Positive Affect Treatment for Spanish-Speaking Individuals

Southern Methodist University

Status: Active, not recruiting

Conditions: Depression in Adults; Anhedonia; Anxiety

Treatments: Behavioral: Positive Affect Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07493369

25-093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Positive Affect Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Positive Affect Treatment