Positive Affect Treatment for Spanish-Speaking Individuals

N/AActive Not RecruitingNCT07493369

Southern Methodist University12 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Positive Affect TreatmentBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Post-treatment (after session 15)

Treatment Attrition

Treatment attrition will be calculated as the dropout percentage after enrollment.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Screening, weekly from session 1-15 and at 1-month follow-up

Secondary Outcomes

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.

Time frame: Post-treatment (after session 15)

Positive Affect Treatment for Spanish-Speaking Individuals

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes