OPTIMA: Psychological Distress and the Effect of Intensive Group Based Cognitive Therapy in Patients With Newly Diagnosed Ischemic Heart Disease: A Randomised Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- The primary outcome of the RCT is anxiety and depression measured by HADS
研究概览
简要总结
The overall objectives of the Optima project is to: (1) Compare the effect of standardized group based cognitive therapy and cardiac rehabilitation versus usual cardiac rehabilitation in patients with sign of psychological distress measured by a questionnaire (HADS score), (2) To investigate spontaneous variation in psychological distress with HADS over time in order to optimize time of measuring HADS. (3) To investigate if the intervention can be implemented to other cardiac rehabilitation sites with the same effect as on BFH (that it is not person dependent).
详细描述
HYPOTHESIS: There will be a significant difference in anxiety and depression score between intervention and usual care groups after intervention, in favor of the intervention group.
METHODS: Optima is a multi-center, prospective, randomized clinical trial in patients with newly diagnosed ischemic heart disease (IHD) or heart valve replacement, and concomitant significant score of psychological distress using the Hospital Anxiety and Depression Score (HADS) (HADS A(Anxiety) /D(Depression) ≥8 or HADS>15), age <65 years. Patients with HADS D≥11 and Beck Depression Inventory (BDI)>17 are evaluated by psychiatrists to offer the best treatment. 148 patients will be randomized to either intervention or control group. All patients are offered usual cardiac rehabilitation, and in addition, the intervention group is offered standardized group based cognitive therapy with the participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse. The intervention was developed on experiences from a Liaison nurse, who offered up to five individual consultations to patients with psychological distress. Together with a psychologist specialized in cognitive therapy the investigators developed a program based on cognitive behavioral methods from cognitive therapy as well as Acceptance and commitment therapy (ACT). Each session consists of specific cognitive models, which the patient can use in everyday life.
INTERVENTION: Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.
The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.
When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising.
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
- 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
- •HADS score > 8 for HADS-A or HADS-D
- •Age < 65 years
- •Able to speak and understand Danish
排除标准
- •Participation in rehabilitation program within the last 2 years
- •Ejection Fraction (EF) < 35%
- •Other serious comorbidity that are expected to have a serious impact on life expectancy
- •Known abuse of alcohol or euphoric drugs. Known more serious psychopathology such as schizophrenia, bipolar disorder, severe personality disorder, and treatment with psychoactive drugs
研究组 & 干预措施
Cardiac rehabilitation+cognitive therapy
The intervention group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively.
In addition, the intervention group follows a standardized group based cognitive therapy program with participation of maximum four patients, consisting of 5 sessions (each 2 hours) performed by a trained cardiac rehabilitation nurse.
干预措施: Group based cognitive therapy (Behavioral)
Cardiac rehabilitation
The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .
Control group without psychological distress
The control group receives usual cardiac rehabilitation, which consists of 8-wk supervised outpatient exercise with 2 weekly sessions of 1,5 hr with high-intensity interval and resistance training. The program was complemented with a weekly session of group-based patient education for 1,5 hr on heart disease, psychological issues and diet counseling. In addition, patients had one or more individual sessions with a cardiologist and a nurse respectively. .
结局指标
主要结局
The primary outcome of the RCT is anxiety and depression measured by HADS
时间窗: 6 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
The primary outcome of the RCT is anxiety and depression measured by HADS
时间窗: 3 months follow-up
The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that assesses anxiety and depression level in medically ill persons who are not admitted in psychiatric wards. The scale range is from 0 to 42, the lesser the score, the lesser signs of psychological distress.The scale offers two scores, HADS-A and HADS-D, and consists of seven questions to assess anxiety and seven questions to assess depression.
次要结局
- Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL(6 months follow-up)
- Adherence to cardiac rehabilitation, health-related quality of life measured by HeartQoL(3 months follow-up)
研究者
Hanne Kruuse Rasmusen
Associate Professor
University Hospital Bispebjerg and Frederiksberg