Southern Methodist University
Dallas, Texas, 75205, United States
NCT Number: NCT07493369
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 and impaired functioning, between the ages of 18 and 65 years. Participants will complete psychiatric assessments and self-report questionnaires as part of the study.
The total length of participation is around 4 months.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75205, United States
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) and one-month follow-up. Feasibility outcomes, such as session attendance, practice completion, and acceptability outcomes, such as satisfaction questionnaire, are assessed at Week 15 (post). Clinical outcomes are assessed at baseline and either weekly or at one-month follow-up.
Target enrollment is 12 participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years. Participants will complete psychiatric assessments and self-report questionnaires as part of the study.
The total length of participation is around 4 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: PAT
Time frame: Post-treatment (after session 15)
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.
Time frame: Post-treatment (after session 15)
12-item questionnaire used to assess the participants' therapeutic alliance ratings along three domains: goal, task, and bond.
Time frame: From enrollment to post-treatment (after session 15)
Treatment attrition will be calculated as the dropout percentage after enrollment.
Time frame: From enrollment to post-treatment (after session 15)
Treatment attendance will be operationalized as the total number of treatment sessions attended out of the 15 planned sessions.
Time frame: From session 2 to post-treatment (after session 15)
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.
Time frame: After session 1
6-item self-report measure, divided into credibility and outcome expectancy questions.
Time frame: From recruitment to enrollment
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.
Time frame: Screening, weekly from session 1-15, and at 1-month follow-up
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.
Time frame: Screening, weekly from session 1-15 and at 1-month follow-up
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.
Time frame: Post-treatment (after session 15)
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.
Time frame: Screening
3-item measure that assesses the severity of distress resulting from impairment in work, family life/home responsibilities, and social/leisure activities.
Time frame: Screening and 1-month follow-up
Structured clinical interview used to assess current (not past) clinical diagnoses. At a 1-month follow-up assessment, the study staff will conduct the SCID-5-RV without the exclusion criteria modules to describe the participants' clinical diagnoses after treatment.
Time frame: Screening and 1-month follow-up
Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia
Time frame: Pre-treatment (before session 1)
12-item self-report questionnaire used to measure stress arising from adapting to a new culture
Time frame: Weekly from session 1-15
Item 9 of the Beck Depression Inventory-II (BDI-II) will be used to assess suicidality before each treatment session. The item is rated on a four-point scale from 0 to 3, with higher scores indicating greater severity.
Southern Methodist University
Other
Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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