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Positive Affect Treatment for Spanish-Speaking Individuals 12
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La sperimentazione clinica NCT07493369 è uno studio interventistico per Anedonia, Depression in Adults, Ansia, attualmente attivo, non in arruolamento. Avviato il 20 gennaio 2026, prevede di arruolare 12 partecipanti. Sotto la guida di Southern Methodist University, dovrebbe concludersi entro il 30 giugno 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
The purpose of this study is to evaluate the feasibility and acceptability of Positive Affect Treatment (PAT) in a Spanish-speaking population. PAT is a psychotherapy specifically aimed at enhancing reward sensitivity in individuals with low positive affect (a core feature of anhedonia) in the context of depression or anxiety.
Target enrollment is 12 participants with low positive affect and depression or anxiety an...
Mostra di piùDescrizione dettagliata
As an extension of two prior NIMH funded trials (R61 phase trial and R33 phase randomized controlled trial), the aim of this trial is to evaluate the feasibility and acceptability of PAT in a Spanish-speaking population with low positive affect in the context of depression, anxiety or stress symptoms.
Feasibility, acceptability, and clinical outcomes are assessed at baseline and either weekly or at Week 15 (post) an...
Mostra di piùTitolo ufficiale
Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial
Patologie
AnedoniaDepression in AdultsAnsiaAltri ID dello studio
- 25-093
Numero NCT
Data di inizio (effettiva)
2026-01-20
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2026-06-30
Arruolamento (previsto)
12
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentalePositive Affect Treatment 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. | trattamento dell'affetto positivo Sessions 1-7: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects (continued for sessions 8-15) Sessions 8-10: Cognitive exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Client Satisfaction Questionnaire-8 (CSQ-8) | 8-item self-report measure used to capture satisfaction with services. Each item is scored on a four-point scale from 1 to 4, with a total score range from 8 to 32. Higher scores suggest greater satisfaction with the treatment. | Post-treatment (after session 15) |
Working Alliance Inventory-Short (WAI-S) | 12-item questionnaire used to assess the participants' therapeutic alliance ratings along three domains: goal, task, and bond. | Post-treatment (after session 15) |
Treatment Attrition | Treatment attrition will be calculated as the dropout percentage after enrollment. | From enrollment to post-treatment (after session 15) |
Treatment Attendance | Treatment attendance will be operationalized as the total number of treatment sessions attended out of the 15 planned sessions. | From enrollment to post-treatment (after session 15) |
Treatment Practice Adherence | After each treatment session, the participant's practice completion (e.g., pleasant activities, savoring exercises) will be measured using a 0-100% scale, with 0% indicating that they did not complete any practice outside of therapy sessions, and 100% indicating that they completed all scheduled practice. Overall practice completion will be calculated as the average of practice outside of sessions completed across 14 sessions, since no homework will be assigned for the first session. | From session 2 to post-treatment (after session 15) |
Credibility/Expectancy Questionnaire (CEQ) | 6-item self-report measure, divided into credibility and outcome expectancy questions. | After session 1 |
Recruitment feasibility | Feasibility of recruitment will be examined using three parameters: number of individuals screened per month, number of participants enrolled per month, and average time from screening to enrollment including the reason for any long delays. In addition, the reason for lack of enrollment (e.g., not eligible, not interested, lost to follow-up) will be recorded. | From recruitment to enrollment |
Positive and Negative Affect Scale - Positive Subscale (PANAS-P) | Self-report measure of positive affect. The scale includes 20 items, 10 indicating positive affect (e.g., excited) and 10 corresponding to negative affect (e.g., scared). Each item is rated on a five-point scale, with higher scores indicating a higher level of positive or negative affect. | Screening, weekly from session 1-15, and at 1-month follow-up |
Depression Anxiety Stress Scale- 21 (DASS-21) | 21-item self-report measure of symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency. | Screening, weekly from session 1-15 and at 1-month follow-up |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Qualitative Feedback | Participants will complete written open-ended items in Spanish asking about (1) treatment feasibility, (2) treatment acceptability, (3) treatment satisfaction, (4) treatment comprehension, (5) perceived effectiveness, (6) suggestions, and (7) other general comments. | Post-treatment (after session 15) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Spanish as their preferred language for therapy
- Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression, greater to or equal to 6 for anxiety, or greater to or equal to 10 for stress on the Depression, Anxiety, and Stress Scale; and scores of greater than or equal to 5 on any Sheehan Disability Scale subscale.
- Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion
- Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes)
- Active suicidal ideation
- Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage
- Substance abuse in the last 6 months or dependence within last 12 months.
- Greater than 11 cigarettes per week or nicotine equivalent before age 15
- History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine)
- Pregnancy
- Bupropion, dopaminergic or neuroleptic medications use in the past 6 months
- Refusal of video/audio-taping
- Prior participation in previous waves of this study
Southern Methodist UniversityParte responsabile dello studio
Sofia Uribe, Investigatore principale, Clinical Psychology Graduate Student, Southern Methodist University
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Texas
Southern Methodist University, Dallas, Texas, 75205, United States