N/A
N=162
Randomized Controlled Trial (RCT) of a Motivational Decision Support System
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02086162 ↗Enrolled (actual)
162
Serious AEs
0.6%
Results posted
Oct 2018
Primary outcome: Primary: Number of Subjects That Initiated Cessation Treatment — 27; 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Web-based motivational decision support system (Behavioral); NCI Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Initiated Cessation Treatment |
27; 36 | — |
| SECONDARY Number of Subjects With Confirmed Abstinence |
1; 6 | — |
| SECONDARY Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence |
13; 11 | — |
Summary
In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are:
1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.
3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
Eligibility Criteria
Inclusion Criteria
- 18-70 years old
- DSM-IV-TR diagnosis psychotic disorder
- in treatment at participating mental health center
- current daily smoker
- fluent in English
- physically able to use computer
- willing and able to give informed consent
Exclusion Criteria
- past 2 weeks use of evidence based cessation treatment
- psychiatric instability
- current alcohol or drug dependence
- pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02086162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.