Ultra-brief Psychological Treatments for Emocional Symptoms and Disorders: An Efficacy and Efficiency Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which variables of cognition and of the intervention process itself are involved in the therapeutic improvement.
The investigators will compare the interventions of four groups: brief group treatment (1), ultra-brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group.
The main questions the study aims to answer are:
- Will the brief and ultra-brief treatment formats works better than the relaxation-based control group?
- Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar?
- Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance?
- Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •- Patients presenting negative emotional symptomatology (anxiety, depression or somatizations), mild or moderate. Specifically, they will be included in the study if they present a score ≥ 5 on the PHQ-9, the GAD-7 or the PHQ-15.
排除标准
- •Bipolar disorder, personality disorder, psychosis or substance abuse, indicated by SCID-5-CV
- •Recent suicide attempt.
- •Severe emotional symptoms (PHQ-15 or GAD-7 ≥ 15; or PHQ-9 ≥ 20).
研究组 & 干预措施
Group 1: Group brief TD-CBT
干预措施: Group brief transdiagnostic cognitive-behavioral therapy (Behavioral)
Group 2: Group ultra-brief TD-CBT
干预措施: Group ultra-brief transdiagnostic cognitive-behavioral therapy (Behavioral)
Group 3: Individual ultra-brief TD-CBT
干预措施: Individual ultra-brief transdiagnostic cognitive-behavioral treatment format (Behavioral)
Group 4: relaxation
干预措施: Group relaxation (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
The PHQ-9 is the depression module of the PHQ, that scores the 9 DSM-IV depression criteria present in the last two weeks from 0 ("not at all") to 3 ("nearly every day"). A score of 10 is usually set as the cut-off point for major depression disorder (MDD): a score of 10-14 indicates minor depression, moderate MDD, or dysthymia; 15-19, moderately severe MDD; and 20-27, severe MDD. This tool has been tested in Spanish primary care centres (McDonald's ω = .89).
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
The GAD-7 assesses common anxiety symptoms in the last two weeks, scoring from 0 ("not at all") to 3 ("nearly every day"). Cut points of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. The algorithm sets 8 as the cut point for GAD, however it has been found that a score of 10 is more optimal. We will use a version validated in Spanish, that was recently tested in primary care centres (Cronbach's α = .83).
Patient Health Questionnaire-15 (PHQ-15)
时间窗: Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months)
The PHQ-15 is the somatization module of the PHQ. It includes 13 somatic symptoms plus 2 from the PHQ-9 (sleeping problems and fatigue). Scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity, respectively. To screen a somatization disorder, whereas the original algorithm needs of at least a score of 2 in three or more somatic symptoms (sensitivity of 78% and specificity of 71%), the cut point usually used is 10; nevertheless, since this can be obtained with ten symptoms of mild severity, we decided to join both criteria to screen the disorder. Furthermore, an absence of biological cause is also often required (since PHQ-15 does not distinguish between medically explained and unexplained symptoms), but the self-administered nature of the PHQ-15 makes difficult to determine this. The PHQ-15 has been validated with Spanish psychiatric outpatients (α = .78).
Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV)
时间窗: Baseline and post-treatment (two weeks after the end of treatment).
Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV), is an interview commonly used to diagnose mental disorders according to the DSM-5 criteria. It is administered by a clinician or trained mental heatlh professional who is familiar with the DSM-5 classification and diagnostic criteria. We will use only the diagnostic criteria to evaluate the existence or not of Major Depressive Episode, Generalized Anxiety Disorder and to exclude the existence of other disorders such as Bipolar Disorder, psychotic disorders, substance use and personality disorder.
次要结局
- Cognitive Emotional Regulation Questionnaire (CERQ-27)(Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months))
- Common Factor Scale (MPOQ)(Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).)
- Working Alliance Inventory-Short Form Patient version (WAI-S-P)(Peritreatment: weeks 1 and 3 (for 4-session groups); weeks 1 and 7 (for the 8-session group).)
- Psychological Outcome Profiles (PSYCHLOPS)(Baseline and post-treatment (two weeks after the end of treatment).)
- Satisfaction with therapy(Post-treatment (two weeks after the end of treatment).)
- Sociodemographic data(Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months))
- Healthcare use questions(Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months))
- Acceptance and Action Questionnaire (AAQ-II)(Baseline, post-treatment (two weeks after the end of treatment), and follow-ups (3 and 6 months))
研究者
Juan A. Moriana
Professor
Universidad de Córdoba
