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AnxietyNCT05099744

Interventions in Adults With Depressive and Anxious Symptoms

A study testing Electrostimulation Therapy and Relaxation in people with Anxiety and Depression, run by University of Minho at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression
What is being tested?
Electrostimulation Therapy and Relaxation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 sitePortugal
Study dates
2 Dec 2021to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants need to present clinical levels of psychological morbidity (scores > 11 on the HADS

Who cannot join

  • Personality disorder, psychosis or bipolar disorder
  • Depression with psychotic features
  • Suicidal ideation
  • Epilepsy
  • Use of defibrillator or pacemaker
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

M. Graça M. Graça Pereira, PhD contact

+351 253604683

gracep@psi.uminho.pt

Portugal1 site, 1 recruiting

  • School of Psychology, University of Minho

    Braga, 4710-057

    M. Graça M. Graça Pereira, PhD, +351 253604683, gracep@psi.uminho.pt

    Recruiting

Other trials in Portugal

About this study

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

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.

Read more

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.

Read the 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
Conditions
Anxiety, Depression
Being tested
Electrostimulation Therapy, Relaxation, Placebo
Keywords
Electrical Stimulation, Relaxation, Satisfaction with Life, Quality of Life, Psychological Morbidity
Medical subject headings
Anxiety Disorders, Depression, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrostimulation TherapyBehavioural

    During 20 minutes participants are connected to the handles and receive electrostimulation therapy.

  • RelaxationBehavioural

    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.

  • PlaceboBehavioural

    During 20 minutes participants will be connected to the handles but will not receive any frequency.

Study groups in NCT05099744
Study groupRoleWhat they receive
Electrostimulation TherapyExperimentalParticipants 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.
Receives: Behavioral: Electrostimulation Therapy
Relaxation + Electrostimulation TherapyExperimentalParticipants 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).
Receives: Behavioral: Electrostimulation Therapy; Behavioral: Relaxation
Relaxation (standard)Active comparatorParticipants 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).
Receives: Behavioral: Relaxation
PlaceboPlacebo comparatorParticipants 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).
Receives: Behavioral: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-test

  2. 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.

    Measured: up to six weeks (post-test)

  3. 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.

    Measured: 1-month post-intervention follow-up

  4. 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.

    Measured: Pre-test

  5. 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.

    Measured: up to six weeks (post-test)

  6. 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.

    Measured: 1-month post-intervention follow-up

Secondary outcomes (12)

  1. 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.

    Measured: Pre-test

  2. 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.

    Measured: up to six weeks (post-test)

  3. 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.

    Measured: 1-month post-intervention follow-up

  4. 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.

    Measured: Pre-test

  5. 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.

    Measured: up to six weeks (post-test)

  6. 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.

    Measured: 1-month post-intervention follow-up

  7. 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.

    Measured: Pre-test

  8. 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.

    Measured: up to six weeks (post-test)

  9. 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.

    Measured: 1-month post-intervention follow-up

  10. 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.

    Measured: Pre-test

  11. 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.

    Measured: up to six weeks (post-test)

  12. 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.

    Measured: 1-month post-intervention follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start2 Dec 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099744
Sponsor's protocol ID
EST20212022
Status last verified
May 2024
First submitted
23 Sep 2021
Last updated
9 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pandis N. Randomization. Part 3: allocation concealment and randomization implementation. Am J Orthod Dentofacial Orthop. 2012 Jan;141(1):126-8. doi: 10.1016/j.ajodo.2011.09.003. No abstract available.

    PubMed 22196195

  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PubMed 16367493

  • Simões A. Ulterior validação de uma escala de satisfação com a vida (SWLS). Revista Portuguesa de pedagogia. 1992;26(3):503-15.

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • Ferreira PL. A medição do estado de saúde: criação da versão portuguesa do MOS SF-36 [Internet]. Universidade de Coimbra, Centro de Estudos e Investigação em Saúde; 1998 [cited 2021 Sep 3]. Available from: https://estudogeral.sib.uc.pt/handle/10316/9969

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

    PubMed 11914441

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.

    PubMed 17365902

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Trigo M, Canudo N, Branco F, Silva D. Estudo das propriedades psicométricas da Perceived Stress Scale (PSS) na população portuguesa. Psychologica. 2010 Dec 1;(53):353-78. doi: 10.14195/1647-8606_53_17

  • Gratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment. 2004 Mar 1;26(1):41-54. doi: 10.1023/B:JOBA.0000007455.08539.94

  • Coutinho J, Ribeiro E, Ferreirinha R, Dias P. Versão portuguesa da escala de dificuldades de regulação emocional e sua relação com sintomas psicopatológicos. Rev psiquiatr clín. 2010;37(4):145-51. doi: 10.1590/S0101-60832010000400001

  • Moreira JM. Inventário de Estados Afetivos-Reduzido: Uma Medida Multidimensional Breve de Indicadores Emocionais de Ajustamento. 2016;14. https://www.redalyc.org/articulo.oa?id=459646901012

  • Retrato da Saúde 2018 [Internet]. [cited 2021 Sep 21]. Available from: https://www.sns.gov.pt/retrato-da-saude-2018/

  • Patel V, Flisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health challenge. Lancet. 2007 Apr 14;369(9569):1302-1313. doi: 10.1016/S0140-6736(07)60368-7.

    PubMed 17434406

Questions about this trial

What is this clinical trial studying?

A study testing Electrostimulation Therapy and Relaxation in people with Anxiety and Depression, run by University of Minho at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact M. Graça M. Graça Pereira, PhD (+351 253604683, gracep@psi.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with Life (time frame: Pre-test). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099744, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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