Interventions in Adults With Depressive and Anxious Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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). The young adults (students) of the different courses of the University will be contacted online for participation in the study. Participation is voluntary. Experimental Group (EG1 and EG2) Electrostimulation therapy will include six 20-minute sessions, weekly. The EG2 will receive two sessions in the same week, one of electrostimulation therapy and another of relaxation (CT). The first session of EG1 and EG2 will include a psychoeducational component, where it will be explained that psychological morbidity and stress influence the immune system, with repercussions on QoL, and the objective of the intervention is to reduce depressive and anxious symptoms and the impact of stress. The relaxation sessions (CT) are based on Schultz's autogenic relaxation training, a relaxation technique based on autosuggestion. Passive Control Group Participants in the PCG will undergo a placebo in which they will be connected to the handles but will not receive any frequency during the 20 minutes. These sessions will take place at the same location and with the same weekly frequency as EG1 and EG2. Active Control Group (ACG) Participants in thr ACG will undergo relaxation (CT). The sessions, as the PCG, EG1 and EG2, will have weekly frequency. c) Sample size calculation The sample size calculation for a pilot RCT, considering the average effect size of 0.5, a statistical power of 80% and a significance level of 5%, revealed that 12 participants were needed in each of the groups. This approach considers that one-sided 80% confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true. d) Data analysis To assess the feasibility of this pilot study (aim 1), the rates of eligibility, recruitment and adherence to the study protocol, participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage. To obtain preliminary estimates of the intervention effects' on health outcome measures (aim 2), descriptive measures of the respective variables (means and standard deviations) will be calculated and Generalized Mixed Models will be used to check for statistically significant differences over time, in the different groups. Data will be analyzed using Statistical Package for the Social Sciences (IBM SPSS) version 27. e) Ethical considerations Young adults will be informed about the objectives of the study. If they accept to participate, they will be asked to complete the informed consent form. At the end of the suty, participants in the passive and active control groups will be given the opportunity to receive the relaxation intervention with guided imagination and electrostimulation therapy, respectively. The participants who, in the follow-up assessment, presented anxiety/depression symptoms above 8 will be informed of the possibility of enrolling in the Psychology Association to receive psychological support if they wish.

Official Title
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Satisfaction With Life and Quality of Life in Adults With Depressive and Anxious Symptoms: A Pilot Randomized Clinical Trial

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Electrostimulation Therapy
* Behavioral: Relaxation
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants need to present clinical levels of psychological morbidity (scores > 11 on the HADS Exclusion Criteria: Personality disorder, psychosis or bipolar disorder Depression with psychotic features Suicidal ideation Epilepsy Use of defibrillator or pacemaker Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrostimulation Therapy<br>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. | Behavioral: Electrostimulation Therapy<br>* During 20 minutes participants are connected to the handles and receive electrostimulation therapy.<br>|
| Experimental: Relaxation + Electrostimulation Therapy<br>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). | Behavioral: Electrostimulation Therapy<br>* During 20 minutes participants are connected to the handles and receive electrostimulation therapy.<br>Behavioral: Relaxation<br>* During 20 minutes participants receive a session of relaxation with guided imagination. These sessions will be implemented by a trained therapist who will follow a script. The relaxation sessions are based on Schultz's autogenic relaxation training, a relaxation technique based on autosuggestion.<br>|
| Active Comparator: Relaxation (standard)<br>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). | Behavioral: Relaxation<br>* During 20 minutes participants receive a session of relaxation with guided imagination. These sessions will be implemented by a trained therapist who will follow a script. The relaxation sessions are based on Schultz's autogenic relaxation training, a relaxation technique based on autosuggestion.<br>|
| Placebo Comparator: Placebo<br>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). | Behavioral: Placebo<br>* During 20 minutes participants will be connected to the handles but will not receive any frequency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Life | 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. | Pre-test | 
| Satisfaction with Life | 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. | up to six weeks (post-test) | 
| Satisfaction with Life | 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. | 1-month post-intervention follow-up | 
| Mental and Physical Quality of Life | 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. | Pre-test | 
| Mental and Physical Quality of Life | 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. | up to six weeks (post-test) | 
| Mental and Physical Quality of Life | 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. | 1-month post-intervention follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Morbidity | This outcome it will be evaluated by the Physical Symptoms Questionnaire (PHQ-15). This instrument consists of 15 items scored on a three-point Likert-type scale ranging from 0 not bothered at all to 2 bothered a lot. Scores range from 0 to 30, and higher scores indicate a greater severity of somatic symptoms. | Pre-test | 
| Psychological Morbidity | Psychological Morbidity it will be evaluated by the Hospital Anxiety and Depression Scale (HADS). This instrument has two subscales (i.e., anxiety and depression) and has 14 items scored on a four-point Likert-type scale ranging from 0 never to 3 always. Scores range from 0 to 42, and higher scores indicate higher levels of anxiety and depression. | up to six weeks (post-test) | 
| Psychological Morbidity | Psychological Morbidity it will be evaluated by the Hospital Anxiety and Depression Scale (HADS). This instrument has two subscales (i.e., anxiety and depression) and has 14 items scored on a four-point Likert-type scale ranging from 0 never to 3 always. Scores range from 0 to 42, and higher scores indicate higher levels of anxiety and depression. | 1-month post-intervention follow-up | 
| Perceived stress | This outcome it will be measured with Perceived Stress Scale (PSS). It contains 10 items rated on a five-point Likert-type scale, ranging from 0 never to 4 very often. Scores range from 0 to 40, and higher scores suggest higher levels of perceived stress. | Pre-test | 
| Perceived stress | This outcome it will be measured with Perceived Stress Scale (PSS). It contains 10 items rated on a five-point Likert-type scale, ranging from 0 never to 4 very often. Scores range from 0 to 40, and higher scores suggest higher levels of perceived stress. | up to six weeks (post-test) | 
| Perceived stress | This outcome it will be measured with Perceived Stress Scale (PSS). It contains 10 items rated on a five-point Likert-type scale, ranging from 0 never to 4 very often. Scores range from 0 to 40, and higher scores suggest higher levels of perceived stress. | 1-month post-intervention follow-up | 
| Emotional Regulation | Emotional Regulation will be assessed by Difficulties in Emotion Regulation Scale (DERS). It contains 36 items on a five-point Likert-type scale ranging from 1 rarely applies to me to 5 almost always applies to me. Scores range from 36 to 180, and higher scores reflect greater impairment or dysregulation. | Pre-test | 
| Emotional Regulation | Emotional Regulation will be assessed by Difficulties in Emotion Regulation Scale (DERS). It contains 36 items on a five-point Likert-type scale ranging from 1 rarely applies to me to 5 almost always applies to me. Scores range from 36 to 180, and higher scores reflect greater impairment or dysregulation. | up to six weeks (post-test) | 
| Emotional Regulation | Emotional Regulation will be assessed by Difficulties in Emotion Regulation Scale (DERS). It contains 36 items on a five-point Likert-type scale ranging from 1 rarely applies to me to 5 almost always applies to me. Scores range from 36 to 180, and higher scores reflect greater impairment or dysregulation. | 1-month post-intervention follow-up | 
| Emotional Reactivity | This outcome it will be measured by Affective States Inventory-Reduced (ASI-R). This instrument is composed of a list of words that designate emotions and measure emotional states. It contains 19 items on a five-point Likert-type scale ranging from 1 very little or not at all to 5 extremely. The scale contains five scales, such as negative (3 items), euphoric arousal (4 items), self-efficacy-related (4 items), Warmth (5 items) and Serenity emotions (3 items). Scores range from 3 to 15 in negative and serenity emotions subscales, from 4 to 20 in euphoric arousal and self-efficacy-related subscales, and from 5 to 25 in Warmth subscale. Higher scores indicate a higher degree to which individuals feel in the state described. | Pre-test | 
| Emotional Reactivity | This outcome it will be measured by Affective States Inventory-Reduced (ASI-R). This instrument is composed of a list of words that designate emotions and measure emotional states. It contains 19 items on a five-point Likert-type scale ranging from 1 very little or not at all to 5 extremely. The scale contains five scales, such as negative (3 items), euphoric arousal (4 items), self-efficacy-related (4 items), Warmth (5 items) and Serenity emotions (3 items). Scores range from 3 to 15 in negative and serenity emotions subscales, from 4 to 20 in euphoric arousal and self-efficacy-related subscales, and from 5 to 25 in Warmth subscale. Higher scores indicate a higher degree to which individuals feel in the state described. | up to six weeks (post-test) | 
| Emotional Reactivity | This outcome it will be measured by Affective States Inventory-Reduced (ASI-R). This instrument is composed of a list of words that designate emotions and measure emotional states. It contains 19 items on a five-point Likert-type scale ranging from 1 very little or not at all to 5 extremely. The scale contains five scales, such as negative (3 items), euphoric arousal (4 items), self-efficacy-related (4 items), Warmth (5 items) and Serenity emotions (3 items). Scores range from 3 to 15 in negative and serenity emotions subscales, from 4 to 20 in euphoric arousal and self-efficacy-related subscales, and from 5 to 25 in Warmth subscale. Higher scores indicate a higher degree to which individuals feel in the state described. | 1-month post-intervention follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Stimulation, Relaxation, Satisfaction with Life, Quality of Life, Psychological Morbidity