Individual behavioural counselling for smoking cessation

Tim Lancaster; Lindsay F Stead

doi:10.1002/14651858.CD001292.pub3

. 2017 Mar 31;2017(3):CD001292. doi: 10.1002/14651858.CD001292.pub3

Individual behavioural counselling for smoking cessation

Tim Lancaster ^1,^✉, Lindsay F Stead ²

Editor: Cochrane Tobacco Addiction Group

PMCID: PMC6464359 PMID: 28361496

Abstract

Background

Individual counselling from a smoking cessation specialist may help smokers to make a successful attempt to stop smoking.

Objectives

The review addresses the following hypotheses:

1. Individual counselling is more effective than no treatment or brief advice in promoting smoking cessation.  2. Individual counselling is more effective than self‐help materials in promoting smoking cessation.  3. A more intensive counselling intervention is more effective than a less intensive intervention.

Search methods

We searched the Cochrane Tobacco Addiction Group Specialized Register for studies with counsel* in any field in May 2016.

Selection criteria

Randomized or quasi‐randomized trials with at least one treatment arm consisting of face‐to‐face individual counselling from a healthcare worker not involved in routine clinical care. The outcome was smoking cessation at follow‐up at least six months after the start of counselling.

Data collection and analysis

Both authors extracted data in duplicate. We recorded characteristics of the intervention and the target population, method of randomization and completeness of follow‐up. We used the most rigorous definition of abstinence in each trial, and biochemically‐validated rates where available. In analysis, we assumed that participants lost to follow‐up continued to smoke. We expressed effects as a risk ratio (RR) for cessation. Where possible, we performed meta‐analysis using a fixed‐effect (Mantel‐Haenszel) model. We assessed the quality of evidence within each study using the Cochrane 'Risk of bias' tool and the GRADE approach.

Main results

We identified 49 trials with around 19,000 participants. Thirty‐three trials compared individual counselling to a minimal behavioural intervention. There was high‐quality evidence that individual counselling was more effective than a minimal contact control (brief advice, usual care, or provision of self‐help materials) when pharmacotherapy was not offered to any participants (RR 1.57, 95% confidence interval (CI) 1.40 to 1.77; 27 studies, 11,100 participants; I² = 50%). There was moderate‐quality evidence (downgraded due to imprecision) of a benefit of counselling when all participants received pharmacotherapy (nicotine replacement therapy) (RR 1.24, 95% CI 1.01 to 1.51; 6 studies, 2662 participants; I² = 0%). There was moderate‐quality evidence (downgraded due to imprecision) for a small benefit of more intensive counselling compared to brief counselling (RR 1.29, 95% CI 1.09 to 1.53; 11 studies, 2920 participants; I² = 48%). None of the five other trials that compared different counselling models of similar intensity detected significant differences.

Authors' conclusions

There is high‐quality evidence that individually‐delivered smoking cessation counselling can assist smokers to quit. There is moderate‐quality evidence of a smaller relative benefit when counselling is used in addition to pharmacotherapy, and of more intensive counselling compared to a brief counselling intervention.

Plain language summary

Does individually‐delivered counselling help people to stop smoking?

Background

Individual counselling is commonly used to help people who are trying to quit smoking. The review looked at trials of counselling by a trained therapist providing one or more face‐to‐face sessions, separate from medical care. The outcome was being a non smoker at least six months later.

Study characteristics

We searched for trials in May 2016 and identified 49 trials Inlcuding around 19,000 participants. All the trials involved one or more face‐to‐face counselling sessions lasting at least 10 minutes, but most were much longer. Many also included further telephone contact for additional support. Thirty‐three of the trials compared individual counselling to a control group that only had minimal support, which could be usual care, brief advice about stopping smoking, or written materials. Of these, 27 did not offer any medication such as nicotine replacement therapy (NRT), which also helps people stop. Six of the 33 provided NRT or other medication to everyone in the trial. Twelve studies compared more intensive to less intensive counselling, and five compared different types of counselling.

Results and quality of evidence

Combining the results of the studies showed that having individual counselling could increase the chance of quitting by between 40% and 80%, compared to minimal support. This means that if seven out of 100 smokers managed to quit for at least six months using the sort of brief support given to the control groups, then between 10 and 12 in 100 would be expected to be successful after having counselling. We judged the quality of this evidence to be high. If everyone also had NRT or other medication, and 11 in 100 could quit in the control group, between 11 and 16 in 100 would be expected to be successful with the addition of counselling. We assessed this evidence as being of moderate quality, because the size of benefit was less certain. Having more intensive counselling support, for example more sessions, probably helps more, but the additional benefit is likely to be small, and again was of moderate quality because the size of benefit was uncertain. The few studies that compared different types of counselling did not show any differences between them.

Summary of findings

Background

Psychological interventions to aid smoking cessation include self‐help materials, brief therapist‐delivered interventions such as advice from a physician or nurse, intensive counselling delivered on an individual basis or in a group, and combinations of these approaches. Previous reviews have shown a small but consistent effect of brief, therapist‐delivered interventions (Stead 2013a). The effect of self‐help interventions is less clear (Hartmann‐Boyce 2014). More intensive intervention in a group setting increases quit rates (Stead 2017).

In this review, we assess the effectiveness of more intensive counselling delivered by a smoking cessation counsellor to a person on a one‐to‐one basis. One problem in assessing the value of individual counselling is that of confounding with other interventions. For example, counselling delivered by a physician in the context of a clinical encounter may have different effects from that provided by a non‐clinical counsellor. One approach to this problem is to employ statistical modelling (logistic regression) to control for possible confounders, an approach used by the US Public Health Service in preparing clinical practice guidelines (AHCPR 1996; Fiore 2000; Fiore 2008). An alternative approach is to review only unconfounded interventions. This is the approach we have adopted in the Cochrane Tobacco Addiction Review Group. We therefore specifically exclude from this review counselling provided by doctors or nurses during the routine clinical care of the patient, and focus on smoking cessation counselling delivered by specialist counsellors. We define counselling broadly, based only on a minimum time spent in contact with the smoker, not according to the use of any specific behavioural approach.

Objectives

The review addresses the following hypotheses:

Methods

Criteria for considering studies for this review

Types of studies

Randomized or quasi‐randomized controlled trials (RCTs) with a minimum follow‐up of six months, where at least one treatment arm consisted of an unconfounded intervention from a counsellor. Studies in which the treatment arm combined counselling and pharmacotherapy, and the control condition had neither, are covered in a separate review (Stead 2016).

Types of participants

Any smokers, except pregnant women (smoking cessation interventions in pregnancy are addressed by a separate review, Chamberlain 2013). We also exclude trials recruiting only children and adolescents.

Types of interventions

We defined individual counselling as a face‐to‐face encounter between a smoker and a counsellor trained in assisting smoking cessation. This review specifically excludes studies of counselling delivered by doctors and nurses as part of clinical care, which are covered in separate reviews (Rice 2013; Stead 2013a). It also excludes studies of interventions that combined counselling with provision of pharmacotherapy, compared to brief support (Stead 2016), studies of motivational interviewing (Lindson‐Hawley 2015) and interventions which address multiple risk factors in addition to smoking. We include studies that evaluate the effect of counselling as an addition to pharmacotherapy.

We include studies comparing different counselling approaches if they are not covered by other Cochrane Reviews of specific interventions. Comparisons between individual counselling and behavioural therapy conducted in groups are covered in the Cochrane Review of group behavioural therapy (Stead 2017).

Types of outcome measures

The outcome was smoking cessation at the longest reported follow‐up. We used sustained abstinence where available, or multiple point prevalence. We included studies using self‐report with or without biochemically‐validated cessation, and performed sensitivity analyses to determine whether the estimates differed significantly in studies without verification.

Search methods for identification of studies

We searched the Cochrane Tobacco Addiction Group Specialized Register for studies with counsel* in title, abstract or keyword fields. At the time of the search the Register included the results of searches of the Cochrane Central Register of Controlled trials (CENTRAL), issue 4, 2016; MEDLINE (via OVID) to update 20160513; EMBASE (via OVID) to week 201621; PsycINFO (via OVID) to update 20160516. See the Tobacco Addiction Group Module in the Cochrane Library for full search strategies and list of other resources searched. We also checked previous reviews and meta‐analyses for relevant studies, including all studies in the previous US guidelines (AHCPR 1996; Fiore 2000; Fiore 2008). The most recent search was conducted in May 2016.

Data collection and analysis

One author (LS, who is also the Cochrane Information Specialist for the Tobacco Addiction Group) prescreened results of the searches. Both authors checked reports of studies of potentially relevant interventions.

Both authors extracted data independently.

Information extracted included descriptive details on the setting of the study, the population, and details of intervention(s) and control conditions, including number and duration of planned sessions.

Assessment of risk of bias in included studies

We assessed risk of selection, detection and attrition bias, based on the reported methods of randomization and allocation concealment (selection bias), use of biochemical validation of self‐reported abstinence (detection bias) and numbers lost to follow‐up (attrition bias).

Measures of treatment effect & data synthesis

We summarized individual study results as a risk ratio (RR), calculated as: (number of quitters in intervention group/number randomized to intervention group) / (number of quitters in control group/number randomized to control group). We assumed that participants lost to follow‐up continued to smoke and included them as such in denominators. Where appropriate we performed meta‐analysis using a Mantel‐Haenszel fixed‐effect method to estimate a pooled risk ratio with a 95% confidence interval (CI) (Greenland 1985). We estimated the amount of statistical heterogeneity between trials using the I² statistic (Higgins 2003). Values over 50% can be regarded as moderate heterogeneity, and values over 75% as high.

We made the following comparisons:

Individual counselling versus no treatment, brief advice or self‐help materials
More intensive versus less intensive individual counselling
Comparisons between counselling methods matched for contact time

Results

Description of studies

We include 49 studies in this updated review, with around 19,000 participants. Thirty‐three studies (11 new for this update) contribute to the primary analysis comparing individual counselling to a minimal contact behavioural intervention. Eleven studies (six new) compared different intensities of counselling and five (two new) compared different counselling approaches which were similar in intensity of contact.

