The Impact of Spiritual Healing on Moderate Depression in Adults: A Pilot Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Feasibility of the study
研究概览
简要总结
Depression is a common mental disorder and is together with anxiety the global leading cause of all non-fatal burden of disease. Currently supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. This is particularly the case for patients suffering from moderate depression. Many patients who suffer from depression turn to complementary and alternative medicine (CAM), and among those therapies often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients suffer from depression, and that spiritual healing is associated with low risk. The objective of this study is therefor to conduct a pilot RCT (spiritual healing as addition to usual care versus usual care alone) in preparation of a larger trial in adults with moderate depression to examine feasibility and individuals' experience of spiritual healing.
This study is a pilot randomized controlled trial (RCT) with two parallel groups. A total of 28 adult patients with moderate depression according to the M.I.N.I. PLUS DSM-V criteria will be randomized to spiritual healing in addition to usual care intervention (n=14) or usual care alone (n=14). Ten treatment sessions (lasting 45-60 minutes each) of spiritual healing will be administered as an adjunct to usual care and compared to usual care alone. Reduction in depression symptoms will be measured with Beck Depression Inventory (BDI) and Montgomery and Åsberg Depression Rating Scale (MADRS) collected at baseline, week 8 and 16, in addition to BDI measurement collected 6 and 12 months after inclusion in the study. To investigate participants' experience with spiritual healing, a qualitative study will be included using a phenomenological hermeneutical method and semi-structured interviews.
详细描述
Background Depression is a common mental disorder and is together with anxiety the global leading cause of all non-fatal burden of disease. The core symptoms of depression are lowered mood, discouragement, loss of sense and meaning in life, lack of interest in other people and ordinary duties, and lack of energy and appetite. In addition, often diminished self-esteem, self-reproach and a feeling of guilt. These symptoms may vary in intensity and duration. Nevertheless, around half of people with depression worldwide do not receive treatment. Most mental disorders emerge before the age of 30, and lack of treatment might contribute to disability for many crucial years of an individual's life. In Norway, the 12 months prevalence and lifetime prevalence of depression is 10% and 20% respectably, higher in women than in men. Depression has been identified as a strong predictor for use of complementary and alternative medicine (CAM). A recent Norwegian study demonstrates that only 10.9% of those with moderate depression and/or anxiety visited psychiatric outpatient services while 17.6 % visited a complementary and alternative medicine (CAM) provider. This fact demonstrates that people with depression might be willing to seek help also from less established sources, such as CAM providers. Thus, it is possible that different CAM modalities may serve as a substitute or an alternative when access to psychologist/psychiatric services is limited.
Conventional medicine classifies depression as a mood disorder that manifests itself across a wide range of disease/symptom severity. Depression can be classified as mild, moderate or severe. Symptoms must have been persistent for at least two weeks and not be related to other medical or psychiatric diagnoses, or be due to substances. The World Health Organization ranks the social costs of depression as the 4th highest of all diseases. Furthermore, by 2020 current trends indicate that depression will represent the highest cost to society of any disease. Clearly, prevention, early diagnosis and intervention of depression have huge social significance.
The most commonly prescribed antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs) have recently been shown to have best effect on severe depression, and no effect beyond placebo for mild and moderate depression. At the same time, SSRIs can be associated with serious adverse effects, and are associated with a higher vulnerability to develop a depressive episode later in life. Thus, one of the most common treatment options for depression has been documented to be of little or no help beyond placebo for moderate depression while at the same time possibly inducing serious adverse effects.
The Norwegian minister of health, Bent Høye, has taken the patients' request for an improved treatment situation seriously, and sent a letter to the five regional health authorities in which he wrote: "Many patients in psychological health care do not want to be treated with medication. These patients must be heard and taken seriously. Patients cannot be forced to take medication as long as necessary care and treatment can be provided otherwise".
Cognitive behavioral therapy (CBT) or structured psychological therapy should always be offered patients who do not receive, or do not want pharmaceutical antidepressant treatment. However, the waiting list for such treatments is often long due to the lack of competent professionals (psychologists and psychiatrist), especially in rural communities, but also at the district psychiatric centers are there long waiting lists for such treatments. These centers have to prioritize patients with major depression, meaning that patients with moderate depression have even less access to CBT.
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
- Double (Investigator, 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
- 否
入选标准
- •Fulfill the criteria for moderate depression
- •Have symptoms for two weeks or more
- •A minimum of six of the following nine symptoms must have been present:
- •Depressed mood most of the day
- •Markedly diminished interest or pleasure in all activities
- •Significant weight loss or weight gain (more than 5%)
- •Insomnia or hypersomnia
- •Psychomotor agitation or retardation
- •Feelings of worthlessness
- •Excessive or inappropriate guilt
- •Diminished ability to concentrate
- •Minimum one of the six symptoms must be either depressed mood or loss of interest and pleasure.
排除标准
- •Symptoms as a direct physiological effects of a substance or a general medical condition
- •Substance abuse
- •Chronic major or bipolar depression or axis I diagnosis
- •Endocrine abnormality; medical disorder or treatment that could cause depression
- •Suicidal potential
- •Depression due to uncomplicated grief
- •History of psychosis or mania
- •Heart valve disease
- •Poorly controlled hypertension and diabetes mellitus
- •Pregnancy
- •Inability to complete study forms.
结局指标
主要结局
Feasibility of the study
时间窗: through study completion, an average of 2 year".
• Recruitment speed. * The recruitment speed will be recorded in a separate form including the following categories: * Dates for first contact with GP * Dates for signed consent form * Dates for baseline data collection * Data for first healing or usual care consultation. * Willingness to be randomized will be collected descriptively. The participants will be interviewed about their willingness to be randomized and asked about pros and cons of randomization and input on how to improve the randomization procedure. * Study adherence will be collected descriptively. The participants will be interviewed about any obstacles in the study flow and possible improvements. * Implementation of healing will be collected descriptively. The participants randomized to healing will be interviewed and asked about the implementation of the healing sessions. The investigators will asked about the participants experiences of the healing treatment (pros and cons).
次要结局
- Beck Depression Inventory (BDI) rating scale(Baseline, 8 and 16 weeks)
- Montgomery and Åsberg Depression Rating Scale (MADRS)(Baseline, 8 and 16 weeks, 6 and 12 months.)
- Semi-structured interviews(16 weeks after first participant enrollment until 16 weeks after the last participant has been enroled in the study.)
