Stress, PsychologicalNCT03861013
Reward Under Stress: Effects of a Multidimensional Stress Prevention Program in University Students
A study testing Multidimensional stress prevention program (GeDStress) in people with Stress, Psychological, run by Chantal Martin Soelch at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Multidimensional stress prevention program (GeDStress)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Mar 2015to 4 Jun 2017
- 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
- 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
Who cannot join
- 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…).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reward Under Stress: Psychobiological Mechanisms of Resilience to Stress
The purpose of this study is to investigate the effects of a multidimensional stress prevention program on psychological and physiological indicators among university students.
Read the detailed description
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.
Before and after, the participants also took part in an experimental task to evaluate the reward under stress. The subjects performed the Fribourg reward task developed by Martin-Soelch et al. (2009) to measure reward under a moderate psychological stress. The task comprises two levels of difficulty, which are differentiated through the number of items (3 or 7) to be remembered. The subjects saw first see a fixation cross, followed by the display of the cue about the level of difficulty and whether they can earn money or not during the trial for 1500 ms. After the cue, the subjects saw a fixation cross for 500 ms and then, an array of yellow circles (3 or 7) was displayed for 1500 ms. After a delay, during which a fixation cross was displayed on the screen for 3000 ms, a green circle was presented at any position on the screen for 1500 ms. The subjects had to decide as quickly as possible whether this circle was at the same position as one of the circle presented previously. After the response time has elapsed, the circle disappeared. Half the time, a fixation cross was displayed on the screen for 2000 ms. In the rewarded condition, a feedback about the win and about the cumulated amount of earned money appeared for 1000 ms followed by the balance account for 1000 ms. In the non-rewarded condition, a blank screen was displayed. During the rewarded condition, the subjects could earn a monetary reward. The amount of the monetary reward that could be won varied between two conditions, a low monetary reward consisting in CHF 0.10 or a high monetary reward consisting in CHF 1. The subjects were instructed that they would receive the sum shown at the end of the experiment. The subjects were asked to rate their mood with a visual analog scale in regular intervals. The induction of moderate stress and to evaluate the effects of stress on physiology and brain activation would involve unpredictable mild electric shock induction during the task. At the beginning of each block, the subjects were informed if electric stimulation would be given during the block. In the second block, the electric stimulation can happen at any moment of the trial in an unpredictable fashion for the participant. The intensity of the electric shock was determined before the experiment with each subject individually, to make sure that the intensity of the shock was under the individual pain threshold. In order to measure the level of stress, saliva samples were collected before and after each block (condition), and 10 and 20 minutes after the end of the task, in order to determine cortisol levels in saliva during the different conditions of the task.
Two follow-up sessions were composed by the online self-reported questionnaires, and were measured in both groups at 3 (T3) and 6 (T4) months after the end of the intervention.
- Conditions
- Stress, Psychological
- Being tested
- Multidimensional stress prevention program (GeDStress)
- 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
- Medical subject headings
- Stress, Psychological, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional stress prevention program (GeDStress)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participation in a multidimensional stress prevention program (GeDStress). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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
Scores in the 67-item ambulatory assessment. It evaluates stressful situations and their effects on daily life. Items can be evaluated alone or combined in some indicators: context information; mood (scores 1-8; valence, energic arousal, calmness); affective states (positive/negative: mean, scores: 1-7); subjective stress (scores 0-9); daily hassles (positive/negative events, frequency : 1-7); perceived support (mean, scores: 1-7. Be appreciated, understood and perceived support); psychological needs: autonomy, competence, and relatedness (mean, scores: 0-6. General score); activity appraisal (scores: 1-7, 0-9. Stress- or event-related score); activity/events appraisal (scores: 0-7. Dimensions: control, novelty and skill); reward experiences (criticism or compliments. Reward expectation: extrinsic, introjected, identified, and intrinsic); emotion regulation (reappraisal and expressive suppression); thoughts; coping strategies; engagement in pleasant activities; and self-esteem.
