Interventions in Adults With Depressive and Anxious Symptoms

NCT05099744 | Recruiting DMC

• 1 other identifier: EST20212022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

Electrical Stimulation; Relaxation; Satisfaction with Life; Quality of Life; Psychological Morbidity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Physical Morbidity

  Pre-test

• Psychological Morbidity

  up to six weeks (post-test)

• Psychological Morbidity

  1-month post-intervention follow-up

• Perceived stress

  Pre-test

• Perceived stress

  up to six weeks (post-test)

Other Outcomes (2)

• Sociodemographic data

  Pre-test

• Clinical data

  Pre-test

Study Arms (4)

Electrostimulation Therapy

EXPERIMENTAL

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

Relaxation + Electrostimulation Therapy

EXPERIMENTAL

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; Behavioral: Relaxation

Relaxation (standard)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Electrostimulation Therapy BEHAVIORAL

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

Electrostimulation Therapy; Relaxation + Electrostimulation Therapy

Relaxation BEHAVIORAL

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.

Relaxation (standard); Relaxation + Electrostimulation Therapy

Placebo BEHAVIORAL

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minho: lead

Study Sites (1)

School of Psychology, University of Minho

Braga, 4710-057, Portugal

RECRUITING

Related Publications (26)

• 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.

  PMID: 22196195 BACKGROUND

• 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.

  PMID: 16367493 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11914441 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 17365902 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17434406 BACKGROUND

• Hickey L, Hannigan A, O'Regan A, Khalil S, Meagher D, Cullen W. Psychological morbidity among young adults attending primary care: a retrospective study. Early Interv Psychiatry. 2018 Feb;12(1):22-29. doi: 10.1111/eip.12284. Epub 2015 Oct 15.

  PMID: 26472345 BACKGROUND

• Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.

  PMID: 24433257 BACKGROUND

• Creswell C, Waite P, Cooper PJ. Assessment and management of anxiety disorders in children and adolescents. Arch Dis Child. 2014 Jul;99(7):674-8. doi: 10.1136/archdischild-2013-303768. Epub 2014 Mar 17.

  PMID: 24636957 BACKGROUND

• Klainin-Yobas P, Oo WN, Suzanne Yew PY, Lau Y. Effects of relaxation interventions on depression and anxiety among older adults: a systematic review. Aging Ment Health. 2015;19(12):1043-55. doi: 10.1080/13607863.2014.997191. Epub 2015 Jan 9.

  PMID: 25574576 BACKGROUND

• Schultz JH. Autogenic Therapy: Luthe, W. Treatment with autogenic neutralization. New York: Grune & Stratton; 1969.

  BACKGROUND

• Mellen RR, Mackey W. Cranial electrotherapy stimulation (CES) and the reduction of stress symptoms in a sheriff's jail security and patrol officer population: A pilot study. American Jails. 2008;22(5):32-8.

  BACKGROUND

• McClure D, Greenman SC, Koppolu SS, Varvara M, Yaseen ZS, Galynker II. A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression. J Nerv Ment Dis. 2015 Nov;203(11):827-35. doi: 10.1097/NMD.0000000000000378.

  PMID: 26414234 BACKGROUND

• Bystritsky A, Kerwin L, Feusner J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. J Clin Psychiatry. 2008 Mar;69(3):412-7. doi: 10.4088/jcp.v69n0311.

  PMID: 18348596 BACKGROUND

• Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.

  PMID: 17559710 BACKGROUND

• Yennurajalingam S, Kang DH, Hwu WJ, Padhye NS, Masino C, Dibaj SS, Liu DD, Williams JL, Lu Z, Bruera E. Cranial Electrotherapy Stimulation for the Management of Depression, Anxiety, Sleep Disturbance, and Pain in Patients With Advanced Cancer: A Preliminary Study. J Pain Symptom Manage. 2018 Feb;55(2):198-206. doi: 10.1016/j.jpainsymman.2017.08.027. Epub 2017 Sep 21.

  PMID: 28870799 BACKGROUND

• Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.

  PMID: 17092344 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• M. Graça M. Graça Pereira, PhD

  University of Minho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Graça M. Graça Pereira, PhD

CONTACT

+351 253604683; gracep@psi.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor with tenure

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 29, 2021
• Study Start: December 2, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

PT (1)