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ARMSNCT01923701

Cognitive Behavioral Therapy for the Prevention of Paranoia in Adolescents at High Risk

A study testing Cognitive Behavioral Therapy in people with ARMS and APS, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to decrease the severity of symptoms and improve psycho-social functioning in youth at high risk of developing psychosis by providing a specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT). Read more about this study

Who is it for?
Ages 12 to 25 yearsHealthy volunteers can take part
Conditions the study is for
ARMS, APS, Prodromal Symptoms
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Oct 2012to Sep 2018
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 12 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • meets criteria for ARMS (at Risk Mental State, assessed by CAARMS)
  • Elevated suspiciousness (PANSS,P6≥3)

Who cannot join

  • A diagnosis of any of the following:
  • Moderate to severe learning disability
  • Substance dependence
  • Organic impairment known to affect brain

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medical College

    New York, New York, 10065

Other trials in United States

About this study

The main objective of this study is to decrease the severity of symptoms and improve psycho-social functioning in youth at high risk of developing psychosis by providing a specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT).

Read the detailed description

24 adolescents and young adults between the ages of 12 and 25 who are at high risk of developing psychosis and exhibit paranoid ideation will be recruited to participate in a pilot randomized controlled trial. Subjects will be randomly assigned to the intervention (GF-CBT)or control (symptom monitoring) groups. GF-CBT is based on a cognitive neuropsychiatric model of delusions, and incorporates recent developments in learning and cognitive theories. GF-CBT consists of individual, group, and family group sessions. The three-part program teaches adolescents and family members Cognitive Behavioral skills that they can continue using on their own after completion of the program. Preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and post-termination follow-up over the next 2 years. Hypotheses: (a) GF-CBT will be associated with: high rate of remission from "at risk status" and low rates of transition to psychosis (defined by CAARMS criteria); greater improvements in severity of symptoms; and improved functioning; (b) decrease in family members'level of stress, and improved coping; (c) Family members will demonstrate proficiency in CBT Skills.

Keywords
At Risk Mental State, Attenuated Psychosis Syndrome, Prodrom, Paranoia, Psychosis, Cognitive Behavioral Therapy, Group, Family, ARMS
Medical subject headings
Prodromal Symptoms, Paranoid Disorders, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    Also called Group and Family Based Cognitive Behavioral Therapy, GF-CBT

    GF-CBT focuses on teaching emotional self-regulation, information processing, decision making strategies,and logical thinking skills. The program is comprised of three parts: 1) Group sessions in which adolescents receive social support from peers who have had similar experiences and learn CBT skills, 2) Family group sessions in which family members learn more about adolescents' experiences and learn CBT skills so that they can encourage and reinforce these skills at home, and 3) Individual sessions in which adolescents can apply CBT skills to their own lives and work toward personal goals. Group sessions are taught with Powerpoint slides and with an accompanying workbook.

Study groups in NCT01923701
Study groupRoleWhat they receive
Cognitive Behavioral TherapyExperimentalCognitive Behavioral Therapy group receives group, individual, and family Cognitive Behavioral Therapy in addition to standard care.
Receives: Behavioral: Cognitive Behavioral Therapy
MonitoringNo interventionThis group receives standard care only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in CAARMS from Baseline

    Measured by the CAARMS-Comprehensive Assessment of At-Risk Mental State (Yung et al., 2005), a clinician-administered semi-structured interview. The CAARMS includes the following subscales: disorders of thought content, perceptual abnormalities, conceptual disorganization, disorganized speech, motor changes, concentration and attention, emotion and affect, subjectively impaired energy and impaired tolerance to normal stress, as well as a measure of functioning called the Social and Occupational Functioning Scale (SOFAS).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

Secondary outcomes (10)

  1. Change in Depressive Symptoms from Baseline

    The Beck Depression Inventory-2nd edition (BDI-II) is used to evaluate depressive symptoms (Beck, Steer, Ball,\& Ranieri, 1996).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  2. Change in Anxiety Symptoms from Baseline

    The State-Trait Anxiety Inventory (STAI) is used to measure state and trait anxiety(Speilberger, 1966; Speilberger, 1983).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  3. Change in PDI Score from Baseline

    Peters' Delusions Inventory (PDI), a 21-item self-report questionnaire and is used to measure delusional ideation across multiple dimensions including distress, preoccupation and conviction (E. Peters, Joseph, Day, \& Garety, 2004; E. R. Peters, Joseph, \& Garety, 1999).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  4. Change in Perceived Stress from Baseline

    The Perceived Stress Scale (PSS) is a 10-item self-report scale that measures the degree to which situations in one's life are appraised as stressful (Cohen, 1994).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  5. Change in Role and Social Functioning from Baseline

    The Global Functioning: Role (GFR) and Global Functioning: Social (GFS) scales are 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 age. Ratings are also based on demands of the role, level of independence or support provided to the individual and the individual's overall performance in the role given the level of support. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Age-appropriate social contacts and interactions outside of the family are considered, with an emphasis on social withdrawal and isolation (Cornblatt et al., 2007).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  6. Change in Social Functioning from Baseline

