Mental DisorderQUITMENTALNCT03230955
Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients
A study testing Psychological and psycho-educational support by phone and Brief counselling session in people with Mental Disorder and Smoking Cessation, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively… Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Smoking Cessation, Motivation
- What is being tested?
- Psychological and psycho-educational support by phone and Brief counselling session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2017to 31 Dec 2020
- Phase
- Interventional
- 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 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smokers;
- adults of both sexes ≥ 18 years to ≤76 years of age;
- that have stayed in an Acute or Detoxification mental health unit for more than 24 hours;
- with a telephone, fixed or mobile;
- residents in the metropolitan area of Barcelona;
- that provide their informed consent.
Who cannot join
- patient discharged from the psychiatric emergency room;
- with dementia or brain damage;
- that do not speak Spanish or Catalan;
- pregnant women;
- with hearing and/or speech deficit;
- with insufficient reading comprehension skills in Spanish or Catalan;
Show all 9Show fewer
- that are trying to quit in smoking in another centre, or using another intervention in that moment;
- that have voluntarily requested discharge;
- that plan to shift their domicile outside of Barcelona county.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial
Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge.
To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
Read the detailed description
Background: People suffering from mental illness are more likely to smoke. In Spain, up to 75% of patients hospitalized for mental disorders smoke, tripling the general population consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25 years in comparison to the general population, mainly due to diseases caused or worsened by smoking. Hospitalized patients without monitoring after discharge quickly restore their tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up intervention to prevent relapse after discharge and achieve higher rates of withdrawal in this population.
Objectives: To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. The sample size, calculated with an expected difference of 15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG) and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent variables: self-reported smoking abstinence and verified by expired carbon monoxide levels, quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to achieve one abstinent will be calculated.
Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention is effective, the pragmatic nature of the study will permit to transfer it to the routine clinical practice with a reasonable investment.
- Conditions
- Mental Disorder, Smoking Cessation, Motivation
- Being tested
- Psychological and psycho-educational support by phone, Brief counselling session
- Keywords
- Randomized clinical trial, Hotlines
- Medical subject headings
- Mental Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and psycho-educational support by phoneBehavioural
Also called Telephone-based motivational intervention
The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)
Brief counselling sessionOther
Also called Brief advice
Brief counselling session
| Study group | Role | What they receive |
|---|---|---|
| Psychological and psycho-educational support | Experimental | The intervention group (IG) [that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process] Receives: Behavioral: Psychological and psycho-educational support by phone |
| Control Group | Active comparator | The control group (CG) [that will receive only a brief counselling session after discharge] Receives: Other: Brief counselling session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from tobacco consumption abstinence at 12 months
Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Change in the level of self-efficacy to quit smoking
Change of self reported self-efficacy (using a Likert scale from 0 to 10)
Measured: through study completion, an average of 1 year
Change of motivation to quit smoking (stage of change)
The Stages of Change Model helps to know the patient's motivation to quit, or stage of change, in order to allow clinicians to tailor interventions according to each stage (Prochaska, 1992).
Measured: through study completion, an average of 1 year
Attempts to quit smoking
Number of serious quit attempts after discharge
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start2 May 2017
- Primary completion31 May 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon "quit line" who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hestia Alliance
- Responsible party
- Sponsor
- Investigators
- Cristina Martínez, RN,BA, PhD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230955
- Sponsor's protocol ID
- 061 QUIT_MENTAL PI15/00875
- Acronym
- QUITMENTAL
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2017
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers
Publications
Ballbe M, Martinez C, Salto E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernandez E. Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain. Addict Behav. 2015 Mar;42:136-9. doi: 10.1016/j.addbeh.2014.11.028. Epub 2014 Nov 26.
PubMed 25462661Ballbe M, Nieva G, Mondon S, Pinet C, Bruguera E, Salto E, Fernandez E, Gual A; Smoking and Mental Health Group. Smoke-free policies in psychiatric services: identification of unmet needs. Tob Control. 2012 Nov;21(6):549-54. doi: 10.1136/tobaccocontrol-2011-050029. Epub 2011 Sep 20.
PubMed 21933940Ballbe M, Sureda X, Martinez-Sanchez JM, Salto E, Gual A, Fernandez E. Second-hand smoke in mental healthcare settings: time to implement total smoke-free bans? Int J Epidemiol. 2013 Jun;42(3):886-93. doi: 10.1093/ije/dyt014. Epub 2013 Mar 29.
