A Pilot Study to Treat Emotional Disorders in Primary Care With Evidence-based Psychological Techniques: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,126
- 试验地点
- 1
- 主要终点
- Somatic symptoms after psychological treatment versus Primary Care usual treatment.
研究概览
简要总结
The strong demand for primary care (PC) services in Spain exceeds resources. Part of this demand is due to the increasing number of anxiety, depression, and somatization disorders that affect the general population. These disorders, commonly known as emotional disorders, are very common in Spanish PC settings, they are poorly detected by physicians, rarely receive adequate treatment (if they receive treatment it is mostly drugs instead of psychological treatment), they generate a highly frequent use of PC services, a greater burden than physical diseases and tend to become chronic without treatment.
Other countries have successfully put psychological techniques in PC into practice (in the United Kingdom the program known as "Improving Access to Psychological Therapies" has obtained very positive results) in order to correctly diagnose and treat emotional disorders. The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better than the usual treatment offered in PC services, involving no side effects, fewer relapses, and lower costs in the long term.
The general aim of this study is to test how well a psychological treatment program for anxiety, depression, and somatization disorders works in PC and to compare the results obtained after seven 90-minute group sessions (every to two to four weeks approximately, for a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar results to the ones already obtained in other countries are expected to be found.
Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression and/or somatization disorder (diagnosed with a simple and short questionnaire) will participate in this study.
Participation will be voluntary and confidentiality will be guaranteed. Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment, within the same health care centre. Since it is a "double-blind" study, neither the health professional nor the patient will know which treatment will be applied. Psychological assessments will be carried out before and after receiving treatment and participants will be followed up at 3, 6 and 12 months.
Participation will pose no risks different from the typically present when receiving usual treatment. The aim of this study will be to maximize benefits and reduce potential harms (principle of proportionality).
详细描述
Secondary objectives:
- The experimental in comparison with the control group will report a greater decrease (including pre-post-treatment differences and follow-up at 3, 6 and 12 months) in emotional symptoms (total scores of anxiety, depressive and somatic symptoms as measured by the Patient Health Questionnaire), cognitive factors, and percentage of cases with probable emotional disorders (anxiety, depression, and somatization disorders).
- The experimental in comparison with the control group will report a decrease in its levels of work, family and social impairment (Sheehan Disability Scale), and an increase in its levels of physical health, psychological, social, and environmental quality of life (as measured by the different World Health Organization Quality of Life; WHOQOL-BREF scales).
- The experimental group in comparison with the control group will reduce the frequency of Primary Care visits (as well as other health care costs) at 6 month follow-up.
- In addition, the experimental group will report higher treatment satisfaction than the control group.
The following variables will be assessed:
- Clinical symptoms (anxiety, depression, somatizations), levels of adjustment (work, family, social),
- Quality of life (physical health, psychological, social, environmental),
- Emotional symptoms and thoughts (worries, beliefs, coping strategies, negative thoughts, etc.),
- Treatment satisfaction
- Frequent use of services
- Psychoactive drug use.
Patient recruitment
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A computer-generated allocation sequence was used to randomly assign patients (1:1) to receive either TD-GCBT plus TAU or TAU alone. All patients were assigned a code for blinding purposes and then the patient characteristics were sent to one of the investigators to check that they met the inclusion criteria. Patients who met the inclusion criteria were then randomized as described above.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient seeking Primary Care treatment at any of the selected sites in Spain with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire) may voluntarily participate in the study regardless of his/her age and sex.
排除标准
- •Patients with severe mental disorders (e.g., bipolar disorder, personality disorder)
- •Patients with a history of frequent or recent suicide attempt(s)
- •Patients with a high level of disability (as measured by the Sheehan Disability Scale) who seek Primary Care treatment.
- •Patients with severe anxiety disorders (e.g., comorbid substance use disorders) and severe mood disorders (Patient Health Questionnaire; PHQ-9 total score >= 20).
- •Patients who do not meet diagnostic criteria for a probable emotional disorder or do not reach the established PHQ cut-off points.
研究组 & 干预措施
Treatment-As-Usual (TAU)
Primary Care Treatment As Usual
干预措施: Primary Care Treatment As Usual (Drug)
Cognitive Behavioral Treatment (CBT)
Cognitive Behavioral Treatment. Seven 90-minute sessions of group treatment along 24 weeks.
干预措施: Cognitive Behavioral Treatment (Behavioral)
结局指标
主要结局
Somatic symptoms after psychological treatment versus Primary Care usual treatment.
时间窗: Up to two years.
Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) somatic symptoms (total frequency scores in somatic symptoms as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.
Anxiety symptoms after psychological treatment versus Primary Care usual treatment.
时间窗: Up to two years
Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) clinical symptoms of anxiety (total frequency scores in anxiety as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.
Depressive symptoms after psychological treatment versus Primary Care usual treatment.
时间窗: Up to two years.
Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition (DSM-IV) clinical symptoms of depression (total frequency scores in depression as measured by the Patient Health Questionnaire) as reported by patients after receiving psychological treatment or usual treatment.
次要结局
- Cognitive factors after psychological treatment versus Primary Care usual treatment.(Up to two years)
- Level of impairment after psychological treatment versus Primary Care usual treatment.(Up to two years)
- Quality of life after psychological treatment versus Primary Care usual treatment.(Up to two years)
- Frequency of primary care visits after psychological treatment versus Primary Care usual treatment.(Up to 18 months)