Family Consultation for Health-Compromised Smokers

November 16, 2006 updated by: University of Arizona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721-0068
        • University of Arizona, Family Research Laboratory, Dept of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Health (SF-36)
Marital Satisfaction (Hendrick & Hendrick, 1993)
State Relationship Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Varda Shoham, Ph.D., University of Arizona
  • Study Director: Michael J. Rohrbaugh, Ph.D., University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

May 1, 2003

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (ESTIMATE)

November 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2006

Last Update Submitted That Met QC Criteria

November 16, 2006

Last Verified

September 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DA013121 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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