Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Credibility/Expectancy Questionnaire (CEQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Credibility/Expectancy Questionnaire (CEQ)
时间窗: After session 1
6-item self-report measure, divided into credibility and outcome expectancy questions.
Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: 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)
时间窗: 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
时间窗: From enrollment to post-treatment (after session 15)
Treatment attrition will be calculated as the dropout percentage after enrollment.
Treatment Attendance
时间窗: 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
时间窗: 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.
Recruitment feasibility
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Qualitative Feedback(Post-treatment (after session 15))
研究者
Sofia Uribe
Clinical Psychology Graduate Student
Southern Methodist University