Back to resultsLifestyle Interventions for Generalized Anxiety Disorder
Primary Purpose
Aerobic Exercise, Stretching
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Stretching
Sponsored by
About this trial
This is an interventional treatment trial for Aerobic Exercise
Eligibility Criteria
Inclusion Criteria:
- Male and female participants, ages 18-65.
- Principal diagnosis of Generalized Anxiety Disorder.
- Willing to and capable of providing informed consent, attending all study visits, and complying with the protocol.
- Classified as either being at low risk or moderate risk for cardiovascular disease according to American College of Sports Medicine (ACSM) risk stratification guidelines (see "Telephone Prescreen and Risk Stratification" section for more information).
- Sedentary as defined by ACSM guidelines as not participating in at least 30 minutes of moderate-intensity exercise on at least 3 days a week for at least 3 months.
Exclusion Criteria:
- Currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia. Alcohol or drug dependence, abuse of depressants, dissociative anesthetics, hallucinogens, opioids, and cocaine within the last 6 months. Comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the protocol.
- Cognitive behavioral therapy within three months of baseline, or ongoing supportive therapy directed specifically toward the treatment of anxiety or mood disorder.
- Psychotropic medications are acceptable only if they are stabilized for at least 3 weeks prior to the baseline visit, as long they are not considered a relative or absolute contraindication to the use of any treatment option in the protocol.
- For women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.
- Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).
Sites / Locations
- BU Center for Anxiety and Related Disorders, Boston University
- Anxiety Research and Treatment Program, SMU Department of Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Aerobic exercise
stretching
Arm Description
The exercise intervention is a 12-week program involving 150 minutes of moderate intensity exercise (65-69% of participant's age-predicted [220-age] maximum heart rate) each week. Participants will complete one 50-minute supervised treadmill exercise session in the laboratory and 100 minutes of exercise on their own. These exercises may include walking, jogging, biking, or other forms of aerobic exercise. The at-home exercise regimen will be individualized for each participant.
The exercise intervention is a 12-week program involving 150 minutes of stretching each week (one 50-minute stretching session in the laboratory and 100 minutes of stretching at home). Participants in the stretching condition will work with a facilitator to create a stretching regimen for 100 minutes of home stretching throughout the week. The facilitator will provide a list of potential stretches with descriptions on how to perform them.
Outcomes
Primary Outcome Measures
Penn State worry Questionnaire
The PSWQ is a 16-item inventory designed to capture the generality, excessiveness, and uncontrollability of pathological worry. It has been shown to have good internal consistency with samples consisting of older adults with GAD
GAD-7
The GAD-7 is a self-reported questionnaire for screening and severity measurement of generalized anxiety disorder (GAD). The researchers conclude that the "GAD-7 is a valid and efficient tool" to screen for anxiety and to assess "its severity in clinical practice and research."
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
This questionnaire rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. The Q-LES-Q will be used to examine changes in quality of life with treatment.
Clinical Global Impressions Improvement/Severity (CGI)
The CGI-I is a measure of global improvement rated from 1 (very much improved) to 7 (very much worse). The CGI-S measures global severity rated from 1 (not ill) to 7 (extremely ill).
Secondary Outcome Measures
Beck Anxiety Inventory (BAI)
The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.
Beck Depression Inventory (BDI)
The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.
Anxiety Sensitivity
Anxiety sensitivity was measured using the Anxiety Sensitivity Index a 16-item questionnaire designed to assess one's tendency to respond fearfully to anxiety-related symptoms. Data on the reliability and validity of the ASI scales have been favorable .
Social Physique Anxiety
The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique.
Full Information
NCT ID
NCT01644812
First Posted
July 17, 2012
Last Updated
August 16, 2013
Sponsor
Southern Methodist University
Collaborators
Boston University
1. Study Identification
Unique Protocol Identification Number
NCT01644812
Brief Title
Lifestyle Interventions for Generalized Anxiety Disorder
Official Title
Lifestyle Interventions for Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Methodist University
Collaborators
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This two-site (Southern Methodist University (SMU) and Boston University (BU)) study aims to examine the effectiveness of exercise interventions for the treatment of generalized anxiety disorder (GAD). If effective, the use of exercise as a component of treatment for GAD would have a significant public health impact. In addition to improving GAD treatment outcome, exercise is expected to offer health benefits and promote further lifestyle changes.
The present study involves the randomization of 52 adults with GAD to either a 12-week combined supervised- home-based moderate-intensity aerobic exercise protocol (EX) or a 12-week combined supervised- home-based stretching protocol (CTRL). The investigators hypothesize that participants in the EX intervention will evidence greater improvements in anxiety symptoms and quality of life relative to individuals receiving the control intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aerobic Exercise, Stretching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
The exercise intervention is a 12-week program involving 150 minutes of moderate intensity exercise (65-69% of participant's age-predicted [220-age] maximum heart rate) each week. Participants will complete one 50-minute supervised treadmill exercise session in the laboratory and 100 minutes of exercise on their own. These exercises may include walking, jogging, biking, or other forms of aerobic exercise. The at-home exercise regimen will be individualized for each participant.
