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临床试验/NCT04847310
NCT04847310Unknown不适用

Cost-effectiveness and Cost-Utility Evaluation of the Individual vs. Group Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)

Universidad de Córdoba6 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
128
试验地点
6
主要终点
Change in panic symptoms: Patient Health Questionnaire-Panic Disorder (PHQ-PD)

研究概览

简要总结

The aim of this study is to compare, in cost-effectiveness and cost-utility terms, a brief transdiagnostic cognitive-behavioural therapy in two different modes, individual and group, with the treatment usually administered in primary care (TAU).

Participants between 18 and 65 years old and with, according to the pretreatment evaluation, mild to moderate emotional disorders will be randomly allocated to the three clusters. They will be assessed again immediately after treatment and 6 and 12 months later.

The study hypotheses expect to find (H1) the individual treatment generally as effective as the group one, whereas (H2) the TAU will be the least effective. (H3) The group therapy is expected to get the best results in terms of cost-effectiveness and (H4) the TAU will get the worst cost-effectiveness results. Furthermore, (H5) it is expected to find these results across the follow-up assessments too.

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 (Outcomes Assessor)

盲法说明

Outcomes assessors will be blinded during pre- and post-treatment. Participants will be blinded during pretreatment assessment; however, it cannot be guaranteed that they will keep blinded in post-treatment.

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

入选标准

  • Mild/moderate emotional disorder

排除标准

  • Severe mental disorder (including severe depressive or anxiety disorders, not somatizations)
  • High level of impairment
  • Recent, severe suicide attempt
  • No emotional disorder/Below the instruments cut-off points

结局指标

主要结局

Change in panic symptoms: Patient Health Questionnaire-Panic Disorder (PHQ-PD)

时间窗: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

The PHQ-PD is the specific panic disorder module of the PHQ and scores each DSM-IV criterion as "yes" or "no" (Wittkampf et al., 2011). Muñoz-Navarro et al. (2016) tested it in Spanish primary care settings and modified the original algorithm to increase the sensitivity for PD diagnosis: the most optimal cut-off point for screening purposes was 5 (the first item \[for panic screening\] and one of the following three, plus four somatic symptoms) (sensitivity of 77% and specificity of 72%).

Change in somatoform symptoms: 15-item Patient Health Questionnaire (PHQ-15)

时间窗: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

The PHQ-15 (Kroenke et al., 2002) 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%) (van Ravesteijn et al., 2009), 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) (Kroenke et al., 2002), 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) (Ros et al., 2010).

Change in depression symptoms: 9-item Patient Health Questionnaire (PHQ-9)

时间窗: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

The PHQ-9 (Kroenke et al., 2001) is the depression module of the PHQ (Díez-Quevedo et al., 2001; Spitzer et al., 1999), 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) (Muñoz-Navarro, Cano-Vindel, Medrano et al., 2017), finding 12 as the best cut point for MDD diagnosis (sensitivity of 84% and specificity of 78%) compared with 10 (sensitivity of 95% and specificity of 67%).

Change in anxiety symptoms: 7-item General Anxiety Disorder scale (GAD-7)

时间窗: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

The GAD-7 (Spitzer et al., 2006) 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 (Spitzer et al., 2006). We will use the version validated by García-Campayo et al. (2010), that was recently tested in primary care centres (Cronbach's α = .83) (Muñoz-Navarro, Cano-Vindel, Moriana et al., 2017), confirming the score of 10 as the best diagnostic criterion (sensitivity of 87% and specificity of 78%).

次要结局

  • Change in the level of impairment: Sheehan Disability Scale (SDS)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Change in general quality of life: World Health Organization Quality of Life Instrument-Brief version (WHOQOL-BREF)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Change in worry: Penn State Worry Questionnaire (PSWQ)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Change in ruminative responses: Ruminative Responses Scale (RRS)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Cost and utility data(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Change in emotion regulation strategies: Cognitive Emotion Regulation Questionnaire (CERQ)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Presence of eating disorders or alcohol abuse (exclusion criterion)(Pre-intervention (screening))
  • Change in attentional and interpretational biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA) and Questionnaire of Cognitive Distortions in Emotional Disorders (CDTE)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Change in metacognitions: 30-item Metacognitions Questionnaire (MCQ-30)(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))
  • Sociodemographic and medical data, and treatment satisfaction(Baseline, immediately after the intervention, and follow-ups (6 and 12 months))

研究者

发起方
Universidad de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Aguilera Martín

Investigator

Universidad de Córdoba

研究点 (6)

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