Exercise for Depressed Smokers

Aerobic Exercise for Smokers With Depressive Symptomatology

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).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Smoking
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. are between 18 and 65 years of age
2. are current smokers (i.e., smoking at least 10 cigarettes per day)
3. have currently elevated depressive symptoms (CES-D ≥ 6)
4. 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:

1. DSM-IV diagnosis of current mania
2. DSM-IV diagnosis of bipolar rapid cycling
3. lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
4. DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
5. DSM-IV diagnosis of anorexia or bulimia nervosa
6. current suicidality or homicidality
7. marked organic impairment
8. current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
9. physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
10. current pregnancy or intent to become pregnant during the next 12 weeks
11. 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)
12. current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
13. current use of any pharmacotherapy or other treatment for smoking cessation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 12-week moderate-intensity behavioral exercise intervention (AE)	Behavioral: Aerobic Exercise; 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.
Active Comparator: Health Education; 12-week health education control	Behavioral: Health Education; 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.

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ana M. Abrantes, Ph.D., Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Smoking; Tobacco; Quit smoking
• Other Study ID Numbers: 1304-001; R01CA173551 (U.S. NIH Grant/Contract)