In a few cases we resolved difficulties in applying the inclusion criteria by discussion. In two cases (Wiggers 2006; Aveyard 2007) we were uncertain whether the providers were acting as specialist counsellors or were providing interventions as part of usual care in other healthcare roles. We included both after discussion about this aspect of their designs. We included one study that had only five months follow‐up (Kim 2005).

Study populations

Nineteen of the 49 studies recruited medical or surgical hospital inpatients (Pederson 1991; Ockene 1992; Stevens 1993; Rigotti 1997; Simon 1997; Dornelas 2000; Molyneux 2003; Simon 2003; Hennrikus 2005; Pedersen 2005; Brunner 2012), or outpatients (Weissfeld 1991; Kim 2005; Tonnesen 2006; Hennrikus 2010; Chan 2012; Ramon 2013; Thankappan 2013; Chen 2014). One recruited some inpatients (Schmitz 1999). Four other studies recruited drug‐ and alcohol‐dependent veterans attending residential rehabilitation (Bobo 1998; Burling 1991; Burling 2001; Mueller 2012). One study recruited new mothers in maternity wards (Hannover 2009); we considered the subgroup of trial participants who were smoking at this point. Other studies recruited smokers in primary care clinics (Fiore 2004; Aveyard 2007; Marley 2014; Ramos 2010), dental clinics (Nohlert 2009), primary care and local community (Aleixandre 1998), local community and university (Alterman 2001), communities and worksites (Nakamura 2004), at a periodic healthcare examination (Bronson 1989), at a Planned Parenthood clinic (Glasgow 2000), employees volunteering for a company smoking cessation programme (Windsor 1988), participants in a lung cancer screening study (Marshall 2016), and community volunteers (Jorenby 1995; Lifrak 1997; Ahluwalia 2006; Killen 2008; McCarthy 2008, Wu 2009; Garvey 2012; Kim 2015). Lack of interest in quitting was not an explicit exclusion criterion in any study, but the level of motivation to quit smoking was sometimes difficult to assess. One trial enrolled all smokers admitted to hospital (Stevens 1993), whilst one enrolled 90% of smokers approached (Rigotti 1997). In one large study in primary care 68% of smokers agreed to participate and 52% met the inclusion criteria and were recruited (Fiore 2004). In other studies a larger proportion of eligible smokers may have declined randomization because of lack of interest in quitting.

Special populations included Australian Aboriginal people (Marley 2014), homeless people (Okuyemi 2013), people under community corrections supervision (Cropsey 2015) and people with schizophrenia (Williams 2010). Two studies recruited Asian minority populations in the US; Kim 2015 (Koreans) and Wu 2009 (Chinese), and one recruited African Americans (Ahluwalia 2006).

Two studies recruited only women: Schmitz 1999 recruited 53 women hospitalized with coronary artery disease (CAD) and 107 volunteers with CAD risk factors. Glasgow 2000 recruited women attending Planned Parenthood clinics, who were not selected for motivation to quit. Weissfeld 1991 recruited only men, while Simon 2003 and Nakamura 2004 recruited predominantly men.

Thirty studies were conducted in the USA, three in Spain (Aleixandre 1998; Ramos 2010; Ramon 2013), three in Denmark (Pedersen 2005; Tonnesen 2006; Brunner 2012), two in the UK (Molyneux 2003; Aveyard 2007), two in Australia (Marley 2014; Marshall 2016), and one each in Germany (Hannover 2009), Switzerland (Mueller 2012), Sweden (Nohlert 2009), Netherlands (Wiggers 2006), Hong Kong (Chan 2012), China (Chen 2014), Japan (Nakamura 2004), Korea (Kim 2005), and India (Thankappan 2013).

Intervention components

The counselling interventions typically included the following components: review of a participant's smoking history and motivation to quit, help in the identification of high‐risk situations, and the generation of problem‐solving strategies to deal with such situations. Counsellors may also have provided non‐specific support and encouragement. Some studies provided additional components such as written materials, video or audiotapes. The main components used in each study are shown in the Characteristics of included studies tables.

Intervention providers

The therapists who provided the counselling were generally described as smoking cessation counsellors. Their professional backgrounds included social work, psychology, psychiatry, health education and nursing. In one study, the therapist for some of the sessions was a nurse practitioner (Alterman 2001), and in two others the therapists were research doctors or nurses trained in counselling (Molyneux 2003; Hennrikus 2005). In Aveyard 2007 all the support was from primary care nurses who were not full‐time counsellors. We included this study because the nurses were trained to provide counselling support as part of the National Health Service Stop Smoking Services and were not offering it as part of usual care. In Tonnesen 2006 the counselling was provided by nurses employed in a lung clinic, and in Wiggers 2006 it was provided by nurse practitioners in a cardiology outpatient clinic.

Studies with minimal contact controls

In the 33 studies with a minimal contact control the treatments offered to the control comparison group ranged from usual care to up to 15 minutes of advice, with or without the provision of self‐help materials. To be classified as individual counselling the trials had to involve at least one session with face‐to‐face contact lasting more than 10 minutes, although the duration was typically much longer. The face‐to‐face counselling in Kim 2005 was the shortest, at only 11 minutes on average. Three tested a single face‐to‐face session without further support by telephone (Weissfeld 1991 (low‐intensity arm); Molyneux 2003; Marshall 2016). Nine others offered a single face‐to‐face session with further support by telephone (Windsor 1988; Weissfeld 1991 (high‐intensity arm); Stevens 1993; Rigotti 1997; Simon 1997; Dornelas 2000; Glasgow 2000; Hennrikus 2005; Kim 2005). All the other studies planned multiple sessions of face‐to‐face support, and sometimes also telephone contacts.

In the meta‐analysis we have not distinguished between brief advice, usual care or provision of self‐help materials as the control intervention with which counselling is compared. Provision of written materials was generally accompanied by brief advice; no trials directly addressed the effect of providing counselling as an addition to a structured self‐help programme. One trial offered 15 minutes of counselling on a healthy diet to controls (Chan 2012), and one offered autogenic training, a relaxation‐based programme not shown to aid cessation (Mueller 2012).

Within this group of studies, pharmacotherapy was systematically provided to participants in all trial arms in six trials. Nicotine patch was provided to all participants in Jorenby 1995; Simon 2003; Fiore 2004; Okuyemi 2013. Cropsey 2015 provided bupropion to all participants. Wiggers 2006 provided nicotine patches to participants ready to quit in either trial arm. Since the use of pharmacotherapy might change the relative effect of additional counselling, we include these studies in a subgroup analysis. In one trial (Simon 1997) smokers randomized to receive counselling were given a prescription for nicotine gum if there were no contraindications. Although 65% in the counselling condition used gum compared to 17% of the control group, its use was not significantly associated with quitting.

Studies of counselling intensity

Eleven studies compared intensive counselling to less intensive interventions that also met our definition of counselling by involving more than 10 minutes of face‐to‐face contact. We considered these studies separately from those using a minimal‐contact control. Eight of these studies provided pharmacotherapy to all participants and we included subgroups for studies with and without pharmacotherapy. Tonnesen 2006 contributed to both subgroups.

Weissfeld 1991 compared two intensities of counselling with a control; both intensities are combined versus control in the first analysis but compared in this analysis.
Lifrak 1997 compared two intensities of counselling as an adjunct to nicotine patch therapy. The lower‐intensity one was a four‐session advice and education intervention from a nurse practitioner who reviewed self‐help materials and monitored patch use. The higher‐intensity intervention added 16 weekly sessions of cognitive behavioural relapse prevention therapy.
Alterman 2001 used similar interventions to Lifrak 1997, but added a lower‐intensity control of a single 30‐minute session with a nurse practitioner.
Tonnesen 2006 compared seven visits and five phone calls with a contact time of 4½ hours to four visits and six calls taking 2½ hours. This trial had a factorial design, also comparing a nicotine sublingual tablet and placebo; we entered the arms with and without NRT in separate subgroups.
Aveyard 2007 compared seven weekly contacts with four contacts for people receiving cessation support with nicotine patches.
Killen 2008 provided six counselling session and combined NRT and bupropion, and compared different schedules of extended contact.
Nohlert 2009 compared eight 40‐minute sessions over four months with a single 30‐minute session introducing a self‐help programme.
Wu 2009 compared four 60‐minute culturally‐tailored counselling sessions to four 60‐minute health education sessions covering general health, nutrition, exercise and tobacco. All sessions were in Chinese, and all participants were offered nicotine patch.
Williams 2010 compared 24 weekly 45‐minute counselling sessions to nine 20‐minute sessions that focused on medication management. All participants were given nicotine patches.
Brunner 2012 provided a 30‐minute counselling session and offer of nicotine patch during a hospital stay and tested the effect of an additional five outpatient sessions including free samples of NRT; we included this in the non‐pharmacotherapy subgroup, as it was not provided as standard to all participants.
Kim 2015 compared eight weekly 40‐minute sessions of culturally‐tailored counselling to eight 10‐minute sessions focusing on medication management. All participants received nicotine patches.

Studies of counselling methods or timing

Five studies compared different counselling approaches that had similar contact times. We considered these separately from the groups above.

Schmitz 1999 involved six one‐hour sessions. One intervention used a coping skills relapse prevention model. It was compared with a health belief model that focused on smoking‐related health information, the relationship with coronary disease and the benefits of quitting.
Ahluwalia 2006 provided three face‐to‐face visits and three phone contacts extending over six weeks, and 2 mg nicotine gum for eight weeks. One intervention used motivational interviewing and the other a health education focus.
McCarthy 2008 provided eight 10‐minute counselling sessions during assessment visits in a trial that also compared bupropion to placebo. The counselling was consistent with US practice guidelines. The control focused on medication use and adherence, and general support and encouragement.
Garvey 2012 compared two different schedules of 14 counselling sessions, either front‐loaded with six sessions in the first two weeks after quit date, or just two in that period. All participants received nicotine patches.
Ramon 2013 directly compared delivery of counselling either entirely face‐to‐face or with a combination of face‐to‐face and telephone to a control group where all contact after the pre‐quit session was by telephone.

