Lifestyle Interventions for Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01644812
Recruitment Status : Terminated
First Posted : July 19, 2012
Last Update Posted : August 20, 2013
Boston University
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University

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.

Condition or disease Intervention/treatment Phase
Aerobic Exercise Stretching Behavioral: Aerobic exercise Behavioral: Stretching Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Interventions for Generalized Anxiety Disorder
Study Start Date : March 2012
Actual Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Aerobic exercise
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.
Behavioral: Aerobic exercise
Sham Comparator: stretching
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.
Behavioral: Stretching

Primary Outcome Measures :
  1. Penn State worry Questionnaire [ Time Frame: changes from baseline to week 13 ]
    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

  2. GAD-7 [ Time Frame: changes from baseline to week 13 ]
    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."

  3. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: changes from baseline to week 13 ]
    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.

  4. Clinical Global Impressions Improvement/Severity (CGI) [ Time Frame: changes from baseline to week 13 ]
    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 :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: changes from baseline to week 13 ]
    The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.

  2. Beck Depression Inventory (BDI) [ Time Frame: changes from baseline to week 13 ]
    The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.

  3. Anxiety Sensitivity [ Time Frame: changes from baseline to week 13 ]
    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 .

  4. Social Physique Anxiety [ Time Frame: changes from baseline to week 13 ]
    The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique.

Other Outcome Measures:
  1. Health and Risk Assessment Screening. [ Time Frame: screening week 0 ]
    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.

  2. Psychiatric Diagnoses [ Time Frame: Screening week 0 ]
    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).

  3. The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Screening week 0 ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01644812

United States, Massachusetts
BU Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, United States, 02215
United States, Texas
Anxiety Research and Treatment Program, SMU Department of Psychology
Dallas, Texas, United States, 75206
Sponsors and Collaborators
Southern Methodist University
Boston University

Responsible Party: Jasper Smits, Ph.D., Associate Professor, Southern Methodist University Identifier: NCT01644812     History of Changes
Other Study ID Numbers: 2012-001-SMIJ-N
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders