Clinical trial NCT05099744: Interventions in Adults With Depressive and Anxious Symptoms
Official title: Satisfaction With Life and Quality of Life in Adults With Depressive and Anxious Symptoms: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Keywords: Electrical Stimulation
Relaxation
Satisfaction with Life
Quality of Life
Psychological Morbidity
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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.
2. 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.
3. To explore, in EG1 and EG2, the mediating role of psychological morbidity in the relationship between emotional reactivity and life satisfaction/QoL over time.
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction with Life
timeFrame: Pre-test
measure: Satisfaction with Life
timeFrame: up to six weeks (post-test)
measure: Satisfaction with Life
timeFrame: 1-month post-intervention follow-up
measure: Mental and Physical Quality of Life
timeFrame: Pre-test
measure: Mental and Physical Quality of Life
timeFrame: up to six weeks (post-test)
measure: Mental and Physical Quality of Life
timeFrame: 1-month post-intervention follow-up
Secondary outcomes:
measure: Physical Morbidity
timeFrame: Pre-test
measure: Psychological Morbidity
timeFrame: up to six weeks (post-test)
measure: Psychological Morbidity
timeFrame: 1-month post-intervention follow-up
measure: Perceived stress
timeFrame: Pre-test
measure: Perceived stress
timeFrame: up to six weeks (post-test)
measure: Perceived stress
timeFrame: 1-month post-intervention follow-up
measure: Emotional Regulation
timeFrame: Pre-test
measure: Emotional Regulation
timeFrame: up to six weeks (post-test)
measure: Emotional Regulation
timeFrame: 1-month post-intervention follow-up
measure: Emotional Reactivity
timeFrame: Pre-test
measure: Emotional Reactivity
timeFrame: up to six weeks (post-test)
measure: Emotional Reactivity
timeFrame: 1-month post-intervention follow-up
Other outcomes:
measure: Sociodemographic data
timeFrame: Pre-test
measure: Clinical data
timeFrame: Pre-test
Locations:
city: Braga
country: Portugal
facility: School of Psychology, University of Minho
Study officials:
affiliation: University of Minho
name: M. Graça M. Graça Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
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