Exercise for Depressed Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).

Official Title
-----------------
Aerobic Exercise for Smokers With Depressive Symptomatology

Conditions
-----------------
Tobacco Smoking, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Aerobic Exercise
* Behavioral: Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are between 18 and 65 years of age are current smokers (i.e., smoking at least 10 cigarettes per day) have currently elevated depressive symptoms (CES-D ≥ 6) are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months) Exclusion Criteria: DSM-IV diagnosis of current mania DSM-IV diagnosis of bipolar rapid cycling lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms DSM-IV diagnosis of current substance abuse or dependence in the past 6 months DSM-IV diagnosis of anorexia or bulimia nervosa current suicidality or homicidality marked organic impairment current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months, physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance) current pregnancy or intent to become pregnant during the next 12 weeks contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch) current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin) current use of any pharmacotherapy or other treatment for smoking cessation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>12-week moderate-intensity behavioral exercise intervention (AE) | Behavioral: Aerobic Exercise<br>* 12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. Two month course of the nicotine patch initiated during week 5.<br>|
| Active Comparator: Health Education<br>12-week health education control | Behavioral: Health Education<br>* 12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation | Abstinence from smoking verified biochemically (saliva cotinine) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quit smoking, Exercise, Tobacco, Smoking