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Family Consultation for Health-Compromised Smokers

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FAMCON (Family Consultation)
Sponsored by
University of Arizona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Health-compromised smokers, family cessation intervention

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona, Family Research Laboratory, Dept of Psychology

Outcomes

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

Full Information

First Posted
November 15, 2006
Last Updated
November 16, 2006
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT00400751
Brief Title
Family Consultation for Health-Compromised Smokers
Official Title
Phase 1 Study of Family Consultation for Change-Resistant Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 1999
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arizona

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Health-compromised smokers, family cessation intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
FAMCON (Family Consultation)
Primary Outcome Measure Information:
Title
Point-Prevalence (PP): 30-day abstinence: Smoker and spouse report
Title
Percent days abstinence Smoker and spouse report
Title
Urges to smoke (self reports)
Secondary Outcome Measure Information:
Title
Health (SF-36)
Title
Marital Satisfaction (Hendrick & Hendrick, 1993)
Title
State Relationship Questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varda Shoham, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Rohrbaugh, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona, Family Research Laboratory, Dept of Psychology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721-0068
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.u.arizona.edu/~varda/
Description
PI's personal page

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Family Consultation for Health-Compromised Smokers

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