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Boston, Massachusetts 02115


Purpose:

The purpose of this study is to test the feasibility of a modification of CET (Cognitive Enhancement Therapy) to address symptomatic and functional difficulties associated with Clinical High Risk for Psychosis (CHR). Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to improve school, work, and social functioning. CLUES includes the following: 1. Computerized cognitive remediation ("exercises") to improve cognition. 2. Social-cognitive skills group designed to teach participants to act wisely in social situations. 3. Individual coaching sessions designed to enhance translation of skills learned from computer exercises and the group into real life. CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was designed for treating individuals with schizophrenia. Research on CET for individuals with schizophrenia has found that CET appears to have helped participants improve cognition and social and work functioning. This study will investigate the feasibility of CLUES for young people who are showing signs of clinical risk for psychosis. Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of target engagement (change in cognition and social cognition), to refine assessment and recruitment approaches, to further optimize the treatment manual, and to ascertain feasibility and tolerability. Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) + computer games to explore preliminary evidence of efficacy of CLUES vs. the control treatment (n=30).


Study summary:

Psychotic disorders such as schizophrenia (SZ) are among the most disabling conditions in all of medicine. These disorders typically begin in adolescence or young adulthood, and are preceded by premorbid impairments in cognitive and social function dating from early childhood; these deficits worsen in adolescence and are accompanied by sub-threshold positive and negative symptoms (the prodromal, or clinical high risk state, CHR) before onset of the first psychotic episode. Recent staging models have operationalized approaches to defining early and late phases of CHR; Early CHR (stage 1a) is characterized by cognitive impairments and sub-threshold negative symptoms, while late CHR (stage 1b) is associated with sub-threshold positive and disorganized symptoms as well as further cognitive and functional declines. The emergence of cognitive and functional decline in Individuals at CHR who convert to psychosis highlights the importance of early intervention. Impairments in cognition are present in children who later go on to develop SZ. Impairments in cognition are key rate-limiting factors to functional recovery from psychotic disorders and include deficits in psychomotor speed, memory, attention, reasoning, and social cognition. The latter include deficits in perspective-taking, emotion perception and regulation, clearly linked to functional outcome in SZ. Perspective-taking (ability to understand the thoughts, feelings, and intentions of others) and emotion regulation (ability to have cognitive control over emotional stimuli) are critical for healthy social development; their impairment is a major contributor to social and functional disability. There is compelling evidence from recent meta-analyses that psychosocial approaches to cognitive remediation are effective in SZ. We have shown that a psychosocial cognitive rehabilitation known as Cognitive Enhancement Therapy (CET) substantially improves both social cognition and employment rates among patients with early course SZ. The effects were durable at 1 year following end of treatment. CET is a comprehensive, developmental approach to address social and non-social cognitive deficits in SZ; it seeks to facilitate the development of adult social-cognitive milestones (e.g., perspective-taking, social context appraisal) by shifting thinking from reliance on effortful, serial processing to a "gistful" and spontaneous abstraction of social themes (details about CET in section C.2.6). CET targets social-cognitive impairments in perspective-taking and emotion regulation through computerized training in basic neurocognitive processes, and the use of social-cognitive rehabilitation groups. The efficacy of CET for remediating social-cognitive impairments in perspective-taking and emotion regulation in SZ presumably reflects an underlying change in fronto-temporal brain function and connectivity during the course of treatment, made possible by the plasticity of the human brain. CET may also protect against gray matter loss, and even support fronto-temporal gray matter growth in service of social-cognitive enhancement in SZ. In this study, we plan to modify CET for individuals at CHR. We will develop a manual for CLUES and systematically test the acceptability, tolerability, adherence and preliminary proof of target engagement (part 1), and preliminary efficacy in a proof of concept open label trial (part 2). An important recent initiative in treatment development is to ensure informed, data-driven decisions early in clinical trials, i.e. to identify therapeutic targets, obtain evidence of target engagement and a proof of concept of efficacy prior to proceeding to expensive clinical trials. To pursue this goal, we will evaluate CET effects on cognition and social cognition in part 1 before efficacy testing in part 2. Overview: This study will be organized in two parts: Part 1: Preliminary open-label CLUES group (n=8) to verify target engagement (using cognition and social cognition measures), to evaluate feasibility and tolerability, and to iteratively refine the manual. Part 2: Small, randomized trial comparing CLUES (2 groups, n=15 each to a control condition (psychotherapy + an active computer-based program, Sporcle, with simple/ non-demanding computer games).CLUES Interventions in this part will be optimized based on part 1 results. Interventions: 1) Individualized assessment: The intervention begins with a comprehensive assessment of neurocognition and social cognition, as well as cognitive style. This informs development of an individualized coaching plan targeting the individual's areas of difficulty. The individualized coaching plan sets CET apart from other more standardized cognitive remediation approaches. 2) Neurocognitive remediation sessions. Weekly CET cognitive remediation sessions involve working with a partner (peer) and is facilitated by a clinician. This provides a unique opportunity for participants to complete "bottom up" cognitive exercises designed to improve processing speed, attention, memory and problem solving while also learning to negotiate the social tasks involved in working with a partner (e.g., making appropriate small talk, paying attention and keeping score while a partner engages in the tasks, providing encouragement when a partner struggles, and/or managing feelings that come up when the participant struggles more than their partner). 3) Social cognitive group: Participants take part in weekly social cognitive groups concurrently with neurocognitive training and individual sessions. This group is designed to help participants learn strategies for applying skills to improve non-social and social cognition and provide in vivo learning experiences to foster the development of social wisdom and interpersonal success. A broad, theoretically-driven array of social-cognitive abilities are targeted in the social cognitive groups, which range from abstracting the "gist" or main point in social interactions to perspective taking, social context appraisal, and emotion management. Participants actively engage in the social cognitive groups by responding to unrehearsed social exchanges, presenting homework, participating in cognitive exercises that focus on experiential learning, providing feedback to peers, and chairing homework sessions. 4) Individual coaching: Weekly individual coaching sessions provide opportunities for the intervention to be further tailored to the participants' specific goals, cognitive difficulties and cognitive style. Coaching sessions help the participant to develop a training plan, digest information and skills learned in social cognitive group and in the neurocognitive training sessions, and figure out how to apply them to make progress toward personal goals. Control treatment (Part 2 only): During part 1, all participants will take part in CLUES. During part 2, we will conduct a small randomized trial in which participants will be randomized to CLUES or the control intervention (n=15 each). The control intervention will consist of weekly supportive personal therapy plus 2 hours/ week of participation in Sporcle, a web-based, publicly available active computer-based, generic, quiz-type program. Sporcle provides quizzes on subject areas from geography to basic arithmetic to pop-culture. Sporcle includes games such as identifying popular logos, naming as many pictured fruits and vegetables as possible, and listing state capitols. Based on online user data and on level of difficulty, relatively easy exercises are chosen (averaging approximately 70% accuracy (i.e. 70% of quiz items correctly answered, on average). Games are presented to participants on "prescription cards" each week, with an aim of participating in 2 hours per week (equivalent to 1 hour of lumosity plus 1 hour per week paired computer training. In ST, patients meet individually with a therapist to learn and practice a variety of stress-reduction and illness management techniques. The ST approach is designed to be sensitive to the patient's stage of development and divided into 2 phases. The first, basic phase (0-3 months) focuses on psychoeducation about risk for psychosis (to be developed during phase 1), the role of stress in the disorder, and symptom exacerbation, and introduces basic coping strategies to minimize and/or avoid stress in one's life.The second, phase (4-6 months) advances to a personalized approach to the identification of early cues of distress and the application of healthy coping strategies to enhance adjustment. By tailoring the treatment to the patient's stage of recovery, Patients meet weekly with a therapist, although more frequent sessions are available if needed. We will seek to match the number of sessions or hours of treatment between CLUES and ST. Participants will be assessed at: 1) Baseline, 2) 3 months into the program, 3) at the time of completion of the program (6 months), and 4) 3 months following completion of CLUES, in the part 2 trial only (Table 1). All these assessments will be administered during part 1 to assess acceptability, applicability to the CHR population and assessment burden; Observations will then be used to optimize assessment battery for part 2.


