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
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Behavioral: FAMCON (Family Consultation)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Family Consultation for Change-Resistant Smokers

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report
  • Percent days abstinence Smoker and spouse report
  • Urges to smoke (self reports)

Secondary Outcome Measures:
  • Health (SF-36)
  • Marital Satisfaction (Hendrick & Hendrick, 1993)
  • State Relationship Questionnaire

Estimated Enrollment: 40
Study Start Date: September 1999
Estimated Study Completion Date: May 2003
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400751

Locations
United States, Arizona
University of Arizona, Family Research Laboratory, Dept of Psychology
Tucson, Arizona, United States, 85721-0068
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Varda Shoham, Ph.D. University of Arizona
Study Director: Michael J. Rohrbaugh, Ph.D. University of Arizona
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00400751     History of Changes
Other Study ID Numbers: R21 DA13121
Study First Received: November 15, 2006
Last Updated: November 16, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Health-compromised smokers, family cessation intervention

ClinicalTrials.gov processed this record on September 30, 2014