TerminatedPhase 3

Efficacy of Exercise and Counseling Intervention on Relapse in Smoker With Depressive Disorders

Stopped: Difficulties for recruiting patients

France70 participantsStarted 2010-10

Plain-language summary

This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 18 to 65 years * Must be able to give informed consent * Must live in the area for the next 3 months * Depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8 * Fagerstrom score \> 3 * Must be sedentary, have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months. * Must be able to exercise at 60% maximum heart rate (MHR) (cleared by a physician) Exclusion Criteria: * Cannot read or write fluently in the French language * Pregnancy or plans to attempt pregnancy * 60 minutes or more per week of moderate or vigorous physical activity * Currently in a quit smoking program * Currently using NRT of any kind or using any other quit smoking method or treatment * Poor willingness or inability to comply with protocol requirements Medical problems: * Cancer treatment within the past 6 monthsPsychiatric Problems * Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months) * Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal) * Currently diagnosis of a bipolar disorder as assessed by MINI 5.0 * Currently diagnosis of a alcohol dependence as assessed by MINI 5.0

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of smoking cessation verified by expired air carbon monoxide

Timeframe: 12 weeks after baseline

Trial details

NCT IDNCT01401569

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Smoking Cessation trials