Reward Under Stress: Effects of a Multidimensional Stress Prevention Program in University Students

NCT03861013 | Completed

• 2 other identifiers: Reward_StressProject 6239
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of a multidimensional stress prevention program on psychological and physiological indicators among university students.

Conditions

Stress, Psychological

Keywords

Stress management; Intervention program; University students; Perceived stress; Mental health; Anxiety; Depression; Quality of life; Sense of coherence; Self-efficacy; Social support; Resilience; Psychological resources; Reward; Cortisol; Ambulatory assessment

Outcome Measures

Primary Outcomes (24)

• Change in depression scores

  Score on the Beck Depression Inventory (BDI-II). The BDI-II is a 21-item self-report screening assessing current symptoms of depression. Total score are ranging from 0 to 63. Higher scores indicate severe depressive symptoms.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in anxiety trait and state scores

  Score on State-Trait Anxiety Inventory (STAI). The STAI is a 40-item inventory designed to assess anxiety levels. Two subscores can be calculated: state and trait anxiety, scores are ranging from 20-80 for each subscore. Higher scores indicate greater anxiety.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in sense of coherence scores

  Score on Sense of Coherence Scale (SOC-13). Sense of coherence is defined as: a global orientation that expresses the extent to which one has a pervasive, enduring though dynamic feeling of confidence that (1) the stimuli deriving from one's internal and external environments in the course of living are structured, predictable, and explicable (comprehensibility); (2) the resources are available to one to meet the demands posed by these stimuli (manageability) ; and (3) these demands are challenges, worthy of investment and engagement (meaningfulness) (Antonovsky, 1987, p.19). This13-item scale measures the sense of coherence, composed of three domains: comprehensibility (scores ranged between 5 and 35), manageability (scores ranged between 4 and 28) and meaningfulness (scores ranged between 4 and 28). A score for each domain and a total score can be obtained by adding the scores. A high total score (ranged between 13 and 91) expresses a stronger sense of coherence.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in burnout scores

  Maslach Burnout Inventory (MBI), student version. This a 27-item inventory that evaluates the frequency of burnout in students. Three subscales can be computed by adding the items: the Emotional Exhaustion (EE) (scores ranging from 0 to 54), the Depersonalization (DP) (scores between 0 and 42), and the Personal Accomplishment (PA) (scores between 0 and 66). Higher scores in EE and DP and low scores in PA expresses higher level of burnout. A total score can also be computed by averaging all items (scores: ranged between 0 and 81). A high total score expresses high level of burnout.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in social anxiety scores

  Score on Liebowitz Social Anxiety Scale (LSAS-SR). It is a 24-item measure assessing social anxiety symptoms severity. Two subscales can be calculated: fear and avoidance of different social situations. A total score can also be calculated by adding the scores obtained in each subscale. Total scores are ranging from 0-144. Higher scores indicated higher levels of social anxiety.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in quality of life scores

  Score on the World Organization Quality of Life (WHOQOL-BREF). This 26-item version of the WHOQOL assess shortly the quality of life. A global score and four domains: physical (PHYS), psychological (PSYCH), social (SOC) and environmental (ENVIR) quality of life can be computed. The four domains are computed by averaging the items, this score can be multiplied by four to compare with the domains of the WHOQOL-100. The scores are ranged between 0 and 100. Higher scores mean higher perception of quality of life.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in difficulties in emotion regulation scores

  Score on Difficulties in Emotion Regulation Scale (DERS). This brief self-report 36 item questionnaire evaluates multiple aspects of emotion dysregulation. Six subscales can be computed: non acceptance of emotional responses (scores ranging from 1 to 30), difficulties engaging in goal directed behavior (scores ranging from 1 to 25), impulse control difficulties (scores ranging from 1 to 30), lack of emotional awareness (scores ranging from 1 to 30), limited access to emotion regulation strategies (scores ranging from 1 to 40), lack of emotional clarity (scores ranging from 1 to 25). A score total can be obtained by adding the scores of the 6 subscales (scores ranging from 6 to 180), with higher scores indicating higher difficulties in emotion regulation.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in perceived stress scores

  Score on Perceived Stress Scale (PSS). This 14-item scale measures degree to which situations in one's life are appraised as stressful. Higher scores indicate a higher level of perceived stress (scores ranging from 0 to 56).

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in general self-efficacy scores

  Score on the General Self-Efficacy Scale (GSE). This 10-items scale assess the general self-efficacy. A higher score (ranging from 10 to 40) indicates a better general self-efficacy.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in mindfulness skills scores

  Score on Kentucky Inventory of Mindfulness Skills (KIMS). This 39-item self-report questionnaire measures four dimensions : observing (scores ranging from 12 to 60), describing (scores ranging from 8 to 40), acting with awareness (scores ranging from 10 to 50)and accepting without judgment (scores ranging from 9 to 45).

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in symptoms of mental health scores

  Scores on Symptom Checklist (SCL-27-plus), a multidimensional screening instrument for mental problems. Composed of 27 items, 5 scales on current symptoms can be evaluated: depressive (scores ranging from 0 to 10), vegetative (scores ranging from 0 to 10), agoraphobic (scores ranging from 0 to 8), and sociophobic symptoms (scores ranging from 0 to 10) and pain (scores between 0 and 12). Each scale is computed by averaging the corresponding items. A global severity index can also be computed by averaging 25 items (score between 0 and 50). A lifetime assessment for depressive symptoms (sum of the items, scores ranged between 5 = possible lifetime depression and 10= no depression) and a screening question for suicidality (sum of 3 items, scores ranged between 3 = risk of suicide and 6 = little or no risk) are also included.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in self-compassion scores

  Score on Self-compassion Scale Short Form (SCS-SF). This 12-item scale evaluates a global score of self-compassion and 6 subscales: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness and Over-Identification. Higher scores indicating greater self-compassion. Each subscale can be computed by calculating the mean of subscale items (scores between 1 and 2, 5). The global score is obtained by computing the grand mean.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in perceived social support scores

  Score on Multidimensional Scale of Perceived Social Support (MSPSS). A 12-item questionnaire designed to evaluate perceived social support from three sources: Family, Friends and Significant others, by doing the mean of the subscale items. A total score can also be computed by averaging all items. Scores are ranged between 1 and 7. Higher scores indicating higher perceived social support.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in reward responsiveness scores

  Score on Reward Responsiveness and Behavioral Inhibition System Scale (RR/BIS). A 15-items self-reporting questionnaire designed to assess the sensitivity to punishment (BIS) and reward (RR). A score is calculated for each of the two scales (RR: scores ranging from 8 to 32; and BIS scores ranging from 7 to 28) by adding the scores of subscale' items. Higher scores indicated higher sensitivity to reward or punishment.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in self-esteem scores

  Score on Self-esteem Scale (RSES). This 10-item scale evaluates the global self-esteem of an individual (scores ranging from 10 to 40). High scores indicating high self-esteem.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in reactions after traumatic events scores

  Impact of Events Scale (IES). A 15-item scale designed to measure stress reactions after traumatic impact. A score total (ranging from 0 to 75) and 2 subscales: intrusion (ranging from 0 to 35) and avoidance (ranging from 0 to 40) can be computed. High scores indicating higher levels of intrusion and avoidance.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Childhood trauma

  Score on the Childhood Trauma Questionnaire (CTQ-SF). A 28-item questionnaire designed to assess retrospective child abuse and neglect. 5 dimensions can be computed (scores ranging from 5 to 25): physical abuse, emotional abuse, physical abuse, sexual abuse and emotional neglect. A total score can be computed by adding all items (scores ranging from 25 to 125). A score higher than 5 indicating experiences of maltreatment or abuse in childhood and youth.

  Before the treatment

• Posttraumatic stress

  Score on the Posttraumatic Stress Diagnostic Scale (PDS). A 49-item self-report measure providing an assessment of all six PTSD's criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). The nature of the event, and their frequency are evaluated with a checklist including potentially traumatizing events (frequency ranging from "never" to "3 times or more"). A symptom severity score can also be computed (scores ranging from 0 to 51). The cut offs for symptom severity rating are 0 no rating, 1-10 mild, 11-20 moderate, 21-35 moderate to severe and \>36 severe.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in cannabis abuse scores

  Score on the Cannabis Abuse Screening (CAST). A 6-item screening for the cannabis abuse or problematic patterns of cannabis use. Score total ranging from 0 to 24. High scores indicating high risk of having a cannabis use disorder.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.

• Change in coping scores

  Score of Coping Ways Checklist (WCC). 27-item questionnaire evaluating 3 coping strategies: problem-focused coping (scores ranging from 10 to 40), emotion-focused coping (scores ranging from 9 to 36), and seeking social support (scores ranging from 8 to 32). Subscales scores are computed by adding correspondent items. Higher scores indicate higher use of the coping strategy.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment (only cohorts 2, 3 and 4)

• Change in life orientation scores

  Score on the Revised Life Orientation Test (LOT-R). 10-item questionnaire evaluating individual differences in generalized optimism versus pessimism. A total score can be computed, ranging from 0 to 24. Higher total scores reflect higher levels of optimism.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment (only cohorts 3 and 4)

• Change in smartphone addiction scores

  Score on the Smartphone Addiction Scale Short Version (SAS-SV). 10-item questionnaire developed to identify maladaptive behavior associated with smartphones. The scores are ranged from 10 to 60. Higher scores meaning a higher presence of "smartphone addiction".

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment (only cohorts 3 and 4)

• Change in internet addiction scores

  Score on Internet Addiction Test (IAT). A 20-item scale developed to assess internet addiction or problematic internet use. Scores are obtained by adding all the items (ranging from 20 to 100). The higher the score, the greater the problems Internet use causes.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment (only cohorts 3 and 4)

• Changes in clients progress through the course of the therapy scores

  Score on the Outcome Questionnaire (OQ.45.2). 45-item self-report questionnaire designed for repeated measurement of client progress through the course of therapy and following termination. 3 subscales: Symptom Distress (SD): score ranging from 0 to 100, Interpersonal Relations (IR): score ranging from 0 to 44, and Social Role performance (SR): scores ranging from 0 to 36. A total score can be computed, score ranging from 0 to 180. The higher the score, the more disturbed the individual.

  Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment. At the end of each session: first session, and 1, 2, 3 , 4, 5, 6, and 7 weeks after the first session.

Secondary Outcomes (4)

• Change in ambulatory assessment scores

  Before the treatment, at the end of the treatment (at 2 months)

• Change in the answer to the reward task scores

  Before the treatment, at the end of the treatment (at 2 months)

• Change in cortisol levels in daily life

  Before the treatment, at the end of the treatment (at 2 months)

• Change in cortisol levels in laboratory task

  Before the treatment, at the end of the treatment (at 2 months)

Other Outcomes (9)

• Score in the socio-Economic Position Index (PSES)

  Before treatment

• Information about relatives

  Before treatment

• Handedness

  Before treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

Participation in a multidimensional stress prevention program (GeDStress).

Behavioral: Multidimensional stress prevention program (GeDStress)

Wait-list control group

NO INTERVENTION

Participants on the wait-list control group will not receive any treatment between the baseline and last follow-up. After the study has ended, they have the option to participate in the program.

Interventions

Multidimensional stress prevention program (GeDStress) BEHAVIORAL

The multidimensional stress prevention program (GeDStress) is composed of 8 session of 2-hour weekly sessions and integrated cognitive and behavioral strategies, mindfulness-based activities, emotional regulation and social skills exercises. Brief homework activities were given between sessions. The groups were composed by a maximum of 8 students and were led by two trained clinical psychologists.

Intervention group

Eligibility Criteria

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

You may qualify if:

• being older than 18 years old,
• having a good understanding of French or German
• being a student at the University Fribourg
• For the other parts of the study:
• \- being right-handed

You may not qualify if:

• the presence of an endocrinological condition,
• history or presence of a neurological disorder or brain injury,
• use of psychotropic drugs,
• presence of a mental disorder, and
• participating in another psychological intervention and participating in the longitudinal part of this study.
• For the other parts of the study

Sponsors & Collaborators

• Chantal Martin Soelch: lead
• University of Fribourg: collaborator
• University of Bern: collaborator

Study Sites (1)

University of Fribourg

Fribourg, 1700, Switzerland

Location

Related Publications (6)

• Regehr C, Glancy D, Pitts A. Interventions to reduce stress in university students: a review and meta-analysis. J Affect Disord. 2013 May 15;148(1):1-11. doi: 10.1016/j.jad.2012.11.026. Epub 2012 Dec 13.

  PMID: 23246209 BACKGROUND

• Dyrbye LN, Thomas MR, Shanafelt TD. Systematic review of depression, anxiety, and other indicators of psychological distress among U.S. and Canadian medical students. Acad Med. 2006 Apr;81(4):354-73. doi: 10.1097/00001888-200604000-00009.

  PMID: 16565188 BACKGROUND

• Deasy C, Coughlan B, Pironom J, Jourdan D, Mcnamara PM. Psychological distress and lifestyle of students: implications for health promotion. Health Promot Int. 2015 Mar;30(1):77-87. doi: 10.1093/heapro/dau086. Epub 2014 Oct 14.

  PMID: 25315646 BACKGROUND

• Deasy C, Coughlan B, Pironom J, Jourdan D, Mannix-McNamara P. Psychological distress and coping amongst higher education students: a mixed method enquiry. PLoS One. 2014 Dec 15;9(12):e115193. doi: 10.1371/journal.pone.0115193. eCollection 2014.

  PMID: 25506825 BACKGROUND

• Heinen I, Bullinger M, Kocalevent RD. Perceived stress in first year medical students - associations with personal resources and emotional distress. BMC Med Educ. 2017 Jan 6;17(1):4. doi: 10.1186/s12909-016-0841-8.

  PMID: 28056972 BACKGROUND

• Martin-Soelch C, Kobel M, Stoecklin M, Michael T, Weber S, Krebs B, Opwis K. Reduced response to reward in smokers and cannabis users. Neuropsychobiology. 2009;60(2):94-103. doi: 10.1159/000239685. Epub 2009 Sep 21.

  PMID: 19776653 BACKGROUND

Related Links

• Research projects University of Fribourg

MeSH Terms

Conditions

Stress, Psychological; Psychological Well-Being; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants were randomized assigned to the intervention group or the wait-list control group. The measurements were taken at the same time for both groups: before and after the intervention, and two follow-up ( at 3 and 6 months)

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: March 4, 2019
• Study Start: March 14, 2015
• Primary Completion: June 4, 2017
• Study Completion: June 4, 2017
• Last Updated: March 4, 2019

Record last verified: 2019-02

Locations

CH (1)