An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol

BMC Psychiatry

Paul S Haber³  Ronald M Rapee²  Maree Teesson¹  Lexine A Stapinski²  Claudia Sannibale⁴  Andrew J Baillie² 

[1] National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia;Centre for Emotional Health, Psychology Department, Macquarie University, Sydney, Australia;Sydney Medical School, University of Sydney, Camperdown, Australia;Drug Health Services, Royal Prince Alfred Hospital, Camperdown, Australia

关键词: Clinical trial;    Cognitive behavior therapy;    Comorbidity;    Social anxiety disorder;    Alcohol use disorders;   

Others  :  1123994
DOI  :  10.1186/1471-244X-13-199

 received in 2013-07-23, accepted in 2013-07-24,  发布年份 2013

【 摘 要 】

Background

Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment.

Methods/design

A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation.

Discussion

The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12608000228381.

【 授权许可】

   
2013 Baillie et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Merikangas KR, Stevens DE, Fenton B, Stolar M, O’Malley S, Woods SW, Risch N: Co-morbidity and familial aggregation of alcoholism and anxiety disorders. Psychol Med 1998, 28:773-778.
• [2]Morris EP, Stewart SH, Ham LS: The relationship between social anxiety disorder and alcohol use disorders: a critical review. Clin Psychol Rev 2005, 25:734-760.
• [3]Kushner MG, Abrams K, Borchardt C: The relationship between anxiety disorders and alcohol use disorders: a review of major perspectives and findings. Clin Psychol Rev 2000, 20:149-171.
• [4]Randall CL, Thomas S, Thevos AK: Concurrent alcoholism and social anxiety disorder: a first step toward developing effective treatments. Alcohol Clin Exp Res 2001, 25:210-220.
• [5]Schadé A, Marquenie LA, van Balkom AJ, Koeter MW, de Beurs E, van den Brink W, van Dyck R: The effectiveness of anxiety treatment on alcohol-dependent patients with a comorbid phobic disorder: a randomized controlled trial. Alcohol Clin Exp Res 2005, 29:794-800.
• [6]Burns L, Teesson M: The epidemiology of comorbid alcohol, anxiety and depressive disorders. Drug Alcohol Depend 2002, 68:299-307.
• [7]Teesson M, Hall W, Lynskey M, Degenhardt L: Alcohol- and drug-use disorders in Australia: implications of the National Survey of Mental Health and Wellbeing. Aust N Z J Psychiatry 2000, 34:206-213.
• [8]Teesson M, Proudfoot H: Responding to comorbid mental disorders and substance use disorders. In Comorbid mental disorders and substance use disorders: epidemiology, prevention and treatment. Edited by Teesson M, Proudfoot H. Canberra, Australia: Australian Government Department of Health and Ageing; 2003:1-8.
• [9]Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC: Lifetime Co-occurrence of DSM-III-R Alcohol Abuse and Dependence With Other Psychiatric Disorders in the National Comorbidity Survey. Arch Gen Psychiatry 1997, 54:313-321.
• [10]Regier DA, Farmer ME, Donald SR, Locke BZ, Keith SJ, Judd LL, Goodwin FK: Comorbidity of mental disorders with alcohol and other drug abuse. JAMA 1990, 264:2511-2518.
• [11]Ross HE: DSM-III-R alcohol abuse and dependence and psychiatric comorbidity in Ontario: Results from the Mental Health Supplement to the Ontario Health Survey. Drug Alcohol Depend 1995, 39:111-128.
• [12]Kessler RC, Nelson CB, McGonagle KA, Edlund MJ, Frank RG, Leaf PJ: The epidemiology of co-occurring addictive and mental disorders: implications for prevention and service utilisation. Am J Orthopsychiatry 1996, 66:17-31.
• [13]Degenhardt L: National Drug and Alcohol Research Centre. 2000.
• [14]Schneider U, Altmann A, Baumann M, Bernzen J, Bertz B, Bimber U, Broese T, Broocks A, Burtscheidt W, Cimander KF, et al.: Comorbid anxiety and affective disorder in alcohol-dependent patients seeking treatment: the first Multicentre Study in Germany. Alcohol Alcohol 2001, 36:219-223.
• [15]Barlow DH: Anxiety disorders, comorbid substance abuse, and benzodiazepine discontinuation: implications for treatment. In Treatment of Drug-Dependent Individuals With Comorbid Mental Disorders, Volume 172. Edited by Onken LS, Blaine JD, Genser S, Horton AM, JR Rockville MD. National Institute on Drug Abuse; 1997:33-50. NIDA Research Monograph]
• [16]Farrell M, Howes S, Taylor C, Lewis G, Jenkins R, Bebbington P, Jarvis M, Brugha T, Gill B, Meltzer H: Substance misuse and psychiatric comorbidity: an overview of the OPCS national psychiatric morbidity survey. Addict Behav 1998, 23:909-918.
• [17]Project MATCH Research Group: Matching Alcoholism treatments to client heterogeneity: project MATCH posttreatment drinking outcomes. J Stud Alcohol 1997, 58:7-29.
• [18]Bakken K, Landheim A, Vaglum P: Substance-dependent patients with and without social anxiety disorder: Occurrence and clinical differences: a study of a consecutive sample of alcohol-dependent and poly-substance-dependent patients treated in two counties in Norway. Drug Alcohol Depend 2005, 80:321-328.
• [19]Bakken K, Landheim AS, Vaglum P: Primary and secondary substance misusers: do they differ in substance-induced and substance-independent mental disorders? Alcohol Alcohol 2003, 38:54-59.
• [20]Cox BJ, Norton GR, Swinson RP, Endler NS: Substance abuse and panic-related anxiety: a critical review. Behav Res Ther 1990, 28:385-393.
• [21]Schuckit MA, Tipp JE, Bucholz KK, Nurnberger JI Jr, Hesselbrock VM, Crowe RR, Kramer J: The life-time rates of three major mood disorders and four major anxiety disorders in alcoholics and controls. Addict 1997, 92:1289-1304.
• [22]Schuckit MA, Hesselbrock V: Alcohol dependence and anxiety disorders: what is the relationship? Am J Psychiatry 1994, 151:1723-1734.
• [23]Schuckit MA, Monteiro MG: Alcoholism, anxiety and depression. Br J Addict 1988, 83:1373-1380.
• [24]Greeley J, Oei T: Alcohol and tension reduction. In Psychological theories of drinking and alcoholism. 2nd edition. Edited by Leonard KE, Blane HT. New York, NY: Guilford Press; 1999:14-53. [The Guilford substance abuse series]
• [25]Khantizian EJ: The self-medication hypothesis of addictive disorders: focus on heroin and cocaine dependence. Am J Psychiatry 1985, 142:1259-1264.
• [26]Carrigan MH, Randall CL: Self-medication in social phobia: a review of the alcohol literature. Addict Behav 2003, 28:269-284.
• [27]Sannibale C: The differential effects of a set of brief interventions on the functioning of a group of “early stage” problem drinkers. Aust Drug Alcohol Rev 1989, 7:147-157.
• [28]Sannibale C: A prospective study of treatment outcome with a group of male problem drinkers. J Stud Alcohol 1989, 50:236-245.
• [29]Shand FL, Gates J, Fawcess J, Mattick RP: The treatment of alcohol problems: A review of the evidence. Canberra: Commonwealth Department of Health and Ageing; 2003.
• [30]Sobell MB, Sobell LC: Stepped care as a heuristic approach to the treatment of alcohol problems. J Consult Clin Psychol 2000, 68:573-579.
• [31]Driessen M, Meier S, Hill A, Wetterling T, Lange W, Junghanns K: The course of anxiety, depression and drinking behaviours after completed detoxification in alcoholics with and without comorbid anxiety and depressive disorders. Alcohol Alcohol 2001, 36:249-255.
• [32]Marquenie LA, Schade A, Van Balkom AJ, Koeter MW, Frenken S, Van Den Brink W, Van Dyck R: Comorbid phobic disorders do not influence outcome of alcohol Dependence treatment. Results of a naturalistic follow-up study. Alcohol Alcohol 2006, 41:168-173.
• [33]Terra MB, Barros HMT, Stein AT, Figueira I, Athayde LD, Spanemberg L, De Aguiar Possa M, Filho LD, Da Silveira DX: Does co-occurring social phobia interfere with alcoholism treatment adherence and relapse? J Subst Abuse Treat 2006, 31:403-409.
• [34]Tómasson K, Vaglum P: A nationwide representative sample of treatment-seeking alcoholics: a study of psychiatric comorbidity. Acta Psychiatr Scand 1995, 92:378-385.
• [35]Tómasson K, Vaglum P: Psychopathology and alcohol consumption among treatment-seeking alcoholics: a prospective study. Addict 1996, 91:1019-1030.
• [36]Tómasson K, Vaglum P: The 2-year course following detoxification treatment of substance abuse: the possible influence of psychiatric comorbidity. Eur Arch Psychiatry Clin Neurosci 1997, 247:320-327.
• [37]Tómasson K, Vaglum P: The role of psychiatric comorbidity in the prediction of readmission for detoxification. Compr Psychiatry 1998, 39:129-136.
• [38]Heimberg R, Dodge C, Hope D, Kennedy C, Zollo L, Becker R: Cognitive behavioral group treatment for social phobia: comparison with a credible placebo control. Cogn Ther Res 1990, 14:1-23.
• [39]Clark DM, Ehlers A, Hackmann A, McManus F, Fennell M, Grey N, Waddington L, Wild J: Cognitive therapy versus exposure and applied relaxation in social phobia: a randomized controlled trial. J Consult Clin Psychol 2006, 74:568-578.
• [40]Rapee RM, Gaston JE, Abbott MJ: Testing the efficacy of theoretically derived improvements in the treatment of social phobia. J Consult Clin Psychol 2009, 77:317-327.
• [41]Mattick RP, Peters L: Treatment of severe social phobia: effects of guided exposure with and without cognitive restructuring. J Consult Clin Psychol 1988, 56:251-260.
• [42]Mattick RP, Peters L, Clark JC: Exposure and ocgnitive restructuring for social phobia. Behav Ther 1989, 20:3-23.
• [43]Turk CL, Heimberg RG, Hope DA: Social anxiety disorder. In Clinical handbook of psychological disorders: A step-by-step treatment manual. 3rd edition. New York, NY US: Guilford Press; 2001:114-153.
• [44]McEvoy PM, Shand F: The effect of comorbid substance use disorders on treatment outcome for anxiety disorders. J Anxiety Disord 2008, 22:1087-1098.
• [45]Baillie A, Rapee R: Panic and Agoraphobia. In Diagnosis, Conceptualisation, and Treatment Planning for Adults: A Textbook. Edited by Hersen M, Porzelius LK. Mahwah, NJ: Lawrence Erlbaum Associates; 2001:113-132.
• [46]Baillie A, Rapee RM: Predicting who benefits from psychoeducation and self help for panic attacks. Behav Res Ther 2004, 42:513-527.
• [47]Rapee RM, Sanderson WC: Social Phobia: Clinical application of evidence-based psychotherapy. North Bergen, NJ: Jason Aronson Inc; 1998.
• [48]Rapee RM: Overcoming Shyness and Social Phobia: A Step-by-Step Guide. 2nd edition. Sydney: Lifestyle Press; 2001.
• [49]Rapee RM: Descriptive psychopathology of social phobia. In Social phobia: Diagnosis, assessment, and treatment. New York, NY US: Guilford Press; 1995:41-66.
• [50]Rapee RM, Heimberg RG: A cognitive-behavioral model of anxiety in social phobia. Behav Res Ther 1997, 35:741-756.
• [51]Rapee RM, Abbott MJ, Baillie AJ, Gaston JE: Treatment of social phobia through pure self help and therapist-augmented self help. Br J Psychiatry 2007, 191:246-252.
• [52]Jones EE, Berglas S: Control of attributions about the self through self-handicaping strategies: the appeal of alcohol and the role of underachievement. Pers Soc Psychol Bull 1978, 4:200-206.
• [53]Morley KC, Teesson M, Reid S, Thomson C, Sannibale C, Phung N, Weltman M, Bell J, Richardson K, Haber PS: Naltrexone versus acamprosate in the treatment of alcohol dependence: a multi-centre, randomized, double-blind, placebo-controlled trial. Addict 2006, 101:1451-1462.
• [54]Anton RF, O’Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, et al.: Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence: the COMBINE Study: a Randomized Controlled Trial. JAMA 2006, 295:2003-2017.
• [55]O’Malley SS, AJ J, S R, BJ R: Experience of a “slip” among alcoholics treated with naltrexone or placebo. Am J Psychiatry 1996, 153:281.
• [56]Volpicelli JR, Watson NT, King AC, Sherman CE, O’Brien CP: Effect of naltrexone on alcohol “high” in alcoholics. Am J Psychiatry 1995, 152:613.
• [57]Berglund M: Pharmacotherapy for alcohol dependence. In Treating Alcohol and Drug Abuse: An Evidence-Based Review. Edited by Berglund M, Thelander S, Jonsson E. Weinheim: Wiley-VCH; 2004:247-312.
• [58]Krystal JH, Cramer JA, Krol WF, Kirk GF, Rosenheck RA, Veterans Affairs Naltrexone Cooperative Study 425 Group: Naltrexone in the treatment of alcohol dependence. N Engl J Med 2001, 345:1734-1739.
• [59]Kranzler HR, Modesto-Lowe V, Van Kirk J: Naltrexone vs. nefazodone for treatment of alcohol dependence. A placebo-controlled trial. Neuropsychopharmacol 2000, 22:493-503.
• [60]Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M: Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev 2010, (Issue 12):Art. No.: CD001867.
• [61]Rösner S, Hackl-Herrwerth A, Leucht S, Lehert P, Vecchi S, Soyka M: Acamprosate for alcohol dependence. Cochrane Database Syst Rev 2010, (Issue 9):Art. No.: CD004332.
• [62]Baillie A, Sannibale C: Anxiety and drug and alcohol problems. In Clinical Handbook of Co-existing Mental Health and Drug and Alcohol Problems. Edited by Baker A, Velleman R. London: Brunner-Routledge; 2007:195-214.
• [63]Stapinski LA, Rapee RM, Sannibale C, Teesson M, Habber P, Baillie AJ: The clinical and theoretical basis for integrated cognitive behavioural treatment of co-morbid social phobia & alcohol use disorders. submitted
• [64]Babor TF, Ramon De La Fluente J, Saunders J, Grant M: AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary health care. Geneva: World Health Organization; 1989.
• [65]Connor KM, Kobak KA, Churchill E, Katzelnick D, Davidson JRT: Mini-SPIN: a brief screening assessment for generalized social anxiety disorder. Depress Anxiety 2001, 14:137-140.
• [66]National Health and Medical Research Council: Australian Alcohol Guidelines: Health Risks and Benefits. Canberra, Australia: National Health and Medical Research Council; 2001.
• [67]Bebbington P, Nayani T: The psychosis screening questionnaire. Int J Methods Psychiatr Res 1995, 5:11-19.
• [68]Brown TA: Anxiety Disorders Interview Schedule Adult Version (ADIS-IV): Client Interview Schedule. Oxford: Oxford University Press; 1994.
• [69]Darke S, Hall W, Wodak A, Heather N, Ward J: Development and validation of a multi-dimensional instrument for assessing outcome of treatment among opiate users: the Opiate Treatment Index. Br J Addict 1992, 87:733-742.
• [70]Sullivan J, Sykora K, Schneiderman J, Naranjo C, Sellers E: Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict 1989, 84:1353-1357.
• [71]Allan CA: Alcohol problems and anxiety disorders - a critical review. Alcohol Alcohol 1995, 30:145-151.
• [72]Loranger AW, Janca A, Loranger AW, Janca A, Sartorius N: Assessment and diagnosis of personality disorders: the ICD-10 Iternational Personality Disorder examination (IPDE). Cambridge, UK: Cambridge University Press; 1997.
• [73]Reiss S, Peterson RA, Gursky DM, McNally RJ: Anxiety sensitivity, anxiety frequency and the predictions of fearfulness. Behav Res Ther 1986, 24:1-8.
• [74]Kushner MG, Sher KJ, Wood MD, Wood PK: Anxiety and drinking behavior: moderating effects of tension-reduction alcohol outcome expectancies. Alcohol Clin Exp Res 1994, 18:852-860.
• [75]Sobell LC, Maisto SA, Sobell MB, Cooper A: Reliability of alcohol abusers” self-reports of drinking behavior. Behav Res Ther 1979, 17:157-160.
• [76]Sobell LC, Sobell MB, Leo GI, Cancilla A: Reliability of a timeline method: assessing normal drinkers’ reports of recent drinking and a comparative evaluation across several populations. Br J Addict 1988, 83:393-402.
• [77]Flannery BA, Volpicelli JR, Pettinati HM: Psychometric properties of the Penn Alcohol Craving Scale. Alcohol Clin Exp Res 1999, 23:1289-1295.
• [78]DiClemente CC, Carbonari JP, Montgomeri RPG, Hughes SO: The alcohol abstinence self-efficacy scale. J Stud Alcohol 1994, 55:141-148.
• [79]DiClemente CC, Hughes SO: Stages of change profiles in outpatient alcoholism treatment. J Subst Abuse Treat 1990, 2:217-235.
• [80]McLellan W: Mental Health and Wellbeing: Profile of Adults, Australia. Canberra: Australian Bureau of Statistics; 1997.
• [81]Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX: The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assess 2001, 8:443-454.
• [82]Brown TA, DiNardo P, Barlow DH: Anxiety Disorder Interview Schedule. New York: Oxford: University Press; 2004.
• [83]Mattick RP, Clarke JC: Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Behav Res Ther 1998, 36:455-470.
• [84]Stockwell T, Sitharthan T, McGrath D, Lang E: The measurement of alcohol dependence and impaired control in community samples. Addict 1994, 89:167-174.
• [85]Ware J Jr, Kosinski M, Keller SD: A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
• [86]Sheehan DV, Harnett-Sheehan K, Raj BA: The measurement of disability. Int Clin Psychopharmacol 1996, 11:89-95.
• [87]Lovibond SH, Lovibond PF: Manual for the Depression, Anxiety Stress Scales (DASS). Sydney: Psychology Foundation Monograph; 1993.
• [88]von Korff M, Ustin B, Ormel J, Kaplan I, Simon GE: Self-report disability in an international primary care study of psychologiocal illness. J Clin Epidemiol 1996, 49:297-303.
• [89]Miller WR, Tonigan JS, Longabaugh R: The Drinker Inventory of Consequences (DrInC): An instrument for assessing adverse consequences of alcohol abuse Volume 4. Rockville, Maryland: NIAAA; 1995. Project MATCH Monograph Series
• [90]Brown SA, Christiansen BA, Goldman MS: The alcohol expectancy questionnaire: an instrument for the assessment of adolescent and adult alcohol expectancies. J Stud Alcohol 1987, 48:483-491.
• [91]Bruch MA, Heimberg RG, Harvey C, McCann M, et al.: Shyness, alcohol expectancies, and alcohol use: discovery of a suppressor effect. J Res Pers 1992, 26:137-149.
• [92]Darke S, Ward J, Hall W, Heather N, Wodak A: The Opiate Treatment Index (OTI) Manual. Sydney NSW Australia: National Drug and Alcohol Research Centre; 1991.
• [93]Saladin ME, Ana EJ: Controlled drinking: more than just a controversy. Curr Opin Psychiatry 2004, 17:175-187.
• [94]Miller WR, Rollnick S: Motivational Interviewing: Preparing people for change. 2nd edition. New York: Guilford; 2002.
• [95]Miller WR, Zweben A, DiClemente CC, Rychatrik RG: Motivational enhancement therapy manual. In Project MATCH Monograph Series Vol 2 NIH Pub No 94–3723. Rockville, MD: NIAAA; 1995.
• [96]Kadden R, Carroll KM, Donovan D, Cooney N, Monti P, Abrams D, Litt M, Hester R: Cognitive-Behavioral Coping Skills Therapy Manual: A Clinical Research Guide for Therapists Treating Individuals with Alcohol Abuse and Dependence. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism; 1992.
• [97]Monti PE, Kadden RM, Rohsenow DJ, Abrams DB, Cooney NL: Treating alcohol dependence: A coping skills training guide. 2nd edition. New York: Guilford Press; 2002.
• [98]Young J, Beck AT: Cognitive Therapy Scale Rating Manual Psychotherapy Research Unit. University of Pennsylvania; 1980. http://www.academyofct.org/files/documentlibrary/CTRS_Manual.pdf webcite
• [99]Gibbons RD, Hedeker DR, Elkin I, Waternaux C, Kraemer H, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT: Some conceptual and statistical issues in analysis of longitudinal psychiatric data: application to the NIMH Treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry 1993, 50:739-750.