Lifestyle Interventions for Generalized Anxiety Disorder

NCT01644812 | Terminated

• 1 other identifier: 2012-001-SMIJ-N
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Aerobic Exercise; Stretching

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Beck Anxiety Inventory (BAI)

  changes from baseline to week 13

• Beck Depression Inventory (BDI)

  changes from baseline to week 13

• Anxiety Sensitivity

  changes from baseline to week 13

• Social Physique Anxiety

  changes from baseline to week 13

Other Outcomes (3)

• Health and Risk Assessment Screening.

  screening week 0

• Psychiatric Diagnoses

  Screening week 0

• The Columbia Suicide Severity Rating Scale (C-SSRS)

  Screening week 0

Study Arms (2)

Aerobic exercise

ACTIVE COMPARATOR

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

stretching

SHAM COMPARATOR

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

Interventions

Aerobic exercise BEHAVIORAL

Aerobic exercise

Stretching BEHAVIORAL

stretching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Southern Methodist University: lead
• Boston University: collaborator

Study Sites (2)

BU Center for Anxiety and Related Disorders, Boston University

Boston, Massachusetts, 02215, United States

Location

Anxiety Research and Treatment Program, SMU Department of Psychology

Dallas, Texas, 75206, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

US (2)