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

NCT00435903 | Unknown Early Phase 1

• 1 other identifier: CORRC #21-04
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Keywords

smoking; self-monitoring; major mental illness; palm pilots; subjects with DSM-IV Axis I diagnosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Interventions

Palm Pilot DEVICE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50
• Having a DSM-IV psychiatric diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or major depression with significant functional impairment
• Smoking 10 or more cigarettes per day
• Having an expired air minimum CO of at least 10 ppm
• 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)
• Stable psychiatric symptoms

You may not qualify if:

• Mini Mental State exam score less than 24/30
• Currently using nicotine replacement therapy
• Diagnosis of dementia, neurodegenerative disease, substance abuse or dependence disorders (to substances other than nicotine) active within the last 3 months
• Patients who, in the investigator's opinion, pose a current homicide or suicide risk

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Michelle Friedman-Yakoobian, Ph.D.

  Freedom Trail Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2007
• First Posted: February 16, 2007
• Study Start: June 1, 2005
• Study Completion: October 1, 2005
• Last Updated: May 18, 2009

Record last verified: 2007-02

Locations

US (1)