PubMed 23543600Ballbe M, Sureda X, Martinez-Sanchez JM, Fu M, Salto E, Gual A, Fernandez E. Secondhand smoke in psychiatric units: patient and staff misperceptions. Tob Control. 2015 Oct;24(e3):e212-20. doi: 10.1136/tobaccocontrol-2014-051585. Epub 2014 Sep 19.
PubMed 25239470Banham L, Gilbody S. Smoking cessation in severe mental illness: what works? Addiction. 2010 Jul;105(7):1176-89. doi: 10.1111/j.1360-0443.2010.02946.x. Epub 2010 May 11.
PubMed 20491721Chabrol H, Niezborala M, Chastan E, de Leon J. Comparison of the Heavy Smoking Index and of the Fagerstrom Test for Nicotine Dependence in a sample of 749 cigarette smokers. Addict Behav. 2005 Aug;30(7):1474-7. doi: 10.1016/j.addbeh.2005.02.001.
PubMed 16022945Fiore MC, Baker TB. Clinical practice. Treating smokers in the health care setting. N Engl J Med. 2011 Sep 29;365(13):1222-31. doi: 10.1056/NEJMcp1101512.
PubMed 21991895Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25.
PubMed 12745503Martinez C, Fu M, Martinez-Sanchez JM, Ballbe M, Puig M, Garcia M, Carabasa E, Salto E, Fernandez E. Tobacco control policies in hospitals before and after the implementation of a national smoking ban in Catalonia, Spain. BMC Public Health. 2009 May 28;9:160. doi: 10.1186/1471-2458-9-160.
PubMed 19473549Martinez C, Guydish J, Le T, Tajima B, Passalacqua E. Predictors of quit attempts among smokers enrolled in substance abuse treatment. Addict Behav. 2015 Jan;40:1-6. doi: 10.1016/j.addbeh.2014.08.005. Epub 2014 Aug 27.
PubMed 25218064Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.
PubMed 21665792Morris CD, Waxmonsky JA, May MG, Tinkelman DG, Dickinson M, Giese AA. Smoking reduction for persons with mental illnesses: 6-month results from community-based interventions. Community Ment Health J. 2011 Dec;47(6):694-702. doi: 10.1007/s10597-011-9411-z. Epub 2011 May 10.
PubMed 21556784Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health. 2014 Aug;104(8):1557-65. doi: 10.2105/AJPH.2013.301403. Epub 2013 Aug 15.
PubMed 23948001Twyman L, Bonevski B, Paul C, Bryant J. Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open. 2014 Dec 22;4(12):e006414. doi: 10.1136/bmjopen-2014-006414.
PubMed 25534212
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT03230955
- Acronym / sponsor ID
- QUITMENTAL / 061 QUIT_MENTAL PI15/00875
- Conditions
- Mental Disorder, Smoking Cessation, Motivation
- Keywords
- Randomized clinical trial, Hotlines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hestia Alliance
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge.
To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
Detailed description
Background: People suffering from mental illness are more likely to smoke. In Spain, up to 75% of patients hospitalized for mental disorders smoke, tripling the general population consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25 years in comparison to the general population, mainly due to diseases caused or worsened by smoking. Hospitalized patients without monitoring after discharge quickly restore their tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up intervention to prevent relapse after discharge and achieve higher rates of withdrawal in this population.
Objectives: To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. The sample size, calculated with an expected difference of 15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG) and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent variables: self-reported smoking abstinence and verified by expired carbon monoxide levels, quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to achieve one abstinent will be calculated.
Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention is effective, the pragmatic nature of the study will permit to transfer it to the routine clinical practice with a reasonable investment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon "quit line" who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.
| Arm | Type | Receives |
|---|---|---|
| Psychological and psycho-educational support | Experimental | Behavioral: Psychological and psycho-educational support by phoneThe intervention group (IG) [that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process] |
| Control Group | Active comparator | Other: Brief counselling sessionThe control group (CG) [that will receive only a brief counselling session after discharge] |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- smokers;
- adults of both sexes ≥ 18 years to ≤76 years of age;
- that have stayed in an Acute or Detoxification mental health unit for more than 24 hours;
- with a telephone, fixed or mobile;
- residents in the metropolitan area of Barcelona;
Key exclusion criteria (9 listed)
- patient discharged from the psychiatric emergency room;
- with dementia or brain damage;
- that do not speak Spanish or Catalan;
- pregnant women;
- with hearing and/or speech deficit;
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 |
|---|---|---|
| Psychological and psycho-educational support by phoneAlso: Telephone-based motivational interventionThe intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011) | Behavioural | Psychological and psycho-educational support |
| Brief counselling sessionAlso: Brief adviceBrief counselling session | Other | Control Group |
Primary outcome
Change from tobacco consumption abstinence at 12 months
Time frame: through study completion, an average of 1 year
Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)
3 secondary outcomes
Change in the level of self-efficacy to quit smoking
Time frame: through study completion, an average of 1 year
Change of motivation to quit smoking (stage of change)
Time frame: through study completion, an average of 1 year
Attempts to quit smoking
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Background: PubMed 25462661Ballbe M, Martinez C, Salto E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernandez E. Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain. Addict Behav. 2015 Mar;42:136-9. doi: 10.1016/j.addbeh.2014.11.028. Epub 2014 Nov 26.
- Background: PubMed 21933940Ballbe M, Nieva G, Mondon S, Pinet C, Bruguera E, Salto E, Fernandez E, Gual A; Smoking and Mental Health Group. Smoke-free policies in psychiatric services: identification of unmet needs. Tob Control. 2012 Nov;21(6):549-54. doi: 10.1136/tobaccocontrol-2011-050029. Epub 2011 Sep 20.
- Background: PubMed 23543600Ballbe M, Sureda X, Martinez-Sanchez JM, Salto E, Gual A, Fernandez E. Second-hand smoke in mental healthcare settings: time to implement total smoke-free bans? Int J Epidemiol. 2013 Jun;42(3):886-93. doi: 10.1093/ije/dyt014. Epub 2013 Mar 29.
- Background: PubMed 25239470Ballbe M, Sureda X, Martinez-Sanchez JM, Fu M, Salto E, Gual A, Fernandez E. Secondhand smoke in psychiatric units: patient and staff misperceptions. Tob Control. 2015 Oct;24(e3):e212-20. doi: 10.1136/tobaccocontrol-2014-051585. Epub 2014 Sep 19.
- Background: PubMed 20491721Banham L, Gilbody S. Smoking cessation in severe mental illness: what works? Addiction. 2010 Jul;105(7):1176-89. doi: 10.1111/j.1360-0443.2010.02946.x. Epub 2010 May 11.
- Background: PubMed 16022945Chabrol H, Niezborala M, Chastan E, de Leon J. Comparison of the Heavy Smoking Index and of the Fagerstrom Test for Nicotine Dependence in a sample of 749 cigarette smokers. Addict Behav. 2005 Aug;30(7):1474-7. doi: 10.1016/j.addbeh.2005.02.001.
- Background: PubMed 21991895Fiore MC, Baker TB. Clinical practice. Treating smokers in the health care setting. N Engl J Med. 2011 Sep 29;365(13):1222-31. doi: 10.1056/NEJMcp1101512.
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Background: PubMed 12745503Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25.
- Background: PubMed 19473549Martinez C, Fu M, Martinez-Sanchez JM, Ballbe M, Puig M, Garcia M, Carabasa E, Salto E, Fernandez E. Tobacco control policies in hospitals before and after the implementation of a national smoking ban in Catalonia, Spain. BMC Public Health. 2009 May 28;9:160. doi: 10.1186/1471-2458-9-160.
- Background: PubMed 25218064Martinez C, Guydish J, Le T, Tajima B, Passalacqua E. Predictors of quit attempts among smokers enrolled in substance abuse treatment. Addict Behav. 2015 Jan;40:1-6. doi: 10.1016/j.addbeh.2014.08.005. Epub 2014 Aug 27.
- Background: PubMed 21665792Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Cristina Martínez, RN,BA, PhD principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological and psycho-educational support by phone and Brief counselling session in people with Mental Disorder and Smoking Cessation, run by Institut Català d'Oncologia at 1 site in Spain.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 11 Oct 2021. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from tobacco consumption abstinence at 12 months (time frame: through study completion, an average of 1 year). 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 NCT03230955, which also lists 17 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 11 Oct 2021.