Clinical trial NCT01644812: Lifestyle Interventions for Generalized Anxiety Disorder
Official title: Lifestyle Interventions for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aerobic Exercise
Stretching
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2012-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Penn State worry Questionnaire
timeFrame: changes from baseline to week 13
measure: GAD-7
timeFrame: changes from baseline to week 13
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: changes from baseline to week 13
measure: Clinical Global Impressions Improvement/Severity (CGI)
timeFrame: changes from baseline to week 13
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: changes from baseline to week 13
measure: Beck Depression Inventory (BDI)
timeFrame: changes from baseline to week 13
measure: Anxiety Sensitivity
timeFrame: changes from baseline to week 13
measure: Social Physique Anxiety
timeFrame: changes from baseline to week 13
Other outcomes:
measure: Health and Risk Assessment Screening.
timeFrame: screening week 0
measure: Psychiatric Diagnoses
timeFrame: Screening week 0
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening week 0
Locations:
city: Boston
country: United States
facility: BU Center for Anxiety and Related Disorders, Boston University
state: Massachusetts
city: Dallas
country: United States
facility: Anxiety Research and Treatment Program, SMU Department of Psychology
state: Texas
Study officials:
References: