Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students

NCT05114824 | Unknown

• 1 other identifier: FDI UAN1901-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Mental health problems -particularly depression- are the main cause of morbidity in young people (1), which has a known association with different health and social problems, such as increased alcohol consumption and drug dependence, adolescent pregnancy, school dropouts , criminal behavior, self-harm, and even suicide (2-4). MBCT is an intervention that has been shown to reduce depression, stress and anxiety in the adult and university population; however, its duration and time demands make it difficult to implement. The available evidence of mindfulness interventions in university students is heterogeneous, with various methodological flaws, and is based on self-applied programs such as Mindful Mood Balance (MMB), without the participation of instructors. The current study aim to explore the acceptability and feasibility of an intervention based on a Mindfulness-based Cognitive Therapy (MBCT) program with training in mindfulness strategies for 8 weeks. The adapted MBCT intervention will consist of eight weekly group sessions of 1 hour and 30 minutes, led by a certified instructor, to address the depressive and anxiety symptoms in the university population. In addition, the intervention will be complemented with the inclusion of audiovisual material, aimed at guiding self-applied daily exercises.

Conditions

Stress, Psychological; Anxiety Disorders; Depression, Unipolar

Keywords

Mindfulness; Students; MBCT; Mindfulness-Based Cognitive Therapy

Outcome Measures

Primary Outcomes (2)

• Acceptability and satisfaction

  To determine the acceptability and satisfaction of the participants with the intervention using the Client Satisfaction Questionnaire (CSQ-8) of the intervention. The CSQ-8 is an instrument validated in English, and translated and validated into Spanish of 8 items that measures general satisfaction with health services received in different populations. The responses are of the Likert type with 4 options each. The questions are: How would you rate the services received? Did you receive the kind of service you required? To what extent has our program helped solve your problems? If a friend were in need of similar help, would you recommend our program? How satisfied are you with the amount of help you have received? Have the services you received helped you better deal with your problems? Overall, how satisfied are you with the services you have received? If you needed help again, would you return to our program? In addition, it has space to write down comments and suggestions.

  1 week

• Feasibility assessment

  To determine the feasibility of study subject recruitment, participant retention, session attendance, and quantitative and qualitative data collection during an 8-week MBCT online program

  12 weeks

Secondary Outcomes (6)

• Patient Health Questionnaire (PHQ-9)

  12 weeks

• Generalized Anxiety Disorder 7 (GAD-7)

  12 weeks

• The alcohol, smoking and substance involvement screening test (ASSIST)

  12 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2

  12 weeks

• Five Facet Mindfulness Questionnaire (FFMQ)

  12 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Behavioral: Mindfulness-Based Cognitive Therapy

Control Group

NO INTERVENTION

Control group

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

The intervention is based on a mixed MBCT program with training in mindfulness strategies for 8 weeks. The adapted MBCT intervention will consist of eight weekly group sessions of 1 hour and 30 minutes, led by a certified instructor, to address the symptoms in the university population. In addition, complemented with the inclusion of audiovisual material, aimed at guiding self-applied daily exercises.

Also known as: MBCT

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

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

You may qualify if:

• Undergraduate students from the Universidad de los Andes, studying from 2nd to last year of undergraduate studies.
• Over 18 years.
• Able to read and speak Spanish.
• Scored on the PHQ-9 depression scale ≤ 14.
• Have participated in an informative meeting about the study and the implications of the intervention.
• Availability of time to participate in 1 weekly session of 90 minutes, for 8 consecutive weeks, and time to perform mindfulness exercises at home for at least 15 minutes a day, during the duration of the intervention.

You may not qualify if:

• With a PHQ-9 score greater than or equal to 15
• With active suicidality, defined as suicidal ideation, planning or attempt, or self-injurious behavior in the last 12 months.
• History of psychiatric treatment for a serious condition, understood as: psychotic pathology and / or substance abuse.
• History of hospital admission for psychiatric pathology, in the last 2 years.
• History of having participated in a previous Mindfulness-based course, such as: MBCT, MBSR, MMB, among others.
• History of severe trauma or sexual abuse.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Ministerio de Educación, Chile: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (10)

• Gili M, Castellvi P, Vives M, de la Torre-Luque A, Almenara J, Blasco MJ, Cebria AI, Gabilondo A, Perez-Ara MA, A MM, Lagares C, Pares-Badell O, Piqueras JA, Rodriguez-Jimenez T, Rodriguez-Marin J, Soto-Sanz V, Alonso J, Roca M. Mental disorders as risk factors for suicidal behavior in young people: A meta-analysis and systematic review of longitudinal studies. J Affect Disord. 2019 Feb 15;245:152-162. doi: 10.1016/j.jad.2018.10.115. Epub 2018 Oct 26.

  PMID: 30390504 BACKGROUND

• Slavin SJ, Schindler DL, Chibnall JT. Medical student mental health 3.0: improving student wellness through curricular changes. Acad Med. 2014 Apr;89(4):573-7. doi: 10.1097/ACM.0000000000000166.

  PMID: 24556765 BACKGROUND

• Hope V, Henderson M. Medical student depression, anxiety and distress outside North America: a systematic review. Med Educ. 2014 Oct;48(10):963-79. doi: 10.1111/medu.12512.

  PMID: 25200017 BACKGROUND

• Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.

  PMID: 29080597 BACKGROUND

• Demarzo M, Montero-Marin J, Puebla-Guedea M, Navarro-Gil M, Herrera-Mercadal P, Moreno-Gonzalez S, Calvo-Carrion S, Bafaluy-Franch L, Garcia-Campayo J. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study. Front Psychol. 2017 Aug 8;8:1343. doi: 10.3389/fpsyg.2017.01343. eCollection 2017.

  PMID: 28848465 BACKGROUND

• Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31.

  PMID: 25689576 BACKGROUND

• Blanck P, Perleth S, Heidenreich T, Kroger P, Ditzen B, Bents H, Mander J. Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis. Behav Res Ther. 2018 Mar;102:25-35. doi: 10.1016/j.brat.2017.12.002. Epub 2017 Dec 20.

  PMID: 29291584 BACKGROUND

• Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.

  PMID: 29422189 BACKGROUND

• Cebolla A, Demarzo M, Martins P, Soler J, Garcia-Campayo J. Unwanted effects: Is there a negative side of meditation? A multicentre survey. PLoS One. 2017 Sep 5;12(9):e0183137. doi: 10.1371/journal.pone.0183137. eCollection 2017.

  PMID: 28873417 BACKGROUND

• Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018 Sep 25;8(9):e022233. doi: 10.1136/bmjopen-2018-022233.

  PMID: 30257847 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depressive Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jorge Gaete Olivares, MD, PhD

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: September 23, 2021
• Primary Completion: December 30, 2021
• Study Completion: March 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)