Exercise for Depressed Smokers

NCT ID: NCT02086149

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-02-28

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).

Conditions

Tobacco Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

12-week moderate-intensity behavioral exercise intervention (AE)

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

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.

Health Education

12-week health education control

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana M. Abrantes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R01CA173551

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1304-001

Identifier Type: -

Identifier Source: org_study_id