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Pilot Study of the Feasibility of Palm Pilots in Monitoring Smoking Behavior in Individuals With Chronic Mental Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by North Suffolk Mental Health Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00435903
First received: February 14, 2007
Last updated: May 14, 2009
Last verified: February 2007
History of Changes
  Purpose

The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to use a strategy for delaying and reducing cigarette use.


Condition Intervention Phase
Smoking
 Device: Palm Pilot
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pilot Study of the Feasibility of Palm Pilots in Monitoring Smoking Behavior in Individuals With Chronic Mental Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • We will compare palm-recordings with paper and pencil recordings to examine how well these correlate.

Secondary Outcome Measures:
  • Correlations will be used to compare the total number of smoked cigarettes reported by the daily ratings (paper and pencil or palm pilot) to participants' report of their weekly totals.
  • We will measure the frequency at which participants access a screen on the Palm Pilot that presents the "4 D's," which are four strategies for delaying or reducing cigarette use.
  • Repeated measured t-tests will be used to compare participants' cotinine levels before and after participating in this program.
  • We will use an independent samples t-test to compare satisfaction scores for the two monitoring methods.
  • We will assess the degree of compliance with completing the mood rating scale (how many out of 7 were completed in the week) and will compare compliance rates for the Palm and paper-and-pencil versions using an independent samples t-test.
  • We will assess the amount of training time required to train participants to use either the paper and pencil or Palm Pilot versions of the monitoring form.

Estimated Enrollment: 11
Study Start Date: June 2005
Estimated Study Completion Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 50
  2. Having a DSM-IV psychiatric diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or major depression with significant functional impairment
  3. Smoking 10 or more cigarettes per day
  4. Having an expired air minimum CO of at least 10 ppm
  5. Normal or corrected to normal eyesight and adequate manual dexterity to operate a palm pilot (will be assessed on case by case basis with participants completing an initial screening which involves demonstrating basic ability to read the screen on the palm pilot and operate the stylus)
  6. Stable psychiatric symptoms

Exclusion Criteria:

  1. Mini Mental State exam score less than 24/30
  2. Currently using nicotine replacement therapy
  3. Diagnosis of dementia, neurodegenerative disease, substance abuse or dependence disorders (to substances other than nicotine) active within the last 3 months
  4. Patients who, in the investigator's opinion, pose a current homicide or suicide risk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435903

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Investigators
Principal Investigator: Michelle Friedman-Yakoobian, Ph.D. Freedom Trail Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00435903     History of Changes
Other Study ID Numbers: CORRC #21-04
Study First Received: February 14, 2007
Last Updated: May 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:
smoking
self-monitoring
major mental illness
palm pilots
subjects with DSM-IV Axis I diagnosis

Additional relevant MeSH terms:
Mental Disorders
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013