NCT01539525: ProjectSTART

Screening to Augment Referral to Treatment- Project START

Completed NA Results posted Last updated 14 April 2017

What this trial tests

NA trial testing Motivational Interview in Alcohol Abuse in 439 participants. Completed in 28 January 2015.

Timeline

5 September 2011

Primary endpoint
28 January 2015

28 January 2015

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	439
Start date	5 September 2011
Primary completion	28 January 2015
Estimated completion	28 January 2015
Sites	2 locations across United States

Drugs / interventions tested

• Motivational Interview
• Treatment as Usual

Conditions studied

• Alcohol Abuse — all drugs for Alcohol Abuse →
• Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
• Marijuana Abuse — all drugs for Marijuana Abuse →
• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

Yale University

Who can join

Adults 18 to 60, female only, with Alcohol Abuse or Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Days Per Month of Primary Substance Use Primary · 7 non-overlapping monthly intervals from baseline to month 6

Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.

baseline

Group	Value	95% CI
Motivational Interview-Nurse	23.2	± 8.3
Motivational Interview-Computer	23.7	± 7.7
Treatment as Usual	24.2	± 7.7

Month 1

Group	Value	95% CI
Motivational Interview-Nurse	19.3	± 11.2
Motivational Interview-Computer	19.7	± 11.2
Treatment as Usual	22.8	± 8.9

Month 2

Group	Value	95% CI
Motivational Interview-Nurse	18.7	± 11.8
Motivational Interview-Computer	17.9	± 12.1
Treatment as Usual	22.2	± 10.1

Month 3

Group	Value	95% CI
Motivational Interview-Nurse	18.0	± 12.0
Motivational Interview-Computer	17.8	± 11.9
Treatment as Usual	21.4	± 10.6

Month 4

Group	Value	95% CI
Motivational Interview-Nurse	18.0	± 12.2
Motivational Interview-Computer	16.8	± 12.3
Treatment as Usual	20.0	± 11.4

Month 5

Group	Value	95% CI
Motivational Interview-Nurse	17.6	± 12.5
Motivational Interview-Computer	16.3	± 12.6
Treatment as Usual	19.7	± 11.4

Month 6

Group	Value	95% CI
Motivational Interview-Nurse	17.0	± 12.3
Motivational Interview-Computer	16.2	± 12.5
Treatment as Usual	19.1	± 11.8

Treatment Utilization Primary · baseline to 6 months

Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).

utilized treatment

Group	Value	95% CI
Motivational Interview-Nurse	39
Motivational Interview-Computer	39
Treatment as Usual	43

no tretment

Group	Value	95% CI
Motivational Interview-Nurse	106
Motivational Interview-Computer	104
Treatment as Usual	108

Rates of STDs Secondary · baseline to 6 months

rates of incident std's per patient's medical records

Incident case

Group	Value	95% CI
Motivational Interview-Nurse	8
Motivational Interview-Computer	4
Treatment as Usual	6

Non-incident case

Group	Value	95% CI
Motivational Interview-Nurse	135
Motivational Interview-Computer	138
Treatment as Usual	152

Missing

Group	Value	95% CI
Motivational Interview-Nurse	2
Motivational Interview-Computer	1
Treatment as Usual	3

Mean Cost for Each Intervention Secondary · 6 months

The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs

Group	Value	95% CI
Motivational Interview	57.56	± 16.12
Motivational Interview-Electronic	21.07	± 4.43
Treatment as Usual	21.21	± 7.3

Sponsor's own description

The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women.
   Loree AM, Yonkers KA, Ondersma SJ, Gilstad-Hayden K, et al · · 2019 · cited 14× · PMID 30797381 · DOI 10.1016/j.jsat.2019.01.007
2. Abstinence outcomes among women in reproductive health centers administered clinician or electronic brief interventions.
   Yonkers KA, Dailey JI, Gilstad-Hayden K, Ondersma SJ, et al · · 2020 · cited 6× · PMID 32359666 · DOI 10.1016/j.jsat.2020.02.012
3. The short-term impact on economic outcomes of SBIRT interventions implemented in reproductive health care settings.
   Olmstead TA, Martino S, Ondersma SJ, Gilstad-Hayden K, et al · · 2021 · cited 3× · PMID 33298305 · DOI 10.1016/j.jsat.2020.108179