- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07395700
Validering av beteendeaktiveringsskalan för depression hos individer med substansbruksstörningar (BADS-SUD)
Psykometrisk validering av Behavioral Activation for Depression Scale (BADS) i ett kliniskt urval av individer med substansbruksstörningar
This cross-sectional observational study evaluates the psychometric properties, structural validity, item response characteristics, and concurrent criterion validity of the Behavioral Activation for Depression Scale (BADS) in adults receiving clinical treatment for substance use disorders (SUD). The study examines the scale's dimensional structure, reliability, and association with environmental reward (Environmental Reward Observation Scale, EROS) in a primary clinical cohort of 289 participants. Concurrent and discriminant validity analyses with additional clinical measures (assessing borderline symptom severity, impulsivity, anxiety, and anger expression) were evaluated in a verified sequential subcohort of 59 participants with fully confirmed individual-level linkage across multi-scale administration sheets. This retrospective study record documents the completed psychometric evaluation conducted within a specialized residential therapeutic community.
Studieöversikt
Status
Detaljerad beskrivning
This study employs a cross-sectional observational design to evaluate the psychometric properties and dimensional structure of the Spanish version of the Behavioral Activation for Depression Scale (BADS) in individuals receiving residential or intensive clinical treatment for substance use disorders. The completed validation protocol comprises two complementary analytic components:
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Primary Cohort Analyses (N = 289):
Analyses of internal structure, categorical confirmatory factor analysis (using WLSMV estimation on polychoric correlations), exploratory structural equation modeling (ESEM), bifactor modeling, item response theory (Samejima's Graded Response Model), and internal consistency reliability were conducted in a primary clinical sample of 289 adult patients. Item completeness reached 99.7% across the 25 BADS items (288 complete records, 1 record with six items omitted). Concurrent criterion validity with perceived environmental reward was examined across this entire cohort using the Environmental Reward Observation Scale (EROS).
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Secondary Multi-Scale Clinical Analyses (Verified n = 59):
Concurrent and discriminant relationships with external clinical constructs-including borderline symptom severity (BSL-23), impulsivity (BIS-11), generalized anxiety (GAD-7), and anger expression (STAXI-2)-were evaluated. Although 155 multi-scale records were captured during clinical testing and earlier study drafts described an analytic target of 127 participants, retrospective quality control revealed an unindexed row offset in spreadsheet transcriptions beginning at record 60. To maintain strict scientific integrity and avoid mispairing, concurrent multi-battery analyses are reported exclusively on the initial sequential subcohort of 59 participants whose individual identity, sex, age, and questionnaire administration sequence are verified at 100%. Remaining captured records remain designated as pending verification against institutional physical charts.
This record reflects the retrospective documentation and post-completion reconciliation of the completed study protocol.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Jalisco
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Ajijic, Jalisco, Mexiko, 45920
- Comunidad Terapéutica Under The Tree
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
The study population consists of adults receiving residential treatment for substance use disorders in a therapeutic community setting. Participants represent a clinically relevant population characterized by difficulties in mood regulation, behavioral activation, emotional dysregulation, and related psychological symptoms commonly associated with substance use disorders.
Beskrivning
Inclusion Criteria:
- Adults aged 18 to 68 years.
- Primary clinical diagnosis of Substance Use Disorder (evaluated in accordance with DSM-5 criteria) currently receiving residential or intensive clinical treatment in a therapeutic community setting.
- Literacy and fluency in Spanish sufficient to complete self-report instruments.
- Provision of voluntary written informed consent.
- Completion of the Behavioral Activation for Depression Scale (BADS).
Exclusion Criteria:
- Severe cognitive impairment, active psychosis, or acute neurological conditions precluding accurate self-reporting.
- Active substance intoxication or acute withdrawal symptoms at the time of testing that interfere with questionnaire completion.
- Substantial missing data preventing psychometric modeling (participants with at least 75% item completion on the primary instrument were retained for categorical estimation under pairwise/FIML algorithms).
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Psychometric Validity of the Behavioral Activation for Depression Scale (BADS)
Tidsram: Baseline (single cross-sectional assessment).
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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 and/or 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. |
Baseline (single cross-sectional assessment).
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Convergent and Discriminant Validity of the Behavioral Activation for Depression Scale With the Borderline Symptom List-23
Tidsram: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
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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. |
Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
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Convergent Validity of the Behavioral Activation for Depression Scale With the Environmental Reward Observation Scale
Tidsram: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
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Convergent validity of the Behavioral Activation for Depression Scale (BADS) will be evaluated through its association with the Environmental Reward Observation Scale (EROS), a self-report measure assessing perceived availability and frequency of environmental positive reinforcement. The EROS consists of 10 items scored on a 4-point Likert-type scale (1 = strongly disagree to 4 = strongly agree), yielding total scores ranging from 10 to 40, with higher scores indicating greater perceived availability of environmental positive reinforcement. Correlations between BADS subscale and total scores and EROS scores will be analyzed as continuous variables across the primary clinical cohort (N = 289) to examine the theoretical correspondence between behavioral activation processes and perceived environmental reinforcement in a residential substance use treatment setting. |
Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BADS-SUD-VALID-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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