Excluded studies

We excluded one study that provided motivational interviewing as part of an intervention to reduce passive smoke exposure in households with young children (Emmons 2001). Cessation was a secondary outcome and there was no significant difference in quit rates, which were not reported separately by group. A sensitivity analysis including this study assuming equal quit rates did not alter the review results.

We list 48 other studies identified as potentially relevant but which did not meet the full inclusion criteria, with their reasons for exclusion in the table Characteristics of excluded studies. We note where studies were included in other Cochrane Reviews.

Risk of bias in included studies

We assessed the risks of selection bias, detection bias and attrition bias.

Twenty‐seven studies reported the method for generating the randomization sequence in sufficient detail to be classified as having a low risk of bias, but only 14 also described a method of allocation likely to ensure that the assignment was concealed until after allocation, and thus being at low risk of selection bias (Simon 1997; Weissfeld 1991; Windsor 1988; Kim 2005; Ahluwalia 2006; Wiggers 2006; Aveyard 2007; Killen 2008; McCarthy 2008; Williams 2010; Chan 2012; Ramon 2013; Marley 2014; Marshall 2016). In most other trials, neither the method of randomization nor the use of allocation concealment was described. We judged five trials to be at high risk of selection bias, due to the method of randomization or concealment, or both (Stevens 1993; Bobo 1998; Dornelas 2000; Hannover 2009; Brunner 2012).

We judged the risk of detection bias to be low if self‐reported abstinence was confirmed biochemically. Eight studies were at high risk of bias because no validation was attempted and trial arms had different amounts of contact with study staff, making differential misreporting of abstinence more likely (Bronson 1989; Stevens 1993; Aleixandre 1998; Pedersen 2005; Nohlert 2009; Thankappan 2013; Kim 2005; Ahluwalia 2006). We rated three studies as unclear; one study tested for cotinine but did not report validated rates (Bobo 1998), and in two others validation was incomplete and results were based on self‐report (Pederson 1991; Marshall 2016).

We judged the risk of attrition bias to be low if loss to follow‐up was reported by group, was no greater than 50% and not substantially different between groups. Most studies reported the number of participants who dropped out or were lost to follow‐up, and included these people as smokers in analysis denominators. We judged most studies to be at low risk of bias, because the percentage lost was small and similar across conditions. We classified two studies as being at high risk (Ramos 2010; Mueller 2012), and one as unclear (Burling 1991). One study (Fiore 2004) excluded randomized participants who failed to collect their free supply of nicotine patches, and as a consequence also did not receive any additional behavioural components to which they were allocated. The proportions excluded were similar in all the intervention groups, so we have used the denominators as given.

Overall we classified 11 of the 49 included studies (22%) as being at low risk of bias on all the domains we considered. A summary is displayed in Figure 1.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

We did not formally assess the risk of performance bias. There was little information about blinding of participants or staff during treatment. Whilst the therapists delivering counselling could not have been blinded, in some cases other care providers were noted to be unaware of intervention status. It was unclear what information participants were given, but almost all trials included an active control group that received some information about stopping smoking. Because of this, we do not consider that the risk of bias from this aspect of design for this group of studies is high.

Effects of interventions

See: Table 1; Table 2

Summary of findings for the main comparison. Individual counselling compared to minimal contact control for smoking cessation.

Patient or population: People who smoke  Setting: Healthcare and community settings  Intervention: Individual counselling from a smoking cessation counsellor including at least one face‐to‐face session lasting 10 minutes or more  Comparison: Minimal‐contact control (usual care, brief advice or self‐help materials)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Numbers quit in control condition	Numbers quit after individual counselling
Smoking cessation at longest follow‐up ‐ 6 months or more No systematic pharmacotherapy	Study population		RR 1.57  (1.40 to 1.77)	11,100  (27 RCTs)	⊕⊕⊕⊕  HIGH	Limiting to studies at low risk of bias on all assessed domains marginally increases estimate of effect
	7 per 100	11 per 100  (10 to 12)
Smoking cessation at longest follow‐up ‐ 6 months or more Pharmacotherapy offered to all participants	Study population		RR 1.24  (1.01 to 1.51)	2662  (6 RCTs)	⊕⊕⊕⊝  MODERATE ¹	Higher control group quit rate reflecting use of pharmacotherapy
	11 per 100	13 per 100  (11 to 16)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence  High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

More intensive compared to less intensive counselling for smoking cessation
Patient or population: People who smoke  Setting: Healthcare and community settings  Intervention: More intensive individual counselling (± pharmacotherapy)  Comparison: Individual counselling (± pharmacotherapy)
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Numbers quit with less intensive counselling	Numbers quit with more intensive counselling
Smoking cessation at longest follow‐up	Without pharmacotherapy		RR 1.29  (1.09 to 1.53)	2920  (11 RCTs)	⊕⊕⊕⊕  HIGH	Effect estimates for subgroups of studies with and without pharmacotherapy for all participants overlapped, so the overall pooled estimate is used with alternative control group estimates from subgroups
	9 per 100 ¹	12 per 100  (10 to 14)
	With pharmacotherapy
	14 per 100 ²	18 per 100  (15 to 21)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence  High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Date	Event	Description
23 November 2016	New citation required but conclusions have not changed	No change to main conclusions.
23 November 2016	New search has been performed	Searches updated, 19 new studies included. 'Summary of findings' table added.
16 July 2008	New search has been performed	Updated for 2008 issue 4 with nine new studies. No changes to conclusions
21 May 2008	Amended	Converted to new review format.
8 February 2005	New citation required but conclusions have not changed	Updated for 2005 Issue 2 with three new studies. No changes to conclusions.
7 April 2002	New citation required but conclusions have not changed	Updated for 2002 Issue 3 with six new studies. No changes to conclusions.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Smoking cessation at longest follow‐up	33	13762	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [1.34, 1.64]
1.1 Counselling versus control (no systematic pharmacotherapy)	27	11100	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.40, 1.77]
1.2 Counselling plus pharmacotherapy versus pharmacotherapy alone	6	2662	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [1.01, 1.51]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Smoking cessation at longest follow‐up	11	2920	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [1.09, 1.53]
1.1 No pharmacotherapy	4	872	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [0.98, 2.06]
1.2 Adjunct to pharmacotherapy	8	2048	Risk Ratio (M‐H, Fixed, 95% CI)	1.26 [1.04, 1.52]

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 Smoking cessation at longest follow‐up	5	Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
1.1 Relapse prevention versus health belief model	1	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Motivational interviewing versus health education	1	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 Counselling versus equal sessions of psychoeducation	1	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 Front‐loaded versus weekly counselling	1	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.5 Face‐to‐face versus telephone counselling	1	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Methods	Study design: Randomized controlled trial Setting: Community health centre, USA  Recruitment: community volunteers interested in quitting
Participants	755 African‐American light smokers (≤ 10 cpd)  67% women, av. age 45, av. cpd 8
Interventions	Therapists: trained counsellors Factorial trial, 2 mg nicotine gum/placebo arms collapsed for this review  1. Counselling using motivational interviewing (MI) approach. 3 in‐person visits at randomization, wk 1, wk 8, and phone contact at wk 3, wk 6, wk 16, S‐H materials  2. Counselling using health education (HE) approach. Same schedule and materials as 1
Outcomes	PP abstinence at 6m (7‐day PP)  Validation: cotinine ≤ 20 ng/ml
Notes	Not in main analysis; compares 2 counselling styles. No significant effect of gum, no evidence of interaction.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Centrally generated blocked scheme, block size 36
Allocation concealment (selection bias)	Low risk	Sealed envelopes opened sequentially
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Biochemical validation of abstinence planned, but low level of cotinine validation. All participants received same level of contact so risk of differential misreporting judged to be low
Incomplete outcome data (attrition bias)   All outcomes	Low risk	118 (15.6%) lost to follow‐up included in ITT analysis. HE participants less likely to be lost. Alternative assumptions about losses did not alter conclusions

Methods	Study design: Cluster‐randomized controlled trial Setting: 12 residential centres for alcohol/drug treatment, USA  Recruitment: inpatient volunteers
Participants	(50 participants in each of 12 sites)  67% men, av. age 33  50% smoked > 1 pack/day
Interventions	Therapists: centre staff for 1st session, trained counsellors for telephone sessions  1. 4 x 10 ‐ 15 min sessions. 1st during inpatient stay. 3 by telephone, 8, 12, 16 wks post‐discharge  2. No intervention
Outcomes	Abstinence at 12 m post‐discharge (7 day PP)  Validation: saliva cotinine, but validated quit rates not reported  (A primary outcome for the study was alcohol abstinence)
Notes	Cluster‐randomized, so individual data not used in primary meta‐analysis. Adjusted OR 1.02 (CI 0.50 to 2.49). Inclusion would not materially change results of analysis 1.1.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Matched pairs of centres allocated by coin toss, 2 centres declined participation after allocation
Allocation concealment (selection bias)	High risk	Cluster‐randomized with participant recruitment (by research team) after centre allocation so potential for selection bias
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Biochemical validation of abstinence but validated results not reported
Incomplete outcome data (attrition bias)   All outcomes	Low risk	22% lost to follow‐up. Including them as smokers made little difference to estimates

Methods	Study design: Randomied controlled trial Setting: Hospital, China Recruitment: community volunteers and referrals from outpatient clinics
Participants	190 smokers, > 1 cpd, 97% men, av.age 50, av. cpd 20. All had lung function tests; 85 had COPD and 105 were asymptomatic
Interventions	Therapist: "Interventions provided by 2 doctors with experience of professional smoking cessation treatment." 1. Cognitive counselling, 20 mins at baseline and 9 calls > 10 mins at 1 ‐ 4 wks, 6 wks, 8 wks, 3 ‐ 5 m. S‐H materials 2. Brief advice
Outcomes	Abstinence at 6 m sustained from week 4 Validation: CO < 10 ppm
Notes	New for 2016 update
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"assigned to the intervention or control group according to the randomized digital table" stratified by motivation to quit
Allocation concealment (selection bias)	Unclear risk	No further details
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Biochemical validation of abstinence
Incomplete outcome data (attrition bias)   All outcomes	Low risk	12 withdrawals included as smokers

Methods	Study design: Controlled trial Setting: 2 Health Maintenance Organization hospitals, USA  Recruitment: All hospitalized smokers or recent ex‐smokers with stay > 36 hrs
Participants	1119 smokers or recent quitters (5%)  av. age 44, av. cpd 20
Interventions	Therapists: Masters level cessation counsellors 1. 20‐min counselling session, 12‐min video, quit kit, choice of S‐H materials, 1 ‐ 2 follow‐up telephone calls, access to hotline, bimonthly newsletter mailings  2. Usual care
Outcomes	Abstinence at 12 m (2 PP, 3 and 12m)  Validation: due to low success in obtaining samples for cotinine analysis, data are based on self‐report only
Notes	We report a sensitivity analysis on the effect of exclusion of this non‐random study
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Not random, intervention alternated between hospitals on a monthly basis in order to avoid contamination
Allocation concealment (selection bias)	High risk	Intervention or control status of hospital known when participants recruited
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Self‐reported quitting only
Incomplete outcome data (attrition bias)   All outcomes	Low risk	6% loss to follow‐up, no difference by group, included in ITT analysis

Study	Reason for exclusion
Alonso‐Pérez 2007	Allocation to behavioural treatment was by clinic attended; each of 3 primary care clinics provided different treatment. Differences between outcomes could have been due to differences between patients in different clinics; no way to estimate effect of clustering
Berndt 2014	Face‐to‐face counselling confounded with provision of NRT, compared to usual care control. Comparison with telephone counselling confounded by different duration of treatment and therapists
Bock 2014	Main intervention component was motivational interviewing, see Lindson‐Hawley 2015
Bolman 2002	Intervention provided by a nurse as part of usual care, included in Cochrane Review of nursing interventions (Rice 2013)
Borrelli 2005	Intervention provided by a nurse during normal duties, included in Cochrane Review of nursing interventions (Rice 2013)
Calabro 2012	Multicomponent intervention included access to internet‐based resources and health feedback in addition to 2 counselling sessions, as adjunct to offer of NRT (see Stead 2015)
Camarelles 2002	Compares individual to group counselling, see Cochrane Review of group‐based interventions (Stead 2017)
Canga 2000	Intervention provided by a nurse, included in Cochrane Review of nursing interventions (Rice 2013)
Catley 2016	Participants were smokers not planning to quit. Currently listed as an ongoing study in Lindson‐Hawley 2015 'Motivational interviewing for smoking cessation' and will be included there
Clarke 2013	Short follow‐up (˜4.5 months from start of intervention, 3 months from prison discharge). Participants were abstinent whilst in prison
Colby 1998	Short follow‐up (3 months)
Dezee 2013	No brief‐advice control, comparison was with internet support
Emmons 2001	Data not available for intervention and control groups separately. No significant difference reported. Cessation was a secondary outcome in this trial using motivational interviewing to reduce passive smoke exposure. Participants were not selected by motivation to quit
Froelicher 2004	Intervention provided by a nurse; included in Cochrane Review of nursing interventions (Rice 2013)
Gariti 2009	Control group had multiple sessions for 'medication management'. Included in Stead 2015
Ghanem 2014	Unpublished study. Insufficient detail in either abstract to include or to enable contact with author for further information
Gifford 2004	Trial of an acceptance and commitment‐based treatment intervention that included multiple group sessions in addition to individual counselling. Comparator was nicotine patch therapy
Gifford 2011	Trial of an acceptance and commitment‐based treatment intervention that included multiple group sessions in addition to individual counselling as adjunct to bupropion
Gorini 2012	Counselling intervention was brief advice provided by midwives conducting PAP test, not by dedicated cessation counsellors
Harris 2010	Participants included smokers not planning to quit. See Lindson‐Hawley 2015
Hilberink 2005	Intervention provided by physicians and nurses in usual care setting, not specialist counselling
Hokanson 2006	Participants included smokers not planning to quit, and recent quitters. See Lindson‐Hawley 2015
Hyman 2007	Multiple risk factor intervention
Kadowaki 2000	Intervention was multicomponent and included advice/counselling from a physician, nurse and a group programme. Follow‐up only 5 months
Lando 1992	There was no face‐to‐face contact with counsellors. Contact was by proactive telephone calls
Lloyd‐Richardson 2009	Compared motivational interviewing to less intensive counselling, as adjuncts to nicotine patch, see Lindson‐Hawley 2015
Lopez 2007	Multiple risk factor intervention enrolling smokers and nonsmokers
Malchodi 2003	Intervention specifically for pregnant women, see Cochrane Review of smoking cessation interventions in pregnancy (Chamberlain 2013)
Marks 2002	Intervention was provided in a self‐help format
McCarthy 2016	All participants received counselling, intervention was a 'practice quitting' programme
Mildestvedt 2007	Multiple risk factor lifestyle intervention
Mooney 2007	Short follow‐up (6 wks). Study added a pharmacotherapy compliance‐enhancing component to individual counselling using CBT
Niaura 1999	All participants received individual counselling; Included in Cochrane NRT review (Stead 2008)
Okuyemi 2006	Intervention combined group and individual counselling with pharmacotherapy
Rabkin 1984	The health education arm of the trial included a group meeting with didactic lecture, film and discussion, followed by a single individual session with a therapist. We decided that this did not meet the criteria for individual counselling
Raja 2014	Short‐term study, outcome was nicotine dependence
Rodriguez 2003	Intervention combined the systematic use of NRT with counselling; covered in Cochrane Review of worksite interventions (Cahill 2014)
Sanz‐Pozo 2006	Intervention provided by nurses in a primary care clinic, included in Cochrane Review of nursing interventions (Rice 2013)
Savant 2013	Not restricted to smokers; more than half of participants used chewing tobacco. Cessation rates not given by type of tobacco use
Schnoll 2005	Short follow‐up (3 months). Compared 2 counselling approaches, no difference detected
Schwartz 1967	Success was defined as reduction in smoking of over 85%, not complete abstinence
Secades‐Villa 2009	Cluster‐randomised by primary care centre with 1 centre per condition; no way to allow for intra‐cluster correlation
Sherman 2007	Primary outcome was not cessation; assessed rates of receiving counselling, referral and treatment
Soria 2006	Motivational interviewing intervention by primary care physician during routine care
Stein 2006	Test of motivational interviewing; not all participants attempted to quit
Stevens 2000	Intervention providers were respiratory therapists, not counsellors. Included in Cochrane Review of interventions in hospital inpatients, (Rigotti 2012)
Williams 2006	Study targeted multiple risk factors
Wittchen 2011	Counselling was delivered by non‐specialist physicians
Woodruff 2002	Short follow‐up (3 months)

Trial name or title	Call it Quits
Methods	Block‐randomized controlled trial
Participants	Socially disadvantaged population, target n = 400
Interventions	The smoking cessation (intervention) group will receive an intensive participant‐centred smoking cessation intervention offered by the caseworker over a minimum of 3 face‐to‐face visits (each 2 weeks apart) which will begin immediately following baseline survey completion, followed by at least 2 phone contacts (1 week apart). This intervention will constitute an add‐on to participants' usual regular counselling visits, reducing additional costs to the Centre and to participants. If a participant requires further contact, staff will provide further quitting assistance and record what they delivered on their checklist. The control group will receive minimum ethical care.
Outcomes	2 primary outcome measures obtained at 1‐, 6‐, and 12‐month follow‐up:   1) 24‐hour expired air CO‐validated self‐reported smoking cessation; and   2) 7‐day self‐reported smoking cessation.   Continuous abstinence will also be measured at 6‐ and 12‐month follow‐up
Starting date	01/02/2010
Contact information	billie.bonevski@newcastle.edu.au; Faculty of Health and Medicine, Centre for Translational Neuroscience and Mental Health, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia
Notes

Trial name or title	Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Methods	Randomized trial
Participants	450 daily smokers
Interventions	Participants are randomized to 1 of 3 behavioural treatments:   (1) Brief Duration (3‐month) smoking‐cessation counselling;   (2) Moderate Duration (6‐month) counselling; or   (3) Extended Duration (12 month) counselling
Outcomes	Primary: abstinence at 1 year. Secondary; abstinence at 2 years
Starting date	2008
Contact information	Arthur J. Garvey, Ph.D., Harvard School of Dental Medicine
Notes

PERMALINK

Individual behavioural counselling for smoking cessation

Tim Lancaster

Lindsay F Stead

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Data collection and analysis

Assessment of risk of bias in included studies

Measures of treatment effect & data synthesis

Results

Description of studies

Study populations

Intervention components

Intervention providers

Studies with minimal contact controls

Studies of counselling intensity

Studies of counselling methods or timing

Excluded studies

Risk of bias in included studies

1.

Effects of interventions

Summary of findings for the main comparison. Individual counselling compared to minimal contact control for smoking cessation.

Summary of findings 2. More intensive compared to less intensive counselling for smoking cessation.

Counselling versus minimal contact control

1.1. Analysis.

2.

More intensive versus less intensive counselling

2.1. Analysis.

Comparisons between counselling approaches

Discussion

Authors' conclusions

Implications for practice.

Implications for research.

What's new

History

Acknowledgements

Data and analyses

Comparison 1. Individual counselling compared to minimal contact control.

Comparison 2. More intensive versus less intensive counselling.

Comparison 3. Comparisons between counselling approaches of similar intensity.

3.1. Analysis.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ahluwalia 2006.

Aleixandre 1998.

Alterman 2001.

Aveyard 2007.

Bobo 1998.

Bronson 1989.

Brunner 2012.

Burling 1991.

Burling 2001.

Chan 2012.

Chen 2014.

Cropsey 2015.

Dornelas 2000.

Fiore 2004.

Garvey 2012.

Glasgow 2000.

Hannover 2009.

Hennrikus 2005.

Hennrikus 2010.

Jorenby 1995.