AnhedoniaNCT07493369
Positive Affect Treatment for Spanish-Speaking Individuals
A study testing Positive Affect Treatment in people with Anhedonia and Depression in Adults, run by Southern Methodist University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anhedonia, Depression in Adults, Anxiety
- What is being tested?
- Positive Affect Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anhedonia, Depression in Adults, Anxiety
- Being tested
- Positive Affect Treatment
- Medical subject headings
- Anhedonia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect TreatmentBehavioural
Also called PAT
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
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Treatment | Experimental | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Receives: Behavioral: Positive Affect Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-treatment (after session 15)
Treatment Attrition
Treatment attrition will be calculated as the dropout percentage after enrollment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening, weekly from session 1-15 and at 1-month follow-up
Secondary outcomes (1)
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.
Measured: Post-treatment (after session 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start20 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Uribe, Southern Methodist University
- Investigators
- Alicia E Meuret, Ph.D., Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493369
- Sponsor's protocol ID
- 25-093
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial
- ClinicalTrials.gov ID
- NCT07493369
- Acronym / sponsor ID
- 25-093
- Conditions
- Anhedonia, Depression in Adults, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Treatment | Experimental | Behavioral: Positive Affect Treatment15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Affect TreatmentAlso: PATSessions 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 | Behavioural | Positive Affect Treatment |
Primary outcome
Client Satisfaction Questionnaire-8 (CSQ-8)
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.
Working Alliance Inventory-Short (WAI-S)
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.
Treatment Attrition
Time frame: From enrollment to post-treatment (after session 15)
Treatment attrition will be calculated as the dropout percentage after enrollment.
Treatment Attendance
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.
Treatment Practice Adherence
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.
Credibility/Expectancy Questionnaire (CEQ)
Time frame: After session 1
6-item self-report measure, divided into credibility and outcome expectancy questions.
Recruitment feasibility
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.
Positive and Negative Affect Scale - Positive Subscale (PANAS-P)
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.
Depression Anxiety Stress Scale- 21 (DASS-21)
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.
1 secondary outcome
Qualitative Feedback
Time frame: Post-treatment (after session 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia E Meuret, Ph.D. principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Treatment in people with Anhedonia and Depression in Adults, run by Southern Methodist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: Post-treatment (after session 15)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.