- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139643
Assessment of the Predictors and Moderators of Behavior Change (ABC)
May 25, 2018 updated by: Michael Otto, Boston University Charles River Campus
The current study aims to investigate two potential interventions (i.e., cognitive dissonance and action planning) for inducing behavior change for behaviors important to college students-studying and exercise.
In addition, this study will investigate factors that may impact behavior change, such as psychological and neuropsychological variables, to better understand how to bridge the intention-behavior gap.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Boston University Psychology 101 students at least 18 years of age
- Able to provide informed consent for the study
- Sufficient command of the English language
- Have experience using a computer and mouse
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Dissonance
After reading the materials about their chosen behavior, participants will be asked write an essay about their behavior of choice (studying/exercising).
For this essay they will be asked to imagine that they have reached their ideal level of academic achievement/fitness, describe what this would look and feel like, and reflect on how this would impact how they view themselves, their relationships, and their day to day life.
|
After reading the materials about their chosen behavior, participants will be asked write an essay about their behavior of choice (studying/exercising).
For this essay they will be asked to imagine that they have reached their ideal level of academic achievement/fitness, describe what this would look and feel like, and reflect on how this would impact how they view themselves, their relationships, and their day to day life.
|
|
Experimental: Action Planning
After reading the materials about their chosen behavior, participants will be asked to make a detailed plan for the following two weeks based on the following items taken from a study by Sniehotta and colleagues (2004): 1) when to complete studying/exercise, 2) where to complete studying/exercise, 3) how to complete studying/exercise (e.g., what types of exercise- cardio, class, etc. or what types of studying activities- reading, taking notes, creating outlines, etc.), and 4) how often to complete studying/exercise.
Participants will be given a calendar as an aid to planning their behavior.
|
After reading the materials about their chosen behavior, participants will be asked to make a detailed plan for the following two weeks based on the following items taken from a study by Sniehotta and colleagues (2004): 1) when to complete studying/exercise, 2) where to complete studying/exercise, 3) how to complete studying/exercise (e.g., what types of exercise- cardio, class, etc. or what types of studying activities- reading, taking notes, creating outlines, etc.), and 4) how often to complete studying/exercise.
Participants will be given a calendar as an aid to planning their behavior.
|
|
Placebo Comparator: Reflection (Control Condition)
After reading the materials about their chosen behavior, participants will be asked to summarize and reflect on what they read.
|
After reading the materials about their chosen behavior, participants will be asked to summarize and reflect on what they read.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Physical Activity Questionnaire
Time Frame: Change from baseline to 4 weeks
|
Participants who choose to change their exercising behavior will be administer only this outcome measure; therefore, all participants only complete 1 primary outcome measure.
|
Change from baseline to 4 weeks
|
|
Studying Questionnaire
Time Frame: Change from baseline to 4 weeks
|
Participants who choose to change their studying behavior will be administered only this outcome measure; therefore, all participants only complete 1 primary outcome measure.
|
Change from baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distress Intolerance Index
Time Frame: Change from baseline to 4 weeks
|
Measure of distress intolerance.
|
Change from baseline to 4 weeks
|
|
UPPS Impulsive Behavior Scale (UPPS)
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of impulsivity.
|
Change from baseline to 4 weeks
|
|
Penn State Worry Questionnaire (PSWQ)
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of worry.
|
Change from baseline to 4 weeks
|
|
Self-Control Scale (SCS)
Time Frame: Change from baseline to 4 weeks
|
Perceived self-control measure.
|
Change from baseline to 4 weeks
|
|
Delay Discounting Questionnaire
Time Frame: Change from baseline to 4 weeks
|
Monetary choice task.
|
Change from baseline to 4 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of sleep quality for the past month.
|
Change from baseline to 4 weeks
|
|
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of depressive symptoms.
|
Change from baseline to 4 weeks
|
|
Beck Anxiety Inventory (BAI)
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of anxiety symptoms experienced in past week.
|
Change from baseline to 4 weeks
|
|
Generalized Self-Efficacy Scale
Time Frame: Change from baseline to 4 weeks
|
Self-report measure of perceived self-efficacy.
|
Change from baseline to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
May 1, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
May 29, 2018
Last Update Submitted That Met QC Criteria
May 25, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 3555E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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