    The Social Functioning Scale (SFS) is administered both as a self-report measure to adolescents and as an observer-report to family members who evaluated adolescents' in seven areas: (a) social engagement/withdrawal (time spent alone, initiation of conversations, social avoidance), (b) interpersonal behavior (number of friends, quality of communication), (c) pro-social activities (engagement in a range of common social activities, e.g. sports), (d) recreation (engagement in a range of common hobbies and interests), (e) independence-competence (ability to perform skills necessary for independent living, (f) independence-performance (performance of skills necessary for independent living) and (g) employment/occupation (engagement in productive employment or structured daily activity (Birchwood, Smith, Cochrane, Wetton, \& Copestake, 1990).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  7. Change in Cognitive Biases from Baseline

    The Davos Assessment of Cognitive Biases (DACOBS) measures cognitive biases and safety behaviors. DACOBS includes 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 (Van der Gaag et al., 2013).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  8. Change from Baseline in a Tendency to Jump to Conclusions

    Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment(Dudley, John, Young, \& Over, 1997; P. A. Garety, Hemsley, \& Wessely, 1991; E. Peters \& Garety, 2006).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 17, and 29)

  9. Change in Family Member's Perceived Stress from Baseline

    The Perceived Stress Scale (PSS) is a 10-item self-report scale that measures the degree to which situations in one's life are appraised as stressful (Cohen, 1994).

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

  10. Change in Perceived Family Member Empathy from Baseline

    An adaptation of the Empathy Scale(Burns \& Auerbach, 1996) is used to measure adolescents' perception of their family member's warmth, genuineness, and empathy.

    Measured: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923701
Sponsor's protocol ID
1007011164
Other IDs
KL2 RR024496
Status last verified
Dec 2018
First submitted
24 Jul 2013
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

    PubMed 8991972

  • Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.

    PubMed 2289094

  • Cornblatt 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 17440198

  • Dudley RE, John CH, Young AW, Over DE. Normal and abnormal reasoning in people with delusions. Br J Clin Psychol. 1997 May;36(2):243-58. doi: 10.1111/j.2044-8260.1997.tb01410.x.

    PubMed 9167864

  • Garety PA, Hemsley DR, Wessely S. Reasoning in deluded schizophrenic and paranoid patients. Biases in performance on a probabilistic inference task. J Nerv Ment Dis. 1991 Apr;179(4):194-201. doi: 10.1097/00005053-199104000-00003.

    PubMed 2007889

  • Han DH, Park DB, Choi TY, Joo SY, Lee MK, Park BR, Nishimura R, Chu CC, Renshaw PF. Effects of brain-derived neurotrophic factor-catecholamine-O-methyltransferase gene interaction on schizophrenic symptoms. Neuroreport. 2008 Jul 16;19(11):1155-8. doi: 10.1097/WNR.0b013e32830867ad.

    PubMed 18596619

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PubMed 3616518

  • Landa Y; Chadwick P; Beck AT; Alexeenko L; Sheets M; Zhu Y; Silbersweig DA. (2011). Targeting information processing biases and social avoidance in group cognitive behavioral therapy for paranoia: A pilot randomized controlled clinical trial. Schizophr Bull; 37: 271-271.

  • Landa Y; Chadwick P; Stern E; Pan H; Alexeenko L; Zhu YH. . . . Silbersweig DA. Cognitive behavioral therapy for paranoia: A pilot randomized controlled clinical trial and fMRI investigation of systems-level brain circuit modulation. Biol Psychiatry 2012; 71(8): 65s-66s.

  • Landa Y; Silverstein S; Schwartz F; Savitz A. (2006). Group cognitive behavioral therapy for delusions: Helping patients improve reality testing. J Contemp Psychother; 36(1): 9-17. doi: 10.1007/s10879-005-9001-x

  • Loewy RL, Bearden CE, Johnson JK, Raine A, Cannon TD. The prodromal questionnaire (PQ): preliminary validation of a self-report screening measure for prodromal and psychotic syndromes. Schizophr Res. 2005 Sep 15;77(2-3):141-9. doi: 10.1016/j.schres.2005.03.007.

    PubMed 15905071

  • Peters E, Garety P. Cognitive functioning in delusions: a longitudinal analysis. Behav Res Ther. 2006 Apr;44(4):481-514. doi: 10.1016/j.brat.2005.03.008.

    PubMed 15913544

  • Peters E, Joseph S, Day S, Garety P. Measuring delusional ideation: the 21-item Peters et al. Delusions Inventory (PDI). Schizophr Bull. 2004;30(4):1005-22. doi: 10.1093/oxfordjournals.schbul.a007116.

    PubMed 15954204

  • Peters ER, Joseph SA, Garety PA. Measurement of delusional ideation in the normal population: introducing the PDI (Peters et al. Delusions Inventory). Schizophr Bull. 1999;25(3):553-76. doi: 10.1093/oxfordjournals.schbul.a033401.

    PubMed 10478789

  • Spitzer RL, Williams JB, Gibbon M, First MB. The Structured Clinical Interview for DSM-III-R (SCID). I: History, rationale, and description. Arch Gen Psychiatry. 1992 Aug;49(8):624-9. doi: 10.1001/archpsyc.1992.01820080032005.

    PubMed 1637252

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with ARMS and APS, run by Weill Medical College of Cornell University 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 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: finished, as of the sponsor's last update on 4 Dec 2018. 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?

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?

Change in CAARMS from Baseline (time frame: Assessed at baseline, Post-CBT (month 5), and at follow-up assessments (months 9, 13, 17, 21, 25 and 29)). 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 NCT01923701, which also lists 16 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 Dec 2018.

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