Exercise and Markers of Medial Temporal Health in Youth At-risk for Psychosis

NCT02155699 | Completed Results DMC

• 2 other identifiers: CU 14-02004R33MH103231-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposal is to test the feasibility and effectiveness of cardiovascular exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that are not there, feeling emotionally detached from self and others), cognitive difficulties (troubles with memory and learning), and every day social-occupational functioning in youth at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding how exercise may protect or improve the health of a brain area that is implicated as a major contributing factor to the onset of psychosis may lead to a path-breaking new intervention that does not suffer from many of the side effects, costs, and other barriers that characterize treatments that are currently available for this group. Because a significant portion of high-risk youth go on to develop a psychotic disorder in a short period, intervening at this stage may help to improve the clinical course and ultimately prevent the onset of a devastating and prevalent mental illness.

Conditions

Attenuated Psychosis Syndrome

Keywords

UHR, Remediation, Exercise, Intervention, Psychosis

Outcome Measures

Primary Outcomes (1)

• Brain Volume

  Medial temporal structures (hippocampus and parahippocampal gyrus) will be delineated automatically using the FMRIB's Integrated Registration and Segmentation Tool algorithm within the FMRIB's Software Library (FSL) image-processing suite. Secondly, the structures will be evaluated with vertex analyses (assessing changes in shape post trial on a per-vertex basis), which will also be carried out utilizing FIRST. Shape/appearance models used in FIRST are constructed from manually segmented images provided by the Center for Morphometric Analysis (CMA, Boston). This approach is different from using a whole-structure summary measure like volume, as it allows visualization of the region of the shape that is changing as well as the type of shape change.

  pre-trial, post-trial (3-months)

Secondary Outcomes (1)

• Working Memory Assessment

  pre-trial, post-trial (3-months)

Other Outcomes (2)

• Attenuated Psychosis Positive Symptom Subscales

  pre-trial, post-trial (3-months)

• Aerobic Fitness

  pre-trial, post-trial (3 months)

Study Arms (3)

Exercise 1

EXPERIMENTAL

65% of V02 Max, 3x per week, 3 months

Behavioral: Exercise 1

Exercise 2

EXPERIMENTAL

85% of VO2 Max, 2x per week, 3 months

Behavioral: Exercise 2

Waitlist

NO INTERVENTION

Waitlist (three months)

Interventions

Exercise 1 BEHAVIORAL

65% of VO2max and 2 sessions per week

Exercise 1

Exercise 2 BEHAVIORAL

85% intensity and 3 sessions per peek

Exercise 2

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 16-24
• no history of brain injury or neurological disease
• no contraindications to exercise training (as assessed by a Clinical Translational Research Center CTRC physician)
• no history or current treatment with antipsychotics
• no contraindications for being in an magnetic resonance imaging scanner.
• meet criteria for a prodromal syndrome based upon the Structure Interview for Prodromal Syndromes (SIPS) interview.

You may not qualify if:

• people who are extremely claustrophobic
• have a history of significant head injury
• other physical disorder that could affect brain functioning
• mental retardation
• history of substance use disorder within 6 months of screening interview
• have a psychotic disorder (at study entry) and/or have exhibited serious self-harm behaviors
• pregnant females
• people who have contraindications to magnetic resonance (MR) scanning including intracranial, intraorbital or intraspinal metal, pacemakers, cochlear implants or other non-MR-compatible devices
• inability of the subject or their parent/guardian to understand the informed consent document
• meeting criteria for an Axis I psychotic disorder

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Northwestern University: collaborator

Study Sites (1)

ADAPT Program

Boulder, Colorado, 80309, United States

Location

Related Publications (7)

• Mittal VA, Gupta T, Orr JM, Pelletier-Baldelli A, Dean DJ, Lunsford-Avery JR, Smith AK, Robustelli BL, Leopold DR, Millman ZB. Physical activity level and medial temporal health in youth at ultra high-risk for psychosis. J Abnorm Psychol. 2013 Nov;122(4):1101-10. doi: 10.1037/a0034085.

  PMID: 24364613 BACKGROUND

• Miller 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.

  PMID: 14989408 BACKGROUND

• Niendam TA, Bearden CE, Zinberg J, Johnson JK, O'Brien M, Cannon TD. The course of neurocognition and social functioning in individuals at ultra high risk for psychosis. Schizophr Bull. 2007 May;33(3):772-81. doi: 10.1093/schbul/sbm020. Epub 2007 Apr 9.

  PMID: 17420177 BACKGROUND

• Ragland JD, Ranganath C, Barch DM, Gold JM, Haley B, MacDonald AW 3rd, Silverstein SM, Strauss ME, Yonelinas AP, Carter CS. Relational and Item-Specific Encoding (RISE): task development and psychometric characteristics. Schizophr Bull. 2012 Jan;38(1):114-24. doi: 10.1093/schbul/sbr146. Epub 2011 Nov 28.

  PMID: 22124089 BACKGROUND

• Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.

  PMID: 18172019 BACKGROUND

• Patenaude B, Smith SM, Kennedy DN, Jenkinson M. A Bayesian model of shape and appearance for subcortical brain segmentation. Neuroimage. 2011 Jun 1;56(3):907-22. doi: 10.1016/j.neuroimage.2011.02.046. Epub 2011 Feb 23.

  PMID: 21352927 BACKGROUND

• Dean DJ, Bryan AD, Newberry R, Gupta T, Carol E, Mittal VA. A Supervised Exercise Intervention for Youth at Risk for Psychosis: An Open-Label Pilot Study. J Clin Psychiatry. 2017 Nov-Dec;78(9):e1167-e1173. doi: 10.4088/JCP.16m11365.

  PMID: 29178684 DERIVED

Related Links

• ADAPT Program Study Site Providing Details for the Clinical Trial

MeSH Terms

Conditions

Motor Activity; Psychotic Disorders

Condition Hierarchy (Ancestors)

Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

It is a notable limitation that the current sample size is small; however, the current sample size is comparable or larger than extant randomized control studies in psychosis CHR-p individuals make up a heterogenous population future studies should consider heterogeneity in clinical and cognitive symptoms in larger samples. There are several benefits of exercise not examined by the current study.

Results Point of Contact

• Title: Dr. Vijay A Mittal
• Organization: Northwestern University

vijay.mittal@northwestern.edu

847-467-3880

Study Officials

• Vijay A Mittal, Ph.D.

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Angela Bryan, Ph.D.

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 2, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-03

Locations

US (1)