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临床试验/NCT03861013
NCT03861013已完成不适用

Reward Under Stress: Psychobiological Mechanisms of Resilience to Stress

Chantal Martin Soelch2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Change in quality of life scores

研究概览

简要总结

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

详细描述

University students report increased levels of stress in comparison to the general population of the same age, and that may be associated with an increased risk for psychological problems. Depression, anxiety, substance abuse, sleep- and eating problems are often reported by university students. The effectiveness of cognitive, behavioral, and mindfulness interventions focusing on stress prevention among university students was evidenced. However, these programs are generally based on one way to cope with stress. This study is part of a large three-part study and aimed to investigate the impact of a multidimensional stress prevention program on stress, quality of life, psychological and physical indicators, and also psychological resources in university students. The investigators also aimed to study the impact of the intervention on stress and reward experiences in daily life and reward responses under stress in an experimental task.

A randomized controlled trial study was applied to compare pre- and post-outcomes in an experimental group compared to a wait-list control group. Sixty-four university students were randomly distributed in both groups. The experimental group followed an eight-week stress prevention program (GeDStress), integrating cognitive-behavioral strategies with mindfulness-based exercises, emotional regulation strategies, social skills training and assertiveness activities. This program aims at stress reduction and resilience strategies' increase.

The study protocol was accepted by the Ethics Committee of the Cantons of Vaud and Fribourg (Protocol 261/14) and followed the ethical principles of the Declaration of Helsinki (World Medical Association, 2013) and the local regulatory law. Confidentiality was guaranteed and participants could withdraw from the study at any time. All data collected were deidentified with a code. All participants signed the written informed consent.

Before (T1) and after (T2) the participation in the program, both groups participated to a structured interview, which took between 30 and 60 minutes. After that, participants answered well-validated self-reported online questionnaires about their psychological and physical well-being in French. A link with the questionnaires were sent by email and participants had to complete them during the following days. Participants separately received their code number and needed approximately one hour to answer the questionnaires.

At T1 and T2, the students realized also an ambulatory assessment to evaluate their stress and reward experiences in daily life. Participants' stress and reward experience in the daily living environment were assessed five times a day during one week using an adaptation of the Experience Sampling Method (ESM), using an electronic assessment tool. Subjects were asked to report the most important event that happened between the current and the previous measurement and they were then asked to appraise the current situation, their mood, the minor daily events, the related positive and negative affects as well as stress-related experience. In parallel, saliva samples were collected six times a day in order to determine cortisol levels in saliva, to measure the objective level of stress and to combine reported subjective stress with the physiological measures of stress. Saliva samples were obtained by spitting in a tube, and collected saliva samples were stored at -20°C in a deep freeze at the Department of Psychology of the University Fribourg until to be sent to the laboratory for the analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • general MRI exclusion criteria, i.e. presence of claustrophobia, being pregnant (tested with a pregnancy test), metal in the body (pacemakers, aneurysm's clips, metallic prosthesis, cochlear implant...).

研究组 & 干预措施

Intervention group

Experimental

Participation in a multidimensional stress prevention program (GeDStress).

干预措施: Multidimensional stress prevention program (GeDStress) (Behavioral)

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.

结局指标

主要结局

Change in quality of life scores

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

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.

Change in depression scores

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

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.

Change in burnout scores

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

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.

Change in social anxiety scores

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

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.

Change in anxiety trait and state scores

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

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.

Change in self-esteem scores

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

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.

Change in sense of coherence scores

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

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.

Change in difficulties in emotion regulation scores

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

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.

Change in symptoms of mental health scores

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

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.

Change in general self-efficacy scores

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

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.

Change in mindfulness skills scores

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

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).

Change in self-compassion scores

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

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.

Change in perceived social support scores

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

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.

Change in reactions after traumatic events scores

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

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.

Change in smartphone addiction scores

时间窗: 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)

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".

Change in internet addiction scores

时间窗: 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)

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.

Changes in clients progress through the course of the therapy scores

时间窗: 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.

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.

Change in perceived stress scores

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

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).

Change in cannabis abuse scores

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

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.

Change in life orientation scores

时间窗: 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)

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.

Change in reward responsiveness scores

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

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.

Posttraumatic stress

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

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.

Change in coping scores

时间窗: 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)

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.

Childhood trauma

时间窗: Before the treatment

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.

次要结局

  • 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 ambulatory assessment scores(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))

研究者

发起方
Chantal Martin Soelch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chantal Martin Soelch

Professor

University of Fribourg

研究点 (2)

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