Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00400751
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2006-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family Consultation for Health-Compromised Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-09', 'completionDateStruct': {'date': '2003-05'}, 'lastUpdateSubmitDate': '2006-11-16', 'studyFirstSubmitDate': '2006-11-15', 'studyFirstSubmitQcDate': '2006-11-16', 'lastUpdatePostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report'}, {'measure': 'Percent days abstinence Smoker and spouse report'}, {'measure': 'Urges to smoke (self reports)'}], 'secondaryOutcomes': [{'measure': 'Health (SF-36)'}, {'measure': 'Marital Satisfaction (Hendrick & Hendrick, 1993)'}, {'measure': 'State Relationship Questionnaire'}]}, 'conditionsModule': {'keywords': ['Health-compromised smokers, family cessation intervention'], 'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Although spousal support predicts the success of a smoker\'s cessation efforts, "social support" interventions based on teaching partners better support skills have had consistently disappointing results. We examined the potential utility of a family-consultation (FAMCON) intervention based on family-systems theory in a treatment-development project involving 20 couples in which one partner (the primary smoker) continued to smoke despite having or being at significant risk for heart or lung disease. Results were promising. The 50% rate of stable abstinence achieved by primary smokers over at least 6 months exceeds benchmark success rates reported in the literature for other, comparably intensive interventions, suggesting that a couple-focused intervention different in concept and format from social-support interventions tested in the past may hold promise for health-compromised smokers. The FAMCON approach appeared particularly well-suited to female smokers and smokers whose partner also smoked - two sub-groups at high risk for relapse.', 'detailedDescription': 'Although spousal support predicts the success of a smoker\'s cessation efforts, "social support" interventions based on teaching partners better support skills have had consistently disappointing results. In this Stage I (treatment development) study we examined the potential utility of a family-consultation (FAMCON) intervention based on family-systems theory.\n\nSpecifically, in this Phase-I study we developed, standardized, and pilot tested a systemic, couple-focused treatment for change-resistant smokers based on the assumption that a smoker\'s marital and family relationships play a key role in whether he or she continues to smoke.\n\nThe intervention provides up to 10 sessions of "family consultation" over 2-5 months to single- or dual-smoker couples in which at least one partner continued to smoke despite having lung disease, heart disease, or multiple cardiac risk factors.\n\nThe treatment focuses on the immediate social context of smoking, aiming both to interrupt well-intended "solutions" that ironically feed back to keep smoking going, and to help clients realign important relationships in ways not organized around tobacco use.\n\nParticipants were 20 couples in which one partner (the primary smoker) continued to smoke despite having or being at significant risk for heart or lung disease.\n\nResults are promising. The 50% rate of stable abstinence achieved by primary smokers over 6 months (with 63% abstinence rates for secondary smokers) exceeds benchmark success rates reported in the literature for other, comparably intensive interventions, suggesting that a couple-focused intervention different in concept and format from social-support interventions tested in the past may hold promise for health-compromised smokers. The12-month cessation rates were 40% for primary smokers and 63% for secondary smokers.\n\nThe FAMCON approach appeared particularly well-suited to female smokers and smokers whose partner also smoked - two sub-groups at high risk for relapse.\n\nReferences:\n\nRohrbaugh, M.J., Shoham, V., Trost, S., Muramoto, M., Cate, R., \\& Leischow, S. (2001). Couple-dynamics of change resistant smoking: Toward a family-consultation model. Family Process, 40, 15 - 31.\n\nShoham, V., Rohrbaugh, M.J., Trost, S.E., \\& Muramoto, M. (in press). A family consultation (FAMCON) intervention for health-compromised smokers. Journal of Substance Abuse Treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient has a diagnosed heart/lung problem or 2+ CAD risk factors\n* patient smoked at least 10 cigarettes per day on average for the previous 6 months\n* couple married or living in a committed relationship for at least 2 years\n* both partners at least 30 years old\n* both partners able to read and speak English\n* both partners willing to participate in FAMCON\n* at least one smoker in the couple hopes to quit within the next two years\n\nExclusion Criteria:\n\n* terminal illness with life expectancy less that 5 years\n* pregnancy\n* history of mania or psychosis'}, 'identificationModule': {'nctId': 'NCT00400751', 'briefTitle': 'Family Consultation for Health-Compromised Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Phase 1 Study of Family Consultation for Change-Resistant Smokers', 'orgStudyIdInfo': {'id': 'R21DA013121', 'link': 'https://reporter.nih.gov/quickSearch/R21DA013121', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FAMCON (Family Consultation)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721-0068', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Family Research Laboratory, Dept of Psychology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Varda Shoham, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}, {'name': 'Michael J. Rohrbaugh, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}}}}