Positive Affect Treatment for Spanish-Speaking Individuals

NCT07493369 | Active Not Recruiting

• 1 other identifier: 25-093
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anhedonia; Depression in Adults; Anxiety

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Qualitative Feedback

  Post-treatment (after session 15)

Other Outcomes (5)

• Sheehan Disability Scale (SDS)

  Screening

• Structured Clinical Interview for DSM-5 - Research Version (SCID-5-RV)

  Screening and 1-month follow-up

• Interviewer Anhedonia Ratings

  Screening and 1-month follow-up

Study Arms (1)

Positive Affect Treatment

EXPERIMENTAL

15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

Behavioral: Positive Affect Treatment

Interventions

Positive Affect Treatment BEHAVIORAL

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

Also known as: PAT

Positive Affect Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75205, United States

Location

MeSH Terms

Conditions

Anhedonia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Alicia E Meuret, Ph.D.

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychology Graduate Student

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)