and engagement, thereby improving clinical outcomes. There is a substantial need to evaluate different CHR interventions to determine which are most effective. There is also a significant need to systematically investigate remote delivery methods as a way of increasing access to critical services for CHR. The research team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory, psychosocial resilience models, and research on information processing in delusions. GF-CBT has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth and families learn CBT skills as a family unit, rather than in groups. The research team have adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and I-CBT-TH). This study will investigate the feasibility of implementing these telehealth interventions in the context of routine CHR services, evaluate the impact of the interventions on engaging target mechanisms hypothesized to underlie their effects, and conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of 14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by recruitment rate, attendance, and retention. The following intervention targets will be assessed: cognitive biases, social connectedness, family emotional climate, and family members' proficiency in CBT skills. The three groups will be compared across the following domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. The research team will also explore whether patient treatment preference, family emotional climate and sociodemographic factors differentially moderate treatment outcomes. Qualitative interviews will be conducted with patients, families, and clinicians to inform dissemination and make adaptations to the implementation manuals.
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- CBT Skills Group for CHR Youth, Individual CBT sessions, CBT Skills Group for Families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT Skills Group for CHR YouthBehavioural
CBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses "CBT to Prevent Paranoia" manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening.
Individual CBT sessionsBehavioural
CBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed.
CBT Skills Group for FamiliesBehavioural
Family members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in "CBT Skills for Families" manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week.
| Study group | Role | What they receive |
|---|---|---|
| Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH) | Experimental | GF-CBT via telehealth is an intervention consisting of three parts: 15 group sessions for young people, 15 individual sessions for young people, and 15 group sessions for families. The group sessions for young people and families focus on teaching CBT skills. The goal is to enhance reasoning, decision-making, and positive beliefs while reducing cognitive biases, distress, and isolation. The individual sessions personalize the CBT skills learned in the group, focusing on tailoring skills to personal goals. Family members also participate in group sessions to learn the same CBT skills and how to prompt and support their young family members in using these skills. All sessions are conducted via Telehealth Receives: Behavioral: CBT Skills Group for CHR Youth; Behavioral: Individual CBT sessions; Behavioral: CBT Skills Group for Families |
| Family-Based Cognitive Behavioral Therapy (F-CBT-TH) | Experimental | F-CBT via telehealth consists of two parts: 15 family sessions and 15 individual sessions for young people. The family sessions focus on teaching CBT skills to a family units. The individual sessions with youth personalize the CBT skills learned in the family sessions, focusing on tailoring skills to personal goals. All sessions are conducted via Telehealth. Receives: Behavioral: Individual CBT sessions; Behavioral: CBT Skills Group for Families |
| Individual Cognitive Behavioral Therapy (I-CBT-TH) | Active comparator | I-CBT-TH via telehealth consists of two components: 15 CBT Skill Learning sessions and 15 follow-up session that personalizes the learned skills. All sessions are conducted via Telehealth. Receives: Behavioral: Individual CBT sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Global Functioning: Role (GFR) Scale
The Global Functioning: Role (GFR) scale, clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on their primary role. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Ratings on a 10-point scale (1= Extreme Role Dysfunction to 10 = Superior Role Functioning) with higher scores representing better role functioning.
Measured: Up to week 28
Global Functioning: Social (GFS) Scale
The Global Functioning: Social (GFS) scales, clinician administered scales, derived from the GAF format. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. The GFS scale scores range from 1 to 10 with higher scores representing better social functioning.
Measured: Up to week 28
Secondary outcomes (6)
The Structured Interview for Psychosis Risk Syndromes (SIPS)
Symptom severity will be measured by SIPS, which consists of five positive-symptoms subscales (Unusual thought content/ delusional ideas, Suspiciousness/persecutory ideas, Grandiosity, Perceptual abnormalities/hallucinations, and Disorganized communication), as well as subscales for negative, disorganization, and general symptoms. SIPS will also be used to compare the three arms on rates of remission from CHR and number of transitions to psychosis. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score represents more favorable outcomes.
Measured: Up to week 28
Peters' Delusions Inventory (PDI)
The Peters' Delusions Inventory (PDI), a self-report scale measuring the presence of 21 common delusional thoughts and the distress, preoccupation, and conviction associated with each belief. The Peters Delusional Inventory (PDI) assesses the presence and severity of delusional beliefs. It is used to measure the intensity and conviction of delusions in individuals experiencing psychosis or related conditions. The PDI consists of a series of statements that the respondent rates based on their agreement or disagreement. The PDI includes a total of 21 items, and each item is rated on a 5-point Likert scale ranging from 1 to 5. There are 3 subscales: Distress, preoccupation and conviction. Higher scores on the PDI indicate a greater intensity and conviction of delusional beliefs. The scale ranges from 0 to 336, with 0 indicating no endorsement of delusion.
Measured: Up to week 28
Davos Assessment of Cognitive Biases
Cognitive biases will be assessed using the Davos Assessment of Cognitive Biases, a self-report scale that measures cognitive biases across the following sub-scales: Jumping to Conclusions Bias, Belief Inflexibility Bias, Attention for Threat Bias, External Attribution Bias, Social Cognition Problems, Subjective Cognitive Problems, and Safety Behaviors. The scale ranges from 42 to 294, with higher scores indicating higher cognitive biases .
Measured: Up to week 28
Social Connectedness Scale Revised
Social connectedness will be assessed using the Social Connectedness Scale Revised, a 20-item self-report scale that measures the degree to which one feels connected to their social environment. The scale ranges from 20 to 120, with higher scores indicating greater social connectedness.
Measured: Up to week 28
Family Attitudes Scale (FAS)
The Family Attitudes Scale (FAS) is a 30-item scale that can be completed by any informant to measure the family emotional climate. Participating family members will complete the Family Attitudes Scale. The scale ranges from 0 to 120, with higher scores indicating more negative attitudes.
Measured: Up to week 28
Angry Behaviors Scale (ABS)
Youth will complete the Angry Behaviors Scale (ABS), which is comprised of four items from the FAS. The scale ranges from 0 to 16, with higher scores indicating greater expression of anger.
Measured: Up to week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start21 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Yulia Landa, Icahn School of Medicine at Mount Sinai
- Investigators
- Yulia Landa, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968560
- Sponsor's protocol ID
- GCO 21-0328
- Other IDs
- R34MH128502
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.
PubMed 25585830
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Adaptation of Group and Family-Based Cognitive Behavioral Therapy for Youth at Risk for Psychosis
- ClinicalTrials.gov ID
- NCT05968560
- Acronym / sponsor ID
- GCO 21-0328
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.
Detailed description
Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in social and cognitive development, and can therefore have a profoundly adverse impact on an individual's long-term functioning. The onset of psychosis is preceded by a clinical high risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR programs have enormous potential to reduce the long-term severity of the illness, and the suffering and cost associated with it. Youth at CHR also typically have environmental and individual-level barriers to accessing and engaging in services, including stigma, a dearth of trained providers, clinic location and transportation issues, suspiciousness, and a tendency to socially isolate. Reducing some of these barriers via telehealth interventions may improve treatment accessibility and engagement, thereby improving clinical outcomes. There is a substantial need to evaluate different CHR interventions to determine which are most effective. There is also a significant need to systematically investigate remote delivery methods as a way of increasing access to critical services for CHR. The research team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory, psychosocial resilience models, and research on information processing in delusions. GF-CBT has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth and families learn CBT skills as a family unit, rather than in groups. The research team have adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and I-CBT-TH). This study will investigate the feasibility of implementing these telehealth interventions in the context of routine CHR services, evaluate the impact of the interventions on engaging target mechanisms hypothesized to underlie their effects, and conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of 14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by recruitment rate, attendance, and retention. The following intervention targets will be assessed: cognitive biases, social connectedness, family emotional climate, and family members' proficiency in CBT skills. The three groups will be compared across the following domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. The research team will also explore whether patient treatment preference, family emotional climate and sociodemographic factors differentially moderate treatment outcomes. Qualitative interviews will be conducted with patients, families, and clinicians to inform dissemination and make adaptations to the implementation manuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH) | Experimental | Behavioral: CBT Skills Group for CHR Youth, Behavioral: Individual CBT sessions, Behavioral: CBT Skills Group for FamiliesGF-CBT via telehealth is an intervention consisting of three parts: 15 group sessions for young people, 15 individual sessions for young people, and 15 group sessions for families. The group sessions for young people and families focus on teaching CBT skills. The goal is to enhance reasoning, decision-making, and positive beliefs while reducing cognitive biases, distress, and isolation. The individual sessions personalize the CBT skills learned in the group, focusing on tailoring skills to personal goals. Family members also participate in group sessions to learn the same CBT skills and how to prompt and support their young family members in using these skills. All sessions are conducted via Telehealth |
| Family-Based Cognitive Behavioral Therapy (F-CBT-TH) | Experimental | Behavioral: Individual CBT sessions, Behavioral: CBT Skills Group for FamiliesF-CBT via telehealth consists of two parts: 15 family sessions and 15 individual sessions for young people. The family sessions focus on teaching CBT skills to a family units. The individual sessions with youth personalize the CBT skills learned in the family sessions, focusing on tailoring skills to personal goals. All sessions are conducted via Telehealth. |
| Individual Cognitive Behavioral Therapy (I-CBT-TH) | Active comparator | Behavioral: Individual CBT sessionsI-CBT-TH via telehealth consists of two components: 15 CBT Skill Learning sessions and 15 follow-up session that personalizes the learned skills. All sessions are conducted via Telehealth. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 14-25
- Ability to participate in assessments and treatment in English
- Meets criteria for psychosis-risk on SIPS
- Stable on medications; no changes within 1 month prior to enrollment
- Identification of one "family member" with >4 hours/week contact who is willing to participate ("Family member" can be any blood relative, spouse, significant other, or close friend whom the subject identifies as a consistent and important person in their life).
Key exclusion criteria (3 listed)
- Intellectual disability (IQ<70)
- Medical condition known to cause psychosis
- Moderate or severe substance use disorder and active use within the past 30 days.
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 |
|---|---|---|
| CBT Skills Group for CHR YouthCBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses "CBT to Prevent Paranoia" manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening. | Behavioural | Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH) |
| Individual CBT sessionsCBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed. | Behavioural | Family-Based Cognitive Behavioral Therapy (F-CBT-TH), Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH), Individual Cognitive Behavioral Therapy (I-CBT-TH) |
| CBT Skills Group for FamiliesFamily members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in "CBT Skills for Families" manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week. | Behavioural | Family-Based Cognitive Behavioral Therapy (F-CBT-TH), Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH) |
Primary outcome
The Global Functioning: Role (GFR) Scale
Time frame: Up to week 28
The Global Functioning: Role (GFR) scale, clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on their primary role. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Ratings on a 10-point scale (1= Extreme Role Dysfunction to 10 = Superior Role Functioning) with higher scores representing better role functioning.
Global Functioning: Social (GFS) Scale
Time frame: Up to week 28
The Global Functioning: Social (GFS) scales, clinician administered scales, derived from the GAF format. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. The GFS scale scores range from 1 to 10 with higher scores representing better social functioning.
6 secondary outcomes
The Structured Interview for Psychosis Risk Syndromes (SIPS)
Time frame: Up to week 28
Peters' Delusions Inventory (PDI)
Time frame: Up to week 28
Davos Assessment of Cognitive Biases
Time frame: Up to week 28
Social Connectedness Scale Revised
Time frame: Up to week 28
Family Attitudes Scale (FAS)
Time frame: Up to week 28
Angry Behaviors Scale (ABS)
Time frame: Up to week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 25585830Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Yulia Landa principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT Skills Group for CHR Youth, Individual CBT sessions and CBT Skills Group for Families in people with Clinical High Risk for Psychosis (CHR), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yulia Landa, PsyD, MS (212-585-4658, yulia.landa@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Global Functioning: Role (GFR) Scale (time frame: Up to week 28). The study lists 2 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 NCT05968560, 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 20 Jan 2026.