Computerized Alcohol Misuse Intervention System for Health Care (CAMI)
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|ClinicalTrials.gov Identifier: NCT02368899|
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Other: Computerized Alcohol Misuse Intervention Other: Attention Control (AC)||Not Applicable|
|Study Type :||Interventional|
|Actual Enrollment :||61 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Micro-targeted Computerized Alcohol Misuse Intervention System for Health Care|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||April 17, 2017|
|Actual Study Completion Date :||April 17, 2017|
Experimental: Computerized Alcohol Misuse Intervention
Arm 1 is a cross-over randomized controlled trial (XRCT) comparing the short-term effects of the computerized alcohol misuse intervention (CAMI) vs. a generic health education attention-control (AC) condition in reducing past 30 day: (a) days of alcohol use, (b) days of heavy episodic drinking, (c) typical number of drinks consumed on a day of drinking, and (d) alcohol use in dangerous situations; (2) investigate changes in (a) patient motivation and (b) perceived norms as mediators of intervention effectiveness.
Other: Computerized Alcohol Misuse Intervention
Interventionaire© is a computerized alcohol misuse intervention that includes a normative feedback component unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services.
Other Name: Interventionaire©
Placebo Comparator: Attention Control (AC)
Arm 2 is not an active intervention but an attention control condition - it is not expected to exert any real intervention effect. Hence, any observed effects for the AC condition can be attributed to natural change via regression-to-the-mean, assessment reactivity, or a placebo effect. The effect size estimate of the intervention, both from an efficacy standpoint (i.e., above and beyond what change would have normally occurred) and an effectiveness standpoint (i.e., the magnitude of behavior change that can be expected in real-world implementation), can be readily calculated.
Other: Attention Control (AC)
These products are designed for entertainment and educational purposes only. No medical claims are made for them and, the participant's interaction with them should be conceptually unrelated to alcohol use behavior.In order to avoid any carryover effect from comparing two active treatments, we have chosen to use a simple attention control condition that is not expected to exert any real intervention effect. In that way, the effect size estimate of the intervention can be readily calculated. No research data will be collected as part of the AC, beyond the amount of time spent on the program.
Other Name: RoboMemo, Luminosity, etc.
- Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI) [ Time Frame: Month 1 and Month 2 ]At one month, the investigators expect the attention control group (A) to reduce their alcohol use somewhat, but the intervention group (B) is expected to show a much steeper reduction. Thus, the investigators first planned contrast tests A vs. B, and can be considered similar to a parallel group trial examining 1-month outcomes for intervention vs. attention control. After the cross-over at 1 month, the magnitude of the reduction from Month 1 to Month 2 for those receiving the intervention (C) is expected to be similar to that experienced by those who received the intervention initially.
- Changes in participant motivation to stop or cut down alcohol use as measured by self-reported interest in reduction of alcohol use after completing the computerized alcohol misuse intervention (CAMI) [ Time Frame: Month 1 and Month 2 ]It is expected that the effect of CAMI will be carried by changes in motivation and changes in perceived norms.The investigators will use advanced modern mediation analysis techniques to investigate the mechanisms that may drive reductions in drinking.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368899
|United States, Maryland|
|Family Health Centers of Baltimore|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Diana H Caldwell, PhD||Research Circle Associates|
|Study Director:||Arti P Varanasi, PhD, MPH||Advancing Synergy|