Positive Affect Treatment for Spanish-Speaking Individuals

Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anhedonia; Anxiety; Depression in Adults
• Intervention / Treatment: Behavioral: Positive Affect Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75205
      • Southern Methodist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Positive Affect Treatment; 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

Behavioral: Positive Affect Treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sheehan Disability Scale (SDS)	3-item measure that assesses the severity of distress resulting from impairment in work, family life/home responsibilities, and social/leisure activities.	Screening
Structured Clinical Interview for DSM-5 - Research Version (SCID-5-RV)	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.	Screening and 1-month follow-up
Interviewer Anhedonia Ratings	Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia	Screening and 1-month follow-up
Riverside Acculturation Stress Inventory	12-item self-report questionnaire used to measure stress arising from adapting to a new culture	Pre-treatment (before session 1)
Beck Scale for Suicide Ideation	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.	Weekly from session 1-15

Collaborators and Investigators

• Sponsor: Southern Methodist University
• Investigators: Principal Investigator: Alicia E Meuret, Ph.D., Southern Methodist University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Anhedonia
• Other Study ID Numbers: 25-093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No