Viewing Study NCT00400751


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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: University of Arizona
Organization:

Study Overview

Official Title: Phase 1 Study of Family Consultation for Change-Resistant Smokers
Status: COMPLETED
Status Verified Date: 1999-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: 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.

Specifically, 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.

The 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.

The 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.

Participants 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.

Results 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.

The FAMCON approach appeared particularly well-suited to female smokers and smokers whose partner also smoked - two sub-groups at high risk for relapse.

References:

Rohrbaugh, 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.

Shoham, 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.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: