Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05167097 |
| Other study ID # |
Mindset BI Replication 2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2021 |
| Est. completion date |
March 2, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Konstanz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Brief Interventions (BI) based on Motivational Interviewing are effective in reducing alcohol
use. In this study, the investigators test the hypothesis that mindsets increase the positive
effects of BI among a student sample of risky drinkers.
Subjects will be students with risky alcohol use as identified by the AUDIT. All participants
receive the World Health Organization's (WHO) ASSIST-linked BI in one of two forms. Either
with or without a decisional balance element (Steps 6-9 from the ten steps of the
intervention). Before the ASSIST-linked BI, participants are randomly assigned to one of
three mindset conditions. They either deliberate upon an unsolved problem (deliberative
mindset), plan the implementation of a set goal (implemental mindset), or perform a control
task (control condition).
The investigators measure the change in alcohol-related risk perceptions, treatment
motivation, and alcohol drinking as assessed via the timeline follow-back method. The
investigators also assess THC consumption during the study.
Description:
In this study, the investigators will try to advance our understanding of the effects of
mindset inductions for coping with motivational interventions in hazardously drinking
students. In an earlier study, the investigators found an interactive effect of implemental
mindsets with motivational interviewing on actual risk behavior but not risk perception. The
investigators will target potential underlying processes (e.g., resistance to change,
commitment), as well as compensation and generalization effects by including the assessment
of consumption of alternative risky substances.
The investigators target consumption-related risks and address interactions between mindsets
and motivational interviewing. Combining a mindset induction with a Screening and Brief
Intervention tool in which the risk status of the individual was assessed, and the
interventionist provided feedback, conducted a decisional balance exercise, and used
techniques from motivational interviewing, the investigators found effects on risk taking but
not risk perception. Neither general risk taking in the subscales of the Domain-Specific
Risk-Taking Scale nor alcohol-related risk perception in a specific questionnaire was
significantly affected by our manipulations. Still, participants in an implemental mindset
managed to reduce their monthly alcohol consumption on average by about 7 to 8 standard units
(equates to roughly five glasses of wine) while participants in a deliberative mindset
actually increased their alcohol consumption by a similar amount. The investigators want to
replicate the earlier findings while simultaneously enriching our research design with a) a
control condition to test whether the implemental mindset decreased drinking, the
deliberative mindset increased drinking, or both happened concurrently, b) test for
compensation and/or generalization effects by including the assessment of another substance,
namely Tetrahydrocannabinol (THC), to see if participants may compensate their reduced
alcohol consumption by enhanced consumption of substitutes or if they can self-regulate the
consumption of both, and c) to test whether the decisional balance element of the
ASSIST-linked brief intervention is driving the differences between mindsets.
Design. The experiment follows a 3 between (Mindset: deliberative vs. implemental vs.
control) x 2 between (Brief Intervention: short-form [without decisional balance] vs.
long-form [with decisional balance]) factorial experimental design. Main dependent variables
are the Timeline Followback (TLFB)-based self-reports of substance consumption,
alcohol-related risk perception, and moderating/mediating variables related to the brief
intervention itself (e.g., commitment, openness, resistance to change).
Hypotheses. In the control condition, the investigators expect to see similar results to
earlier work on the effectiveness of motivational interviewing in reducing alcohol. In the
deliberative and implemental mindset condition, however, the investigators expect to see a
more nuanced picture, similar to our previous experiment. To better disentangle this, the
investigators will include specific resistance and commitment ratings during the brief
intervention session after the personalized feedback and after the decisional balance
exercise that follows, the two subsequent parts of the brief intervention. The investigators
hypothesize that deliberative mindset participants would show low resistance during
personalized feedback but high resistance after the decisional balance exercise, and the
opposite pattern for commitment. Implemental mindset participants, on the other hand, are
expected to show the opposite pattern for resistance and commitment after the decisional
balance exercise; it remains unclear, however, how this group will respond to the
personalized feedback procedure. Furthermore, the investigators want to explore whether the
reduction/increase in consumption is specific to the one substance that is addressed in the
brief intervention or whether regulation of consumption also affects alternative substances
in terms of generalization or compensation. The investigators use THC as a model substitute
because of the high prevalence (e.g., 64% in an earlier study.
Procedure. The procedure will be very similar to our previous experiment. Participants will
first be screened using an online questionnaire, and only at-risk drinking individuals (as
indicated by the AUDIT) will be invited to the first lab session. Participants then receive
the mindset manipulation. The investigators will ensure that the interventionist will be
blind to the participants' mindset condition and that the mindset manipulation will involve a
problem or project that is not related to substance use. Thereafter, the interventionist will
assess the individuals' risk behavior regarding a set of substances (using the WHO's ASSIST
manual) in an interview setting and will give the participants individualized feedback on
their consumption (i.e., the first phase of the brief intervention). The interventionist will
then conduct a motivational interview about the participants' personal alcohol consumption
(i.e., the second phase of the brief intervention). Afterward, the interventionist will rate
how resistant the participants behaved during the intervention. Thereafter participants
report their alcohol and THC consumption for the last four weeks using the TLFB and fill out
a series of questionnaires. Four weeks later, participants are back for a second lab session
in which they again fill out the same battery of questionnaires to assess their
(alcohol-specific) risk perception and to assess their alcohol and THC consumption, again
using the TLFB.
