Satisfaction With Life and Quality of Life in Adults With Depressive and Anxious Symptoms: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Satisfaction with Life
研究概览
简要总结
In Portugal, there is an increase in cases of depression (from 6.9% to 9.8%) and anxiety (from 3.5% to 6.5%), among those enrolled in health care centers. Although the prevalence of both disorders' peaks in older adulthood, depression and anxiety often have their onset in youth. The high prevalence of psychological morbidity has been a cause for concern, given the associations between depression and anxiety in youth and other chronic mental disorders, stress, physical health problems and poorer quality of life (QoL), and physical disorders in older age.
The prevention of psychological morbidity in young people is crucial to reduce its adverse effects on young adults' development, school performance, social functioning, and to prevent its harmful impact on QoL. Cognitive behavioral therapy is considered the most effective intervention for the treatment of anxiety and depression in young people. In this study, a behavioral relaxation technique, i.e., relaxation, will be used. This technique has positive effects on psychological morbidity, specially Schultz's autogenic relaxation training.
Electrostimulation therapy, a non-invasive technique that uses electrical micro current for therapeutic purposes, is an innovative way of treating psychological morbidity, and has proven to be effective in reducing stress, depression and anxiety. Recently, studies found that cortical stimulation was associated with a reduction in depression, effects maintained after the treatment end. Also, there is evidence that there are improvements in depression, anxiety, pain and sleep, which were maintained after 4 treatment sessions.
Considering the high incidence of psychological morbidity in emerging adulthood, as well as its harmful impact on adulthood, the importance of this research aimed at reducing psychological morbidity in young adults and promoting QoL throughout life stands out. This study aims to answer the question "Does an electrostimulation therapy intervention have an impact on psychological morbidity and QoL when compared to a cognitive behavioral intervention?", with the main objective of contributing to reducing psychological morbidity in young adults, as well as promoting their QoL.
详细描述
The general aim of this pilot study is to assess the feasibility and acceptability of an intervention of electrostimulation versus relaxation with guided imagery (Cognitive Behavioral Therapy-TCC), according to four conditions: 1) Electrostimulation - Experimental Group 1 (EG1); 2) Relaxation with guided imagery + Electrostimulation - Experimental Group 2 (EG2); 3) Relaxation with guided imagery (standard) - Active Control Group (ACG); 4) Placebo (patients will be connected to the electrodes but receive no electrical stimulation) - Passive Control Group (PCG).
More specifically Pilot RCT specific aims:
- Compare ACG and PCG versus EG1 and EG2, over time, on physical and psychological morbidity, emotional reactivity, perceived stress, emotional regulation, satisfaction with life and QoL.
- To analyse the differences over time in the two experimental groups (EG1 and EG2) in physical and psychological morbidity, emotional reactivity, perceived stress, emotional regulation, life satisfaction and QoL.
- To explore, in EG1 and EG2, the mediating role of psychological morbidity in the relationship between emotional reactivity and life satisfaction/QoL over time.
- To explore the mediating role, in EG1 and EG2, of emotional regulation in the relationship between perceived stress, life satisfaction and QoL over time.
The study design is longitudinal with 3 evaluation moments: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2). At the end of the study, the PCG will be offered the opportunity to receive intervention whether electrical stimulation or relaxation with guided imagery.
b) Procedure The study plan is experimental (RCT) with randomization across four conditions: 1) Electrostimulation therapy - Experimental Group 1 (GE1); 2) Relaxation + Electrostimulation therapy - Experimental Group 2 (GE2); 3) Relaxation (standard) - Active Control Group (ACG); 4) Placebo (participants connected to the electrodes, but without emission of electrical frequency) - Passive Control Group (PCG).
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 (Participant, Investigator)
盲法说明
Participants will be randomized at a ratio of 1:1 for the four groups conditions. Randomization will be performed through an online random number generator by a researcher external to the team of this study, to ensure the concealment of the allocation of participants by the several groups. Only the participants will be blind to the group to which they have been allocated.
