Lifestyle Interventions for Generalized Anxiety Disorder

Aerobic Exercise Clinical Trial

Official title:

Lifestyle Interventions for Generalized Anxiety Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01644812
• Other study ID #: 2012-001-SMIJ-N
• Status: Terminated
• Phase: N/A
• First received: July 17, 2012
• Last updated: August 16, 2013
• Start date: March 2012

Study information

• Verified date: August 2013
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aerobic Exercise
• Anxiety Disorders
• Stretching

Intervention

Behavioral:
• Aerobic exercise

• Stretching

Locations

Country	Name	City	State
United States	BU Center for Anxiety and Related Disorders, Boston University	Boston	Massachusetts
United States	Anxiety Research and Treatment Program, SMU Department of Psychology	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southern Methodist University	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health and Risk Assessment Screening.	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.	screening week 0	No
Other	Psychiatric Diagnoses	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).	Screening week 0	No
Other	The Columbia Suicide Severity Rating Scale (C-SSRS)	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.	Screening week 0	No
Primary	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	changes from baseline to week 13	No
Primary	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."	changes from baseline to week 13	No
Primary	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.	changes from baseline to week 13	No
Primary	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).	changes from baseline to week 13	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.	changes from baseline to week 13	No
Secondary	Beck Depression Inventory (BDI)	The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.	changes from baseline to week 13	No
Secondary	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 .	changes from baseline to week 13	No
Secondary	Social Physique Anxiety	The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique.	changes from baseline to week 13	No