Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Affect Treatment | Experimental | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alicia E Meuret, Ph.D. | Southern Methodist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Methodist University | Dallas | Texas | 75205 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 7, 2025 | Mar 20, 2026 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059445 | Anhedonia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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 |
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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |