PROTOCOL: Cognitive‐Behavioural Therapies for Young People in Outpatient Treatment for Non‐Opioid Drug Use

Abstract

Youth drug use1 that persists beyond curious experimentation is a severe problem worldwide (United Nations Office of Drugs and Crime [UNODC], 2010). Drugs such as cannabis, amphetamines, ecstasy, and cocaine, referred to in this review as non-opioids2 are widely available and used among young people in western countries (European Monitoring Centre for Drugs and Drug Addition [EMCDDA], 2010; Substance Abuse and Mental Health Services Administration [SAMHSA], 2010). Non-opiates such as amphetamines, cocaine, ecstasy and cannabis, characterized by young peopleas social drugs, are often taken in recreational settings such as dance clubs and music events. For young people these non-opiates are often associated with “pleasure” and experimental drug taking (Østergaard & Bastholm Andrade, 2011; Järvinen & Ravn, 2011). However non-opioid drug use, like other drugs, is strongly associated with a range of health and social problems including delinquency, poor scholastic attainment, and suicide (Deas & Thomas, 2001; Essau, 2006; Rowe & Liddle, 2006; Shelton, Taylor, Bonner & van den Bree, 2009). The 2009 US National Survey on Drug Use estimated that 21.8 million (8.7 percent) people in the US aged 12 or older have used drugs during the past month. The most commonly used drug was marijuana. In 2009, 16.7 million people aged 12 or older (6.6 percent) used this drug. In the same year, 1.6 million people aged 12 or older (0.7 percent) used cocaine, 760,000 (0.3 percent) used ecstasy and 502,000 (0.2 percent) used methamphetamine. The highest rate of drug use in the US was found among persons aged 18 to 20. In this age group 22.2 per cent used drugs, while the rate was10 per cent among 12 to 17 year olds (SAMHSA, 2010)3. The European Monitoring Report estimated that 19.5 million (30.9 percent)of Europeans aged 15-24 years used cannabis at some point in their life with the highest prevalence in the Czech Republic, France, Denmark and Germany (EMCDDA, 2010). Within the month preceding the survey,5.5 million (8.4 per cent) young people in Europe aged 15-24 years had used cannabis. Synthetic drugs were the second most used drug (EMCDDA, 2010). In 2009 2.5 million (1.7 percent) European 15-34 year-olds used ecstasy, 1.5 million (1.2 percent) used amphetamines, and 3 million (2.3 per cent) used cocaine (EMCDDA, 2010). Non-opioid substances are associated with varying patterns of behaviour and the potential for addiction (Rawson & Ling, 2008; Weaver & Schnoll, 2008; Kosten, Sofuoglu & Gardner, 2008). While for some young people drug use is controlled and part of developmental experimentation that will not constitute a clinical problem, a proportion of these users will advance to more serious levels of drug usethat at some point in the future requires treatment (Yamaguchi & Kandel, 1984; Shelder & Block, 1990; Labouvie & White, 2002; Järvinen & Ravn, 2011). Drug use is connected to three aspects: 1) individual characteristics, 2) the interaction between the individual and their environment and 3) certain stimulus gained from the drug use (Nielsen & Thomsen, 2005; Carroll, 2008). The treatment needs of young people differ from those of adults because of their special stage of psychological and physical development, and therefore researchers advocate distinct interventions for this population (Holmbeck, O'Mahar, Abad, Colder & Updegrove, 2006; Knudsen, 2009). Kendall (2006) argues that it is not enough to encourage young people to gain insight into their drug taking and ask them to consider changes to address their sometimes problematic drug use without providing them with opportunities to practice new coping skills aimed to compensate for cognitive limitations and distortions closely linked to their developmental stage. Other researchers concur with the need for practice-oriented and targeted treatment interventions that are developmentally appropriate for this population (Weisz & Hawley, 2002;Holmbecket.al., 2006, Shirk & Karver, 2006). Cognitive-Behavioural Therapy (CBT) interventions include a variety of such practical elements. As a structured yet flexible, individualized and multi component intervention, CBT is adaptable and tailored to deal with the challenges associated with specific substances and young people's individual needs. The focus of this review is on young people enrolled in treatment for drug use, independent of how their problems are labelled. Enrolment in treatment denotes that the degree of the young person's drugs use has caused the young person or a significant other close to them (parent, teacher, social worker, etc.,) to require treatment. This review will focus on CBT delivered as an outpatient treatment4and to avoid duplication of effort this review will focus primarily on non-opioid drug use5. In CBT interventions drug use is perceived as a complex, multi-determined cognitive and behavioural pattern influenced by several domains including family history, environmental genetic factors, and comorbid psychopathologies that all play a contributing role in the development of and/or perpetuation of drug use (Carroll, 2008). The primary focus of CBT is on reducing users' positive expectations about druguse, enhancing their self-confidence to resist drugs, and improving their problem solving skills and skills for coping with daily life stressors (Moos, 2007; Kaminer, Burleson, Blitz, Sussman, & Rounsaville, 1998). CBT aims to address the learned association between drug-related cues or stimuli and drug use by understanding and changing undesirable cognitive and behaviour patterns (Carroll, 2008; Shirk & Karver, 2006).CBT combines behavioural and cognitive therapy. While behavioural therapy mainly focuses on external settings and observable behaviour, cognitive therapy is concerned with internal cognitive processes. Behavioural therapy was developed from the ideas of classical and operant conditioning (Poulsen, 2006, McGuire, 2000). In classical conditioning, behaviour is believed to be affected by stimulus-response mechanisms in the immediate surroundings of the individual; for instance, urges and cravings for drugs can be perceived as responses to external stimuli cues (Sherman, Jorenby & Baker, 1988). Identifying external stimuli cues would enable the individual to avoid settings that work as triggers to drug taking (Carroll, 2008). Operant conditioning is based on associations within a context of events (e.g.,an antecedent stimulus) and a given behaviour and its consequences, whereby perceived rewards can (negatively or positively) reinforce such behaviour (Skinner, 1988). For example, negative reinforcement is when peers do not condone drug use and positive reinforcementis for example when the psychological effect of a drug is experienced as pleasurable (Waldron & Kaminer, 2004). In a treatment context non-drug using behaviour is rewarded and thus reinforced. The assumption in cognitive therapy is that thoughts shape feelings and thereby, behaviour, so that it is hypothesized that by changing thought patterns, behaviour can be changed as well (Beck, Wright, Newman, & Liese 1993; Kendal l 2006; Nielsen & Thomsen, 2005). In the early 1960s cognitive therapy was aimed at treating depression, and has since been extensively modified and adapted to deal with a wide range of clinical problems and populations including people with drug use issues (Beck, 2008; Holmbeck et al., 2006; Weisz & Hawley, 2002). The foundation and premise of CBT for drug use is that cognitive techniques and skills training can tackle drug-related beliefs and automatic thoughts that lead to urges and craving, while additional behavioural techniques can deal with actions that interact with the individual's cognitive processes that trigger and maintain drug using behaviour (Beck et al., 1993). Irrational and erroneous assumptions can cause and/or maintain undesirable behaviour (ibid.). CBT callsspecific attention to the propensity among substance users to mistakenly believe that the perceived advantages of using drugs (e.g., pleasure, anxiety relief) are greater than the disadvantages (e.g., financial, interpersonal) as such misconceptions help sustain the avoidance of a realistic assessment of the disadvantages (ibid.; Carroll, 2008; Nielsen & Thomsen, 2005). Thus, it is believed that the users' assessment of the possibilities for ceasing to use drugs might be based on cognitive distortions. In CBT, clients are helped to identify and challenge dysfunctional beliefs (such as ‘I cannot be happy unless I am using’ or ‘the withdrawal will be too painful‘), because thinking that one is incapable of controlling the urge to use drugs will create a self-fulfilling prophecy, as users who believe they are incapable will not even try (Beck et al., 1993). The common denominator in all CBT interventions is to make and support continuous positive change in the client's feelings and behaviour by examining and reframing the basic maladaptive assumptions and thoughts underlying drug use (Beck, 2008; Carroll, 2008, Moos, 2007; McGuire, 2000). CBT outlines a pattern and series of phases of drug use from the first stimulating cue to the actual act of drug using that is specific to the client. The activating stimulus can be both external (e.g., a gathering of friends using cocaine) or internal (e.g., anxiety or boredom) (Beck et.al., 1993; Beck, 2008; McGuire, 2000; Nielsen & Thomsen, 2005; Carroll, 2008). These stimuli can trigger basic assumptions (e.g., ‘I am socially isolated’) that trigger automatic thoughts (e.g. ‘A little cocaine will make me feel better’), which in turn trigger cravings and permissive beliefs that make it easier for the person to engage in the behaviour (e.g., ‘It is okay as long as I don't inject’). The individual would then form a mental strategy for obtaining the drugs and the actual drug using act could then take place. CBT would tackle this pattern of drug use by enlisting a number of techniques and strategies. Through problem solving, coping strategies, rehearsal, social skills and communication training, as well as helping young people to respond to criticism and refusing drugs, the therapist can help the young person to identify stimulating cues, discuss how to cope, and avoid drug taking behaviour. However, some stimulating cues (e.g., emotional states) may be unavoidable and consequently modifying maladaptive beliefs and automatic thought patterns that maintain drug using behaviour would be equally important (Beck et al., 1993; Beck, 2008; McGuire, 2000) CBT interventions couldincludepermutations of various components such as thought diaries, social skills training, problem solving strategies, coping strategies, self-control and stress management techniques, and relapse prevention training. CBT has different modalities and can be implemented in an individual and/or group setting (Moos, 2007). CBT is a highly structured intervention and is organised closely around well-specified and individualized treatment goals (Carroll, 2008). Each CBT session is structured by an articulated agenda and discussions remain focused around issues directly related to substance use. In some cases, the therapist may lead thetherapy session with ‘motivational interviews‘6 (Carroll, 2008; Nielsen & Thomsen, 2005). To exemplify:a therapy session typically (but not invariably)includes the following three parts: First, aclient's substance use and general functioning would be assessed (and would vary according to degree of dependency and individual conditions). A specific cognitive technique that can help identify and modify drug-related beliefs is an'advantages-disadvantages' analysis (Beck et al.,1993). In this analysis, the therapist guides the client through the process of listing and re-evaluating the advantages and disadvantages of drug use to help the young person gain a more accurate, objective and balanced view of drug use. The second part of the therapy session is typically didactic in structure and devoted to skills training, coping and problem-solving strategies and practice. One technique for examining beliefs and considering their validity in a more systematic way is ‘The Daily Thought Record‘. Clients are asked to record their thoughts and feelings and then re-evaluate their validity, identify possible patterns of cognitive distortions and develop strategies for change (Beck et al., 1993, Nielsen & Thomsen, 2005; Carroll, 2008). The therapist may also encourage the client to try new behaviours through role playing, for the purpose of teaching the client new effective interpersonal skills, e.g., how to handle interpersonal conflicts without drug taking and develop effective repertoires of social behaviour to reduce undesirable drug use and deal with relapse if it occurs (Beck et al., 1993; Kaminer & Waldron, 2006). Finally, the third part of the therapy session is usually dedicated to plan for the week ahead and discuss how new skills and strategies could be implemented (Carroll, 2008). This kind of collaborative empiricism that characterises CBT is particularly important when dealing with young substance users, to assist them in learning self-regulation and to exert self-control. However this kind of collaboration may also be a point of concern for the intervention's effectiveness, as participation in CBT demands a certain (above average) level of verbal articulation and self-awareness (Nielsen & Thomsen, 2005). CBT interventions can range from 5 to 24 weeks in duration and delivery settings can vary from outpatientto community facilities, and can be delivered to individuals, groups, families and a combination of these (Dennis et al., 2004; Carroll, 2008). Purely behavioural (e.g., a standalone contingency intervention) will not be considered in this review. Along with a handful of other interventions, CBT is one of the most researched treatment forms (Becker & Curry, 2008; Carroll, 2008).CBT has shown promising potential for young drug users in the number of primary studies (Kaminer et. al., 1998; Kaminer & Burleson, 1999;Waldron, Slesnick, Brody, Peterson, & Turner, 2001; Kaminer, Burleson & Goldberger 2002; Dennis et al., 2004; Azrin, Donohue, Teichner, Crum, Howell & DeCato 2001; Liddle et al., 2001; Liddle, Dakof, Turner, Henderson & Greenbaum, 2008; Latimer, Winters, D'Zurilla & Nichols, 2003). Several reviews (that for the most lack pre-published protocols)7 on CBT interventions targeting young drug users already exist (Waldron & Kaminer, 2004; Vaughn & Howard, 2004; Becker & Curry 2008; Waldron & Turner 2008; Lipsey, Tanner-Smith, & Wilson, 2010). However, with only one exception (Waldron & Kaminer, 2004), all of the abovefocus broadly on psychosocial therapies in general, rather than CBT specifically. Generally, the most recent reviews conclude that CBT is associated with reduced drug use in young people (Waldron & Kaminer, 2004; Waldron & Turner, 2008; Lipsey, Tanner-Smith, & Wilson et al., 2010). The findings of the aforementioned studies and reviews indicate that CBT can reduce drug use in young people in treatment. However, closer interpretation of findings reveals a complex picture that is far from clear cut. CBTs reduction in drug use is relative to the comparison interventions used in the individual studies (Lipsey, Tanner-Smith, & Wilson, 2010) and dependent on the types of CBT interventions and modalities used in the studies. Lack of research on mechanisms of change specifically underpinning CBT (Waldron & Kaminer, 2004)makeany identification of key mechanisms speculative. Nevertheless, problem solving and coping strategy skills may be a key to change. Myers and Brown (1990) found that young drug abstainers and minor relapsers had higher levels of these skills than major relapsers and non-abstainers. The particular focus of CBT for substance abuse on problem solving, coping strategies, communication and social skills may support younger people positively in abstaining and dealing with possible relapse. Whether certain population characteristics moderate CBT outcomes for non-opiates remains largely unknown (Morgenstern & McKay, 2007). In a study including 13 to 18 year olds Kaminer, Burleson and Goldberger (1998) found that only older males in the CBT group had a significant reduction in drug use in comparison to the psychoeducational therapy group. This could indicate that CBT is more appropriate forthe older males in the study (i.e., 16 to 18 year olds). Alternatively, the group delivery aspect may provide an additional explanation. Study findings suggest that group CBT has a greater effect in reducing drug use than individual CBT (Waldron, Slesnick, Brody, Peterson & Turner, 2011; Liddle, Rowe, Dakof, Ungaro, & Henderson, 2004). The group aspect may be a more conducive and realistic setting for practicing new skills and strategies with peers in the same situation. The group environment may also contribute to the support and promotion of cognitive and behavioural change among participants (Waldron & Kaminer, 2004). Finally, the clients' motivation also plays an important role, as the more motivated the client is to change, the better the engagement, attendance and outcome of the therapy should be (Waldron & Turner, 2008), although this finding seems to apply to all drug treatment therapies. The duration of therapy may also moderate treatment outcomes and several studies found that shorter CBT interventions were more than, or just as effective as longer durations (Dennis et al., 2004; Kaminer, 2008). Drug use among young people is strongly associated with delinquency, poor scholastic attainment, mental and physical health problems, suicide and other individual or public calamities (Lynskey & Hall, 2000; Tims et al., 2002; Essau, 2006; Rowe & Liddle, 2006; Knudsen, 2009). Yet research has documented a significant gap between young people in need of treatment and young people actually receiving treatment8. McLellan (2006) linked this treatment gap to a public concern regarding the effectiveness of the available treatments for young people and suggests that the public feeling is that nothing works for substance use among young people. There is a need for identifying effective interventions for young drug users to inform treatment policy and practitioners' decisions. Current evidence suggests that CBT for the treatment of young people's drug use is a promising intervention. Research also points to the need for more solid and specific knowledge on what moderates CBT treatment effects, and for whom (Moos, 2007; Kaminer & Waldron 2006; Kaminer 2008; Waldron & Turner, 2008). A protocol-led systematic review on CBT for non-opioid druguse in young people has the potential to provide this knowledge and inform policy and practice. The objective of this review is to assess the effectiveness of CBT for young people (aged 13-21) in outpatient treatment for non-opioid drug use and to explore factors that may moderate positive outcomes. The rationale for including NRCTs is as follows: The aim of this review is to be as comprehensive as possible. There may be information that is contained in NRCTs that may be of relevance to this review that are not captured in RCTs. The population to be included in this reviewis young people aged 13-21years, enrolled in a CBT outpatient drug treatment for non-opioid drug use (e.g., cannabis, amphetamine, ecstasy or cocaine). Definitions of young people, and the age in which a person is considered a young person and may be entitled special services, such as drug treatment varies internationally (United Nations, 2011). Age group distinctions for young people are unclear as the boundaries are fluid and culturally specific (Weller, 2006). Furthermore young people start experimenting with illegal drugs at different ages in different countries (Hibell et al., 2009). Patterns of young people's independence from parents and independent living patterns likewise vary internationally. In order to capture international differences we have set the age range from 13 to 21 (Hibell et al., 2009; United National, 2011; SAMHAS 2010; Danish Youth Council, 2011).A study with age groups well beyond the 13 to 21 age threshold, for example a study with 13 to 65 year olds will only be included if they report findings by age group for the intervention and control group. No universal international consensus exists concerning what categories to use when classifying drug users, and different assessment tools and ways of classifying the severity of drug use are applied in different research studies (American Psychiatric Association, 2000; WHO, 2011; Nordegren, 2002). We include participants regardless of formal drug use diagnosis. The main criterion for inclusion is that the young person is enrolled in treatment for drug use (i.e., intervention or comparison condition). Referral to and enrolment in treatment requires a level of drug use, such that the young person, his/her parent or significant other, or a representative of a statutory authority found it necessary to solicit or require treatment. We therefore define the population as young peoplereferred to or in treatment for using non-opioiddrugs. The focus of this review is on non-opioid use to avoid duplication of effect, as psychosocial interventions for the treatment of youth opioid use have been evaluated in Cochrane reviews (Amato et al., 2011; Minozzi et al., 2010). We will include participants with poly-drug use as long as the majority of drug users in the study are non-opioid users. Study populations with severe mental illnesses (e.g., schizophrenia, psychoticillness) will be excluded. We expect that some study populations may include young people with ‘common’ non-severe comorbid conditions (e.g.,behavioral, emotional, mental health issues)(Hawkins, 2009). These studies will not be excluded as long as the CBT intervention's focus is on treating drug use9. A study will be excluded if the primary intervention focus is to treat the comorbid condition (e.g., depression) in young people who also use drugs. The review will include outpatient CBT interventions(as defined in section 1.2,Description of the intervention) of any duration delivered to young people individually or in groups (e.g., peers or families), described by the authors as CBT or judged by the review authors to represent CBT. We will only include studies with CBT interventions specifically directed at treating ‘young people‘ for non-opioid drug use. The intervention must be an outpatient intervention that does not include overnight stays in a hospital or other treatment facility. The CBT intervention can take place in the home, at community centres, in a therapist's office or at outpatient facilities, and can be delivered to individuals, groups, families and a combination of these CBT interventions conducted by non-professionals (e.g., lay volunteers) will be excluded. Interventions in restrictive environments, such as prisons or other locked institutions (e.g., detention centres. institutions for sentence-serving juvenile delinquents) will be excluded. Interventions focusing exclusively on treating mental disorders will also be excluded Studies where CBT is delivered in combination with add-on components (such as motivationalinterviewing) will be included as long as CBT is the primary intervention. Eligible control and comparisons will include no intervention, waitlist controls and alternative interventions, as we are interested in both absolute and relative effects. Due to ethical considerations and nature of the problem (i.e., young peoples' drug use) the likelihood of a no-treatment control group is small. We expect that the most frequent comparison will be alternative interventions (Lipsey, Tanner-Smith, & Wilson, 2010). Alternative interventions as the comparison will complicate synthesis possibilities and analyses. We will pay careful attention to the types of comparison as is reflected in the Data Synthesis section (3.4). Relevant studies will be identified through electronic searches of the following bibliographic databases and government policy databanks. No language or date restrictions will be applied to the searches. MEDLINE EMBASE CINAHL Web of Science SocIndex PsycINFO Cochrane Controlled Trial Register (CENTRAL) Bibliotek.dk LIBRIS BIBSYS Social Care Online ERIC SweMed+ Criminal Justice Abstracts Bibliography of Nordic Criminology (up to summer 2008) An example of the search strategy for MEDLINE on the OVID platform is listed below. The strategy will be modified for the different databases. We will report full details of the modifications used for other databases in the completed review. The review authors will check the reference lists of other relevant reviews and included primary studies to identify new leads. Citation searching in the Web of Science will also be considered. In addition, we will contact international experts to identify unpublished and on-going studies. We will use Google and Google Scholar search engines and the advanced search options to search the web to identify potential unpublished and/or studies in progress. We will check the first 150 hits.OpenSIGLE(http://opensigle.inistfr/) and OpenGrey (http://www.opengrey.eu/) will also be used to search for European grey literature. Sites such as NCJRS: National Criminal Justice Reference Service will be searched. Copies of relevant documents will be storedand we will record the exact URL and date of access. In addition we will search the following websites: National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov/nidahome.htm The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) http://www.emcdda.europa.eu/index.cfm Substance abuse and Mental Health Services administration (SAMHSA) http://www.samhsa.gov/ Two members of the review team (AK & SF10) will independently screen titles and abstracts in order to exclude studies that are clearly irrelevant under the supervision of the first author (KK). Studies considered eligible by at least one of the review authors will be retrieved in full text. The full texts will then be screened by two members of the review team to determine study eligibility based on the inclusion criteria. Any disagreements about eligibility will be resolved by a third review author (TF). We will check for multiple publications of studies (i.e., whether several studies are based on the same data source). Reasons for exclusion will be documented for each study that is retrieved in full text. The study inclusion coding sheet will be piloted and adjusted if required by the review authors (see Appendix 6.1). The overall search and screening process will be illustrated in a flow-diagram. Two review authors (KK & AK) will independently code and extract data from the included studies. A data extraction sheet will be piloted on several studies and revised as necessary (see Appendix 6.2). Extracted data will be stored electronically. Any disagreements will be resolved by consulting a third reviewer with extensive content and methods expertise (TF). Analysis will be conducted in RevMan5 and/or STATA. Data and information will be extracted on: characteristics of participants (e.g., age, gender, drug use severity and history), intervention characteristics and control conditions, research design, sample size, outcomes, and results. The refined assessment is pertinent when thinking of data synthesis as it operationalizes the identification of studies (especially in relation to non-randomised studies) with a very high risk of bias. The refinement increases transparency in assessment judgments and provides justification for not including a study with a very high risk of bias in the meta-analysis. The risk of bias model used in this review is based on 9 items (for guidelines and coding sheets see Appendices 3 and 4). The assessment will be based on pre-specified questions (see Appendix 3).“Yes” indicates a low risk, “No” indicates a high risk of bias, “and ”Unclear“ indicates an unclear or unknown risk of bias. In the 5 point scale 1 corresponds to No/Low risk of bias (e.g., 1 = a high quality RCT) and 5 corresponds to Yes/High risk of bias (e.g., 5= too risky, too much bias, e.g., a poor quality study). A judgment of five on any item assessedtranslates to a risk of bias so high that the findings will not be considered in the data synthesis (because they are more likely to mislead than inform). An important part of the risk of bias assessment of non-randomised studies is how the studies deal with confounding factors. Selection bias is understood as systematic baseline differences between interventionvs.control (or comparison) groups that can compromise their comparability. We will code baseline equivalence of groups for the NRCTs. For this review, the following confounding factors are considered to be the most relevant: age, gender, and drug history (including drug severity). If other confounders are considered by study investigators in the included studies they will be assessed in the same manner (Appendix 4). We focus on the three confounders - age, gender and drug use history -as they are major predictors of drug use. Young people are in a transitional and developmental life phase, and their patterns of drug use are connected to age (Labouvie & White 2002; Kaminer 2008; Waldron & Kaminer 2004). Gender is also identified as a confounding factor, becausemales generally have higher drug use than females (Østergaard & Bastholm Andrade, 2011; McCabe et al., 2007). And finally, history of drug use and persistent patterns of use affect treatment outcomes (Labouvie & White, 2002; Kaminer, 2008). Review authors (at least two, AK & KK) will independently assess the risk of bias for each included study as described in the previous sections. Disagreements will be solved by a third review author with content and statistical expertise (TF). We will report the risk of bias assessments in risk of bias tables for each included study