Arm Title
stretching
Arm Type
Sham Comparator
Arm Description
The exercise intervention is a 12-week program involving 150 minutes of stretching each week (one 50-minute stretching session in the laboratory and 100 minutes of stretching at home). Participants in the stretching condition will work with a facilitator to create a stretching regimen for 100 minutes of home stretching throughout the week. The facilitator will provide a list of potential stretches with descriptions on how to perform them.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Primary Outcome Measure Information:
Title
Penn State worry Questionnaire
Description
The PSWQ is a 16-item inventory designed to capture the generality, excessiveness, and uncontrollability of pathological worry. It has been shown to have good internal consistency with samples consisting of older adults with GAD
Time Frame
changes from baseline to week 13
Title
GAD-7
Description
The GAD-7 is a self-reported questionnaire for screening and severity measurement of generalized anxiety disorder (GAD). The researchers conclude that the "GAD-7 is a valid and efficient tool" to screen for anxiety and to assess "its severity in clinical practice and research."
Time Frame
changes from baseline to week 13
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
This questionnaire rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. The Q-LES-Q will be used to examine changes in quality of life with treatment.
Time Frame
changes from baseline to week 13
Title
Clinical Global Impressions Improvement/Severity (CGI)
Description
The CGI-I is a measure of global improvement rated from 1 (very much improved) to 7 (very much worse). The CGI-S measures global severity rated from 1 (not ill) to 7 (extremely ill).
Time Frame
changes from baseline to week 13
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.
Time Frame
changes from baseline to week 13
Title
Beck Depression Inventory (BDI)
Description
The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.
Time Frame
changes from baseline to week 13
Title
Anxiety Sensitivity
Description
Anxiety sensitivity was measured using the Anxiety Sensitivity Index a 16-item questionnaire designed to assess one's tendency to respond fearfully to anxiety-related symptoms. Data on the reliability and validity of the ASI scales have been favorable .
Time Frame
changes from baseline to week 13
Title
Social Physique Anxiety
Description
The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique.
Time Frame
changes from baseline to week 13
Other Pre-specified Outcome Measures:
Title
Health and Risk Assessment Screening.
Description
The American College of Sports Medicine risk stratification health screening (see Appendix) is a self-guided review of health and medical history for known diseases and signs, symptoms, and risk factors for cardiovascular disease. Female participants will also be administered a pregnancy test.
Time Frame
screening week 0
Title
Psychiatric Diagnoses
Description
Diagnostic exclusions and lifetime prevalence of Axis I diagnoses will be determined by the Structured Clinical Interview for DSM-IV non-patient version (SCID-NP; First et al., 2004) during Screening Visit 1. The SCID will be administered during by trained doctoral-level interviewers and will be supervised by the PIs, as has been done successfully in the past (e.g., Zvolensky, Leen-Feldner et al., 2004; Smits et al., 2009).
Time Frame
Screening week 0
Title
The Columbia Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is a standardized measure of current and past self-injurious behavior, suicidal intent, and suicidal behaviors. The C-SSRS has demonstrated good reliability and validity (Hammad et al., 2006; Posner et al., 2007). The C-SSRS will be administered at the Screening Visit.
Time Frame
Screening week 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female participants, ages 18-65.
Principal diagnosis of Generalized Anxiety Disorder.
Willing to and capable of providing informed consent, attending all study visits, and complying with the protocol.
Classified as either being at low risk or moderate risk for cardiovascular disease according to American College of Sports Medicine (ACSM) risk stratification guidelines (see "Telephone Prescreen and Risk Stratification" section for more information).
Sedentary as defined by ACSM guidelines as not participating in at least 30 minutes of moderate-intensity exercise on at least 3 days a week for at least 3 months.
Exclusion Criteria:
Currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia. Alcohol or drug dependence, abuse of depressants, dissociative anesthetics, hallucinogens, opioids, and cocaine within the last 6 months. Comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the protocol.
Cognitive behavioral therapy within three months of baseline, or ongoing supportive therapy directed specifically toward the treatment of anxiety or mood disorder.
Psychotropic medications are acceptable only if they are stabilized for at least 3 weeks prior to the baseline visit, as long they are not considered a relative or absolute contraindication to the use of any treatment option in the protocol.
For women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding.
Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).
Facility Information:
Facility Name
BU Center for Anxiety and Related Disorders, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Anxiety Research and Treatment Program, SMU Department of Psychology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
12. IPD Sharing Statement
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Lifestyle Interventions for Generalized Anxiety Disorder
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