NCT03036371

Brief Summary

The goal of this pilot study is to test the procedural aspects of the behavioral tests and the exercise components of the study. This includes establishing typical scores for anxiety patients in these behavioral tests, and administering and coaching anxiety patients in an at-home exercise regimen. This pilot study will produce the information necessary to design a larger future study including both patients and healthy control participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

January 3, 2017

Last Update Submit

March 25, 2019

Conditions

Keywords

NeurogenesisMemorySpatial ProcessingHippocampusCognitionAerobic Exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Percent Correct Score for the Treasure Hunt Task (THT)

    change between baseline and 6 weeks

    6 weeks

Secondary Outcomes (4)

  • Change in Percent Correct Score for the Mnemonic Similarity Test (MST)

    6 weeks

  • Change in Depression, Anxiety, and Stress Scale (DASS)

    6 weeks

  • Change in Intolerance of Uncertainty Scale (IUS)

    6 weeks

  • Change in Baecke Physical Activity Questionnaire

    6 weeks

Study Arms (1)

High Intensity Interval Exercise

EXPERIMENTAL

home exercise sessions

Behavioral: High Intensity Interval Exercise

Interventions

6 week at-home aerobic exercise protocol

High Intensity Interval Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A primary diagnosis of Obsessive Compulsive Disorder (OCD), Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD), Panic Disorder (PD), and/or Specific Phobia (SP)
  • No use of psychiatric medication in the past 4 weeks (or 8 weeks for fluoxetine)
  • Age 18-40
  • Ability to tolerate a treatment-free period
  • English-speaking
  • Body Mass Index (BMI) within normal range
  • Willing and able to sign consent form and comply with study procedures

You may not qualify if:

  • Current or lifetime comorbid psychiatric conditions that significantly elevate the risk of study participation
  • Any major medical or neurological problem that might interfere with reliable performance of study tasks or their interpretation, or render participation dangerous
  • Pregnant or lactating
  • Use of medication that alters the brain
  • Clinical symptom severity warranting immediate treatment
  • Current rigorous exercise program
  • Participation in Cognitive Behavioral Therapy (CBT) psychotherapy for anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anxiety DisordersSpatial Processing

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Mental DisordersSpatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Helen B Simpson, M.D, Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychiatry

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 30, 2017

Study Start

March 28, 2017

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

This is a pilot study intended to assess the feasibility of an at-home exercise protocol in a patient population, and to measure within-patient changes from baseline to post-exercise in order to calculate sample sizes needed for a full study. Therefore, the investigators do not plan to share the data of this small pilot study with other researchers.

Locations