Family Consultation for Health-Compromised Smokers

This study has been completed.
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00400751
First received: November 15, 2006
Last updated: November 16, 2006
Last verified: September 1999

November 15, 2006
November 16, 2006
September 1999
Not Provided
  • Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report
  • Percent days abstinence Smoker and spouse report
  • Urges to smoke (self reports)
Same as current
Complete list of historical versions of study NCT00400751 on ClinicalTrials.gov Archive Site
  • Health (SF-36)
  • Marital Satisfaction (Hendrick & Hendrick, 1993)
  • State Relationship Questionnaire
Same as current
Not Provided
Not Provided
 
Family Consultation for Health-Compromised Smokers
Phase 1 Study of Family Consultation for Change-Resistant Smokers

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nicotine Dependence
Behavioral: FAMCON (Family Consultation)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2003
Not Provided

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00400751
R21 DA13121
Not Provided
Not Provided
University of Arizona
Not Provided
Principal Investigator: Varda Shoham, Ph.D. University of Arizona
Study Director: Michael J. Rohrbaugh, Ph.D. University of Arizona
University of Arizona
September 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP