The Effectiveness of Psychological Interventions for Common Mental Disorders (EPIC): A Randomized Waitlist-controlled Superiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)
研究概览
简要总结
The primary aim of "the Effectiveness of Psychological Interventions for Common mental disorders" (EPIC) randomized controlled trial is to investigate whether a significantly larger symptom improvement is observed after approximately four months of psychotherapeutic treatment in the Danish primary sector compared to in a waiting list control group. The secondary aim of the study is to identify specific client and therapy characteristics that may predict the effectiveness of the therapy or the symptom development in the waiting list control group. The main hypothesis of the EPIC trial is:
1) Four and a half months after randomization, we will find a significantly lower level of symptoms on the primary outcome measure (PHQ-ADS) among clients who receive psychotherapy, compared to clients in the waiting list control group. In addition, we hypothesize to find significantly better outcomes in the psychotherapy group on all secondary outcome measures, four and a half months after randomization.
Researchers will compare:
- Psychotherapy starting within 14 days after the randomization date with
- Placement on a waiting list for psychotherapy with treatment starting approximately four and a half months after the randomization date
to investigate whether a larger symptom improvement is observed in the group receiving psychotherapy compared to the waiting list control group.
Participants will:
- Be referred by their general practitioner (GP) for publicly subsidized psychotherapy treatment in the primary care sector in Denmark, based on one of 11 referral reasons.
- Complete the baseline questionnaire containing background information, the primary and secondary outcome measures, and predictor questionnaires, and subsequently be randomized to either psychotherapy beginning within two weeks or a waiting list control group.
- Receive a brief symptom questionnaire (the PHQ-ADS) every other week after the randomization date via an SMS-based solution provided by REDCap.
- Complete the primary and secondary outcome measures approximately four and a half, eight and a half, and 16 and a half months after the randomization date.
详细描述
Aims:
The primary aim of this randomized controlled trial is to investigate whether a significantly higher symptom improvement is observed after approximately four months of psychotherapeutic treatment in the Danish primary sector compared to a waiting list control group. A supplementary aim is to explore whether the treatment effect is maintained during follow-up assessed approximately eight and 16 months after the beginning of treatment. The secondary aim of the study is to investigate whether specific client and therapy characteristics predicting the effect of the therapy and the symptom change in the waitlist control group can be identified, and whether the quality of the therapeutic alliance measured after approximately five weeks of therapy is related to the outcome of therapy.
The hypotheses of the study are as follows:
- Four and a half months after randomization, we will find a significantly lower level of symptoms on the primary outcome measure (PHQ-ADS) among clients who receive psychotherapy, compared to clients in the waiting list control group. In addition, we hypothesize to find significantly better outcomes in the psychotherapy group on all secondary outcome measures, four and a half months after randomization.
- We expect that the client's coping strategies, emotion regulation strategies, and level of personality pathology will be significantly related to symptom change and treatment dropout amongst the clients receiving psychotherapy, and to symptom change in the waitlist group, four and a half months after randomization.
- We expect that the quality of the working alliance after approximately five weeks of therapy will be significantly related to symptom change on the PHQ-ADS after four and a half months of therapy. Conversely, we do not expect that the therapeutic orientation of the psychologist will be independently related to symptom change after four and a half months of therapy.
- We will explore whether the symptom change observed after approximately four and a half months persists eight and a half and 16 and a half months after the beginning of therapy.
Primary Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All clients who meet the criteria for one of the eleven referral reasons for psychotherapeutic treatment in the Danish primary sector.
- •Clients who read and speak proficient Danish to fill in the questionnaires.
- •Clients who agree to be randomized through their informed consent.
- •Psychologists:
- •All practicing psychologists employed by the Danish primary sector.
- •Psychologists who can commit to the deadlines for beginning treatment.
- •Psychologists with at waiting time of approximately four months or longer.
排除标准
- •- Clients considered unfit for participation or urgently needing psychological or medical help, as determined by the therapist.
研究组 & 干预措施
Wailist Control Group
Description: Clients in the waitlist control group will be placed on a waiting list for psychotherapy with treatment starting approximately four and a half months after the date of randomization.
Objective: To serve as a control group to the intervention group receiving psychotherapy and to investigate distinct symptom trajectories during the waiting period.
干预措施: Waiting List for Psychotherapeutic Treatment (Other)
Psychotherapy Intervention Group
Description: Clients in the psychotherapy intervention group will receive psychotherapeutic treatment with treatment starting within 14 days of the randomization date.
Objective: To determine the effectiveness of psychotherapy in the Danish primary sector over approximately a four-month period.
干预措施: Psychotherapeutic treatment (Other)
结局指标
主要结局
Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)
时间窗: Measured at: Baseline, bi-weekly, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date
The PHQ-ADS combines the PHQ-9 and the GAD-7 in to a composite measure of depression and anxiety. The PHQ-ADS sums the PHQ-9 and the GAD-7 in to a total score ranging from 0 to 48. The PHQ-ADS has demonstrated high internal reliability as well as convergent validity and con-struct validity in a large sample of primary care patients.
次要结局
- The Negative Effects Questionnaire (NEQ)(Measured at: Baseline and four and a half months after randomization date.)
- The WHO-5 well-being index (WHO-5)(Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date)
- The Client Satisfaction Questionnaire (CSQ)(Measured at: Baseline, four and a half months after randomization date.)
- Sheehan Disability Scale (SDS)(Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date)
- Cohen's Perceived Stress Scale (PSS)(Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date)