Smoking CessationPhase 3STOB-ACTIVNCT01401569
Efficacy of Exercise and Counseling Intervention on Relapse in Smoker With Depressive Disorders
A Phase 3 study testing Exercise and counseling (for smoking cessation and physical activity) in people with Smoking Cessation and Depression, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Depression
- What is being tested?
- Exercise and counseling (for smoking cessation and physical activity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Smoking Cessation, Depression
- Being tested
- Exercise and counseling (for smoking cessation and physical activity)
- Keywords
- Exercise,, counseling,, smoking cessation,, depressive disorders
- Medical subject headings
- Smoking Cessation, Depression, Motor Activity, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and counseling (for smoking cessation and physical activity)Behavioural
Exercise and counseling (for smoking cessation and physical activity)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Behavioral: Exercise and counseling (for smoking cessation and physical activity) |
| physical activity program | Experimental | 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. Receives: Behavioral: Exercise and counseling (for smoking cessation and physical activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of smoking cessation verified by expired air carbon monoxide
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).
Measured: 12 weeks after baseline
Secondary outcomes (7)
prevalence smoking abstinence
7-day point prevalence smoking abstinence verified by expired air carbon monoxide
Measured: (Baseline, 8, 12, 24, 52 weeks after baseline)
Evaluation of Anxiety and Depression
The Anxiety and Depression are evaluated by the specific Scale (HADS)
Measured: Baseline; 8, 12, 24, 52 weeks after baseline
Physical Fitness/Activity
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)
Measured: Baseline, 8 weeks 12, 24, 52 weeks after baseline
Evaluation of Weight
Measured: Baseline; 8,12, 24, 52 weeks after baseline
Evaluation of quality of life
The quality of life is evaluated by a self-questionnaire (SF-12)
Measured: Baseline; 8, 12 weeks after baseline
Cigarette Craving
The Cigarette Craving is evaluated by self-questionnaires: QSU and Fagerström test
Measured: Baseline; 8, 12 weeks after baseline
Smoking Abstinence self Efficacy
The Smoking Abstinence self Efficacy is evaluated by the self-questionnaire (CSQ 12)
Measured: Baseline; 8, 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Difficulties for recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401569
- Sponsor's protocol ID
- 8608
- Other IDs
- n°ID RCB 2010-A00119-30
- Acronym
- STOB-ACTIV
- Status last verified
- May 2016
- First submitted
- 21 Jul 2011
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902Bernard P, Ninot G, Cyprien F, Courtet P, Guillaume S, Georgescu V, Picot MC, Taylor A, Quantin X. Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial. J Dual Diagn. 2015;11(3-4):205-16. doi: 10.1080/15504263.2015.1113842.
PubMed 26683252
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01401569
- Acronym / sponsor ID
- STOB-ACTIV / 8608
- Conditions
- Smoking Cessation, Depression
- Keywords
- Exercise,, counseling,, smoking cessation,, depressive disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties for recruiting patients
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Exercise and counseling (for smoking cessation and physical activity)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. |
| physical activity program | Experimental | Behavioral: Exercise and counseling (for smoking cessation and physical activity)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and counseling (for smoking cessation and physical activity)Exercise and counseling (for smoking cessation and physical activity) | Behavioural | Control, physical activity program |
Primary outcome
Evaluation of smoking cessation verified by expired air carbon monoxide
Time frame: 12 weeks after baseline
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).
7 secondary outcomes
prevalence smoking abstinence
Time frame: (Baseline, 8, 12, 24, 52 weeks after baseline)
Evaluation of Anxiety and Depression
Time frame: Baseline; 8, 12, 24, 52 weeks after baseline
Physical Fitness/Activity
Time frame: Baseline, 8 weeks 12, 24, 52 weeks after baseline
Evaluation of Weight
Time frame: Baseline; 8,12, 24, 52 weeks after baseline
Evaluation of quality of life
Time frame: Baseline; 8, 12 weeks after baseline
Cigarette Craving
Time frame: Baseline; 8, 12 weeks after baseline
Smoking Abstinence self Efficacy
Time frame: Baseline; 8, 12 weeks after baseline
Results and safety
The study was stopped early (reason given: Difficulties for recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Derived from this study: PubMed 26683252Bernard P, Ninot G, Cyprien F, Courtet P, Guillaume S, Georgescu V, Picot MC, Taylor A, Quantin X. Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial. J Dual Diagn. 2015;11(3-4):205-16. doi: 10.1080/15504263.2015.1113842.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and counseling (for smoking cessation and physical activity) in people with Smoking Cessation and Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties for recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of smoking cessation verified by expired air carbon monoxide (time frame: 12 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.