Criteria:

Inclusion Criteria: Broad criteria for clinical high risk for psychosis including meeting for SIPS clinical high risk syndrome or any two of the following: - Trait risk: Having a first degree relative with a psychotic disorder, or a schizotypal disorder in the patient - Positive symptoms: One or more of the attenuated SOPS Positive or Disorganized items scoring mild (3), moderate (4) or severe (5) but not at a psychotic level; these may include one or more Basic Symptoms (Klosterkotter et al 2001). - Negative symptoms: Two or more of the SOPS negative symptoms rated at least moderate in severity - Cognition: executive cognitive impairment (at least 1.0 standard deviation deficit relative to age-expected norms on at least 30% of the measures - Functioning: GAF decline > 30% over the last 2 years, sustained for > 1 mo. Exclusion Criteria: - History of meeting full criteria for psychotic disorder - Significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury) - More than 6 months (lifetime) of exposure to antipsychotic treatment - A recent (within the past 3 months) history of substance abuse or dependence - IQ < 80 - Failure to achieve at least a 6th grade reading level - Persistent suicidal or homicidal behavior


Study is Available At:


Original ID:

2014P000285


NCT ID:

NCT02459210


Secondary ID:

1R34MH105596-01


Study Acronym:

CLUES


Brief Title:

Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis


Official Title:

CLUES (Cognition for Learning and for Understanding Everyday Social Situations): An Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

25 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beth Israel Deaconess Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

58


Enrollment Type:

Actual


Overall Contact Information

Official Name:Matcheri Keshavan, MD
Principal Investigator
Beth Israel Deaconess Medical Center/ Massachusetts Mental Health Center

Study Dates

Start Date:January 2015
Completion Date:January 2019
Completion Type:Actual
Primary Completion Date:January 2019
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 3, 2019
First Received Date:April 14, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Feasibility of treatment (Rates of attendance for all aspects of treatment)
Time Frame:6 months and 9 months
Safety Issues:False
Description:Rates of attendance for all aspects of treatment
Outcome Type:Secondary Outcome
Measure:Satisfaction with treatment (Self report of client satisfaction)
Time Frame:6 month and 9 months
Safety Issues:False
Description:Self report of client satisfaction
Outcome Type:Secondary Outcome
Measure:Change from Baseline in Social-cognitive functioning (neuropsychological test battery)
Time Frame:Baseline, 6 month, and 9 month
Safety Issues:False
Description:Assessed through administration of neuropsychological test battery
Outcome Type:Secondary Outcome
Measure:Change from Baseline in Neurocognitive functioning (neuropsychological test battery)
Time Frame:Baseline, 6 month, and 9 month
Safety Issues:False
Description:Assessed through administration of neuropsychological test battery
Outcome Type:Primary Outcome
Measure:Change from Baseline in Social and Role Functioning at 6 Month and 9 Month (clinical interview)
Time Frame:Baseline, 6 month, and 9 month
Safety Issues:False
Description:Assessed through clinical interview

Study Interventions

Intervention Type:Behavioral
Name:CLUES
Description:Cognition for learning and for understanding everyday social situations intervention described above
Arm Name:CLUES
Intervention Type:Behavioral
Name:therapy and computer games
Description:Weekly psychotherapy+ computer games such as sporcle
Arm Name:therapy and computer games

Study Arms

Study Arm Type:Active Comparator
Arm Name:therapy and computer games
Description:supportive therapy + computer games
Study Arm Type:Experimental
Arm Name:CLUES
Description:active treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Beth Israel Deaconess Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

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Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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