Pilot Study of the Impact of Exercise on Hippocampal Function
1 other identifier
interventional
14
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Mar 2017
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2018
CompletedMarch 27, 2019
March 1, 2019
1.5 years
January 3, 2017
March 25, 2019
Conditions
Keywords
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
EXPERIMENTALhome exercise sessions
Interventions
6 week at-home aerobic exercise protocol
Eligibility Criteria
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
- New York State Psychiatric Institutelead
- Columbia Universitycollaborator
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen B Simpson, M.D, Ph.D.
New York State Psychiatric Institute
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.