- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07395700
약물 사용 장애 환자에서의 우울증 행동 활성화 척도의 타당성 검증 (BADS-SUD)
약물 사용 장애 임상 표본에서 우울증 행동 활성화 척도(BADS)의 심리측정적 타당성 검증
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Jalisco
-
Ajijic, Jalisco, 멕시코, 45920
- Comunidad Terapéutica Under The Tree
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Psychometric Validity of the Behavioral Activation for Depression Scale (BADS)
기간: 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. |
Baseline (single cross-sectional assessment).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Convergent and Discriminant Validity of the Behavioral Activation for Depression Scale With the Borderline Symptom List-23
기간: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
|
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.
|
|
Convergent Validity of the Behavioral Activation for Depression Scale With the Environmental Reward Observation Scale
기간: Single cross-sectional assessment conducted at the time of psychological evaluation during residential treatment.
|
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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .