Substance Use DisordersBADS-SUDNCT07395700
Validation of the Behavioral Activation for Depression Scale in Individuals With Substance Use Disorders
An observational study of Substance Use Disorders and Mental Health Disorders, run by Lauro Gutiérrez Castro at 1 site in Mexico.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Substance Use Disorders, Mental Health Disorders, Substance-related Disorders
- How many people
- 289 participants
- Where
- 1 siteMexico
- Study dates
- 18 Mar 2024to 22 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Validation of the Behavioral Activation for Depression Scale (BADS) in a Clinical Sample of Individuals With Substance Use Disorders
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.
Read the detailed description
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:
- 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).
- 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.
- Conditions
- Substance Use Disorders, Mental Health Disorders, Substance-related Disorders, Depression Scale Score, Validation Study
- Keywords
- Behavioral Activation, Psychometric Validation, Substance Use Disorders, Addiction, External Validity, Incremental Validity, Clinical Assessment, Behavioral Functioning, Depression, Functional Impairment
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric Validity of the Behavioral Activation for Depression Scale (BADS)
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.
Measured: Baseline (single cross-sectional assessment).
Secondary outcomes (2)
Convergent and Discriminant Validity of the Behavioral Activation for Depression Scale With the Borderline Symptom List-23
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.
Measured: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
Convergent Validity of the Behavioral Activation for Depression Scale With the Environmental Reward Observation Scale
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.
Measured: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start18 Mar 2024
- Primary completion30 Nov 2025
- Study completion22 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauro Gutiérrez Castro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
- Investigators
- Lauro Gutiérrez Castro, Principal investigator, Under The Tree Therapeutic Community
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395700
- Sponsor's protocol ID
- BADS-SUD-VALID-01
- Acronym
- BADS-SUD
- Status last verified
- Nov 2026
- First submitted
- 7 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Behavioral Activation for Depression Scale (BADS) in a Clinical Sample of Individuals With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07395700
- Acronym / sponsor ID
- BADS-SUD / BADS-SUD-VALID-01
- Conditions
- Substance Use Disorders, Mental Health Disorders, Substance-related Disorders, Depression Scale Score, Validation Study
- Keywords
- Behavioral Activation, Psychometric Validation, Substance Use Disorders, Addiction, External Validity, Incremental Validity, Clinical Assessment, Behavioral Functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Lauro Gutiérrez CastroUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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).
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychometric Validity of the Behavioral Activation for Depression Scale (BADS)
Time frame: Baseline (single cross-sectional assessment).
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.
2 secondary outcomes
Convergent and Discriminant Validity of the Behavioral Activation for Depression Scale With the Borderline Symptom List-23
Time frame: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
Convergent Validity of the Behavioral Activation for Depression Scale With the Environmental Reward Observation Scale
Time frame: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauro Gutiérrez Castro principal investigator
Under The Tree Therapeutic Community
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Mental Health Disorders, run by Lauro Gutiérrez Castro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric Validity of the Behavioral Activation for Depression Scale (BADS) (time frame: Baseline (single cross-sectional assessment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.