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
- •Participants need to present clinical levels of psychological morbidity (scores > 11 on the HADS
排除标准
- •Personality disorder, psychosis or bipolar disorder
- •Depression with psychotic features
- •Suicidal ideation
- •Use of defibrillator or pacemaker
- •Pregnancy
研究组 & 干预措施
Electrostimulation Therapy
Participants will undergo six electrostimulation sessions, which will take place once a week and will last 20 minutes. Participants complete a set of questionnaires at the following times: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2). The first session will include a psychoeducational component, where it will be explained that psychological morbidity and stress influence the immune system, with repercussions on QoL.
干预措施: Electrostimulation Therapy (Behavioral)
Relaxation + Electrostimulation Therapy
Participants have sessions of relaxation and electrostimulation therapy during 20 minutes. They will receive two sessions in the same week, one of electrostimulation therapy and another of relaxation. Also, participants complete a set of questionnaires at the following times: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2).
干预措施: Electrostimulation Therapy (Behavioral)
Relaxation + Electrostimulation Therapy
Participants have sessions of relaxation and electrostimulation therapy during 20 minutes. They will receive two sessions in the same week, one of electrostimulation therapy and another of relaxation. Also, participants complete a set of questionnaires at the following times: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2).
干预措施: Relaxation (Behavioral)
Relaxation (standard)
Participants will receive relaxations sessions weekly, and complete a set of questionnaires at the following times: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2).
干预措施: Relaxation (Behavioral)
Placebo
Participants will be connected to the handles but will not receive any frequency during the 20 minutes. The sessions will take place at the same location and with the same weekly frequency as EG1 and EG2. Also, they will complete a set of questionnaires at the following times: pre-test (T0), post-test (T1), and 1-month post-intervention follow-up (T2).
干预措施: Placebo (Behavioral)
结局指标
主要结局
Satisfaction with Life
时间窗: 1-month post-intervention follow-up
Satisfaction with Life it will be evaluated through Satisfaction with Life Scale with five items on a five-point Likert-Type scale, ranging from 1 "strongly disagree" to 5 "strongly agree". Scores range from 5 to 25, and higher scores suggest a greater level of satisfaction with life.
Mental and Physical Quality of Life
时间窗: 1-month post-intervention follow-up
This primary outcome it will be assessed with 12-Item Short Form Survey (SF-12). This instrument has 12 items with scores ranging from 0 to 100. Higher scores suggest a greater level of quality of life.
Satisfaction with Life
时间窗: Pre-test
Satisfaction with Life it will be evaluated through Satisfaction with Life Scale with five items on a five-point Likert-Type scale, ranging from 1 "strongly disagree" to 5 "strongly agree". Scores range from 5 to 25, and higher scores suggest a greater level of satisfaction with life.
Satisfaction with Life
时间窗: up to six weeks (post-test)
Satisfaction with Life it will be evaluated through Satisfaction with Life Scale with five items on a five-point Likert-Type scale, ranging from 1 "strongly disagree" to 5 "strongly agree". Scores range from 5 to 25, and higher scores suggest a greater level of satisfaction with life.
Mental and Physical Quality of Life
时间窗: Pre-test
This primary outcome it will be assessed with 12-Item Short Form Survey (SF-12). This instrument has 12 items with scores ranging from 0 to 100. Higher scores suggest a greater level of quality of life.
Mental and Physical Quality of Life
时间窗: up to six weeks (post-test)
This primary outcome it will be assessed with 12-Item Short Form Survey (SF-12). This instrument has 12 items with scores ranging from 0 to 100. Higher scores suggest a greater level of quality of life.
次要结局
- Physical Morbidity(Pre-test)
- Perceived stress(1-month post-intervention follow-up)
- Psychological Morbidity(1-month post-intervention follow-up)
- Emotional Regulation(1-month post-intervention follow-up)
- Emotional Reactivity(1-month post-intervention follow-up)
- Psychological Morbidity(up to six weeks (post-test))
- Perceived stress(Pre-test)
- Perceived stress(up to six weeks (post-test))
- Emotional Regulation(Pre-test)
- Emotional Regulation(up to six weeks (post-test))
- Emotional Reactivity(Pre-test)
- Emotional Reactivity(up to six weeks (post-test))
研究者
Maria da Graça Pereira
Associate Professor with tenure
University of Minho