- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395700
Validation of the Behavioral Activation for Depression Scale in Individuals With Substance Use Disorders (BADS-SUD)
Psychometric Validation of the Behavioral Activation for Depression Scale (BADS) in a Clinical Sample of Individuals With Substance Use Disorders
Study Overview
Status
Detailed Description
This study employs a cross-sectional observational design to evaluate the psychometric performance of the Behavioral Activation for Depression Scale (BADS) in individuals with substance use disorders. The validation process consisted of two complementary analytic components based on data availability.
First, analyses of internal structure, reliability, and item-level performance were conducted using data from 289 participants who completed the BADS. These analyses included advanced psychometric methods to evaluate the dimensional structure and measurement properties of the scale.
Second, external and incremental validity analyses were conducted in a subsample of 127 participants for whom complete data were available on additional validated self-report measures assessing clinically relevant constructs, including symptom severity, anxiety, impulsivity, and anger expression. This subsample approach reflects the naturalistic data collection process in clinical settings and allowed for the examination of the BADS' relationships with external criteria without imputing missing data.
Together, these analyses provide a comprehensive evaluation of the BADS, integrating evidence from internal psychometric validation and external criterion-related validity in a clinical population with substance use disorders.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jalisco
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Ajijic, Jalisco, Mexico, 45920
- Comunidad Terapéutica Under The Tree
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Currently receiving treatment or undergoing clinical evaluation for substance use disorders in a therapeutic or clinical setting.
- Ability to read and understand Spanish.
- Ability to provide informed consent.
- Completion of the Behavioral Activation for Depression Scale and at least one additional study questionnaire.
Exclusion Criteria:
- Severe cognitive impairment or acute psychiatric symptoms that prevent accurate self-reporting.
- Incomplete or missing data on key study measures.
- Current intoxication or acute withdrawal symptoms at the time of assessment that interfere with completing questionnaires.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Individuals With Substance Use Disorders
Single clinical group composed of adults receiving treatment for substance use disorders who completed the Behavioral Activation for Depression Scale (BADS) and additional self-report measures as part of a cross-sectional observational study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Psychometric Validity of the Behavioral Activation for Depression Scale (BADS)
Time Frame: Baseline, pre-intervention (single cross-sectional assessment at study enrollment)
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Psychometric properties of the Behavioral Activation for Depression Scale (BADS), including internal structure (confirmatory factor analysis), internal consistency reliability (Cronbach's alpha / omega), and construct validity (convergent and discriminant validity), assessed using self-report data collected at a single time point in individuals with substance use disorders.
Subscale scores will also be examined, with higher scores reflecting greater expression of the respective behavioral domains.
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Baseline, pre-intervention (single cross-sectional assessment at study enrollment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Convergent and Discriminant Validity of the Behavioral Activation for Depression Scale With the Borderline Symptom List-23
Time Frame: Baseline, pre-intervention (single cross-sectional assessment conducted at study enrollment)
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Convergent and discriminant validity of the Behavioral Activation for Depression Scale will be examined through its association with scores on the Borderline Symptom List-23, a self-report measure of borderline symptom severity and behavioral dysregulation.
The Borderline Symptom List-23 provides a mean total score ranging from 0 to 4, with higher scores indicating greater severity of borderline symptomatology.
Associations will be analyzed using continuous scores to evaluate the extent to which behavioral activation and avoidance patterns measured by the Behavioral Activation for Depression Scale relate to clinical severity and emotional dysregulation in individuals with substance use disorders.
The Borderline Symptom List-23 is a 23-item self-report scale scored on a 5-point Likert-type format (0 to 4), producing a mean total score ranging from 0 to 4. Higher scores indicate greater severity of borderline symptomatology and emotional dysregulation.
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Baseline, pre-intervention (single cross-sectional assessment conducted at study enrollment)
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Convergent Validity of the Behavioral Activation for Depression Scale With the Environmental Reward Observation Scale
Time Frame: Baseline, pre-intervention (single cross-sectional assessment at study enrollment)
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Convergent validity of the Behavioral Activation for Depression Scale will be evaluated through its association with the Environmental Reward Observation Scale, a self-report measure assessing perceived availability and frequency of environmental positive reinforcement.
The Environmental Reward Observation Scale consists of 10 items scored on a Likert-type scale, with higher total scores reflecting greater perceived environmental reinforcement.
Correlations between Behavioral Activation for Depression Scale scores and Environmental Reward Observation Scale scores will be analyzed as continuous variables to examine the theoretical correspondence between behavioral activation processes and perceived environmental reinforcement in a residential substance use treatment context.
The Environmental Reward Observation Scale consists of 10 items scored on a 4-point Likert-type scale, yielding total scores ranging from 10 to 40, with higher scores indicating greater perceived availability of en
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Baseline, pre-intervention (single cross-sectional assessment at study enrollment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BADS-SUD-VALID-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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