Family Consultation for Health-Compromised Smokers

Nicotine Dependence Clinical Trial

Official title:

Phase 1 Study of Family Consultation for Change-Resistant Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400751
• Other study ID #: R21DA013121
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: November 16, 2006
• Start date: September 1999
• Est. completion date: May 2003

Study information

• Verified date: September 1999
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• patient has a diagnosed heart/lung problem or 2+ CAD risk factors

• patient smoked at least 10 cigarettes per day on average for the previous 6 months

• couple married or living in a committed relationship for at least 2 years

• both partners at least 30 years old

• both partners able to read and speak English

• both partners willing to participate in FAMCON

• at least one smoker in the couple hopes to quit within the next two years

Exclusion Criteria:

• terminal illness with life expectancy less that 5 years

• pregnancy

• history of mania or psychosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Behavioral:
• FAMCON (Family Consultation)

Locations

Country	Name	City	State
United States	University of Arizona, Family Research Laboratory, Dept of Psychology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report
Primary	Percent days abstinence Smoker and spouse report
Primary	Urges to smoke (self reports)
Secondary	Health (SF-36)
Secondary	Marital Satisfaction (Hendrick & Hendrick, 1993)
Secondary	State Relationship Questionnaire

External Links

•   PI's personal page