Efficacy of Exercise and Counseling Intervention on Relapse in Smoker With Depressive Disorders (STOB-ACTIV)

This study has been terminated.
(Difficulties for recruiting patients)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01401569
First received: July 21, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Depression
Behavioral: Exercise and counseling (for smoking cessation and physical activity)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Evaluation of smoking cessation verified by expired air carbon monoxide [ Time Frame: 12 weeks after baseline ] [ Designated as safety issue: No ]
    To evaluate whether adding an established exercise and counseling intervention for depressed smokers to a standard smoking cessation treatment program improves smoking outcomes to 12 weeks after baseline ( 7-day point prevalence smoking abstinence verified by expired air carbon monoxide).


Secondary Outcome Measures:
  • prevalence smoking abstinence [ Time Frame: (Baseline, 8, 12, 24, 52 weeks after baseline) ] [ Designated as safety issue: No ]
    7-day point prevalence smoking abstinence verified by expired air carbon monoxide

  • Evaluation of Anxiety and Depression [ Time Frame: Baseline; 8, 12, 24, 52 weeks after baseline ] [ Designated as safety issue: No ]
    The Anxiety and Depression are evaluated by the specific Scale (HADS)

  • Physical Fitness/Activity [ Time Frame: Baseline, 8 weeks 12, 24, 52 weeks after baseline ] [ Designated as safety issue: No ]
    Physical Fitness/Activity are evaluated by the 6 minutes Walk Test or TDM6 (Time Frame: Baseline; 8weeks after baseline), by Accelerometry (Time Frame: Baseline; -1, 9 weeks), by the evaluation of Physical self esteem (Time Frame: Baseline; 8, 12 weeks after baseline)with a self-questionnaire (IPAQ7)

  • Evaluation of Weight [ Time Frame: Baseline; 8,12, 24, 52 weeks after baseline ] [ Designated as safety issue: No ]
  • Evaluation of quality of life [ Time Frame: Baseline; 8, 12 weeks after baseline ] [ Designated as safety issue: No ]
    The quality of life is evaluated by a self-questionnaire (SF-12)

  • Cigarette Craving [ Time Frame: Baseline; 8, 12 weeks after baseline ] [ Designated as safety issue: No ]
    The Cigarette Craving is evaluated by self-questionnaires: QSU and Fagerström test

  • Smoking Abstinence self Efficacy [ Time Frame: Baseline; 8, 12 weeks after baseline ] [ Designated as safety issue: No ]
    The Smoking Abstinence self Efficacy is evaluated by the self-questionnaire (CSQ 12)


Enrollment: 70
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
All subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy or varenicline) and counseling.
Behavioral: Exercise and counseling (for smoking cessation and physical activity)
Exercise and counseling (for smoking cessation and physical activity)
Experimental: physical activity program
Experimental group subjects were required to attend 2 supervised exercise sessions and 2 counseling sessions during Week 1 and Week 2. Supervised exercise and counseling sessions are realized successively. For Week 3 to 8, participants were required to attend 1 supervised exercise session and 1 counseling session plus 1 home exercise session.
Behavioral: Exercise and counseling (for smoking cessation and physical activity)
Exercise and counseling (for smoking cessation and physical activity)

Detailed Description:

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 group delivered exercise and counseling (for smoking cessation and physical activity) or a health education contact control condition. The investigators assess this intervention in a randomized controlled trial of 96 depressed adults smokers recruited by advertisements in local print allocated into one of the two groups (intervention group vs. control group) during a 8-week period and 3 follow-up visits (12, 24, 52 weeks after baseline). All subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy or varenicline) and counseling.Experimental group subjects were required to attend 2 supervised exercise sessions and 2 counseling sessions during Week 1 and Week 2. Supervised exercise and counseling sessions are realized successively. For Week 3 to 8, participants were required to attend 1 supervised exercise session and 1 counseling session plus 1 home exercise session.Supervized exercise session consist of 5-min warm-up, 30 min of aerobic activity (stationary bikes), and a 5-min cooldown with stretching. The training intensity is of 60 to 80% maximum heart rate. The sessions are supervised by an exercise specialist who verified and documented the heart rates. Home exercise session consist of 45 min of aerobic exercise (walking, cycling, or running). The training intensity is 6 to 7 on breathlessness visual analog scale.The smoking counseling sessions included the following components: review of a participant's smoking history and motivation to quit, help in the identification of high-risk situations, management of cigarette craving and the generation of problem-solving strategies to deal with such situations.Exercise counseling sessions designed to motivate increased regular physical activity and short bouts of exercise in response to negative affect and urges to smoke. The goal of this intervention was to increase activity level.Health education group subjects were required to participate 75-minute supervised sessions with the same frequency of experimental group. Participants in the health education condition received information on a variety of health topics including sleep hygiene, nutrition, stress and health screening tests for cancer prevention. Participants were also asked to read handouts on health education topics covered during the session.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401569

Locations
France
University Hospital
Montpellier, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01401569     History of Changes
Other Study ID Numbers: UF 8608, n°ID RCB 2010-A00119-30
Study First Received: July 21, 2011
Last Updated: June 12, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Exercise,
counseling,
smoking cessation,
depressive disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Smoking
Behavioral Symptoms
Mood Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on April 17, 2014