Measured: Before the treatment, at the end of the treatment (at 2 months)
Change in the answer to the reward task scores
Scores on the laboratory reward task under stress. The Fribourg reward task is a spatial delayed response task to measure reward under stress, with two levels of difficulty to be remembered: 3 items (low) and 7 (high). First, an array of yellow circles (3 /7) are displayed, then one green circle is presented, and participants have to decide as quickly as possible whether this circle is at the same position as one of the previous circles. Reward is also evaluated by two conditions, participants receive money or not during the trial (non-reinforced or reinforced trials). The amount varies between 2 conditions: low (CHF 0.10) or high reward (CHF 1) (up to CHF 52.80). Participants perform the task twice, in the first (control condition), no stressor was included, in the second, a moderate stress was induced through the administration of six unpredictable mild electric shocks. Early in each block, participants are informed if electric stimulation is given, and the intensity of the electric
Measured: Before the treatment, at the end of the treatment (at 2 months)
Change in cortisol levels in daily life
Cortisol levels during the ambulatory assessment
Measured: Before the treatment, at the end of the treatment (at 2 months)
Change in cortisol levels in laboratory task
Cortisol levels during the laboratory task under stress
Measured: Before the treatment, at the end of the treatment (at 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start14 Mar 2015
- Primary completion4 Jun 2017
- Study completion4 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chantal Martin Soelch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Fribourg, University of Bern
- Responsible party
- Sponsor-investigator, Chantal Martin Soelch, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861013
- Sponsor's protocol ID
- Reward_Stress
- Other IDs
- Project 6239
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will depend of the guidelines of the journal in which published
Publications
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.
PubMed 23246209Dyrbye 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.
PubMed 16565188Deasy 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.
PubMed 25315646Deasy 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.
PubMed 25506825Heinen 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.
PubMed 28056972Martin-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.
PubMed 19776653
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Under Stress: Psychobiological Mechanisms of Resilience to Stress
- ClinicalTrials.gov ID
- NCT03861013
- Acronym / sponsor ID
- Reward_Stress
- Conditions
- Stress, Psychological
- Keywords
- Stress management, Intervention program, University students, Perceived stress, Mental health, Anxiety, Depression, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chantal Martin SoelchUniversity, hospital or other
- Collaborators
- University of Fribourg, University of Bern
- Study start
- 14 Mar 2015 (actual)
- Primary completion
- 4 Jun 2017 (actual)
- Study completion
- 4 Jun 2017 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of a multidimensional stress prevention program on psychological and physiological indicators among university students.
Detailed description
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.
Before and after, the participants also took part in an experimental task to evaluate the reward under stress. The subjects performed the Fribourg reward task developed by Martin-Soelch et al. (2009) to measure reward under a moderate psychological stress. The task comprises two levels of difficulty, which are differentiated through the number of items (3 or 7) to be remembered. The subjects saw first see a fixation cross, followed by the display of the cue about the level of difficulty and whether they can earn money or not during the trial for 1500 ms. After the cue, the subjects saw a fixation cross for 500 ms and then, an array of yellow circles (3 or 7) was displayed for 1500 ms. After a delay, during which a fixation cross was displayed on the screen for 3000 ms, a green circle was presented at any position on the screen for 1500 ms. The subjects had to decide as quickly as possible whether this circle was at the same position as one of the circle presented previously. After the response time has elapsed, the circle disappeared. Half the time, a fixation cross was displayed on the screen for 2000 ms. In the rewarded condition, a feedback about the win and about the cumulated amount of earned money appeared for 1000 ms followed by the balance account for 1000 ms. In the non-rewarded condition, a blank screen was displayed. During the rewarded condition, the subjects could earn a monetary reward. The amount of the monetary reward that could be won varied between two conditions, a low monetary reward consisting in CHF 0.10 or a high monetary reward consisting in CHF 1. The subjects were instructed that they would receive the sum shown at the end of the experiment. The subjects were asked to rate their mood with a visual analog scale in regular intervals. The induction of moderate stress and to evaluate the effects of stress on physiology and brain activation would involve unpredictable mild electric shock induction during the task. At the beginning of each block, the subjects were informed if electric stimulation would be given during the block. In the second block, the electric stimulation can happen at any moment of the trial in an unpredictable fashion for the participant. The intensity of the electric shock was determined before the experiment with each subject individually, to make sure that the intensity of the shock was under the individual pain threshold. In order to measure the level of stress, saliva samples were collected before and after each block (condition), and 10 and 20 minutes after the end of the task, in order to determine cortisol levels in saliva during the different conditions of the task.
Two follow-up sessions were composed by the online self-reported questionnaires, and were measured in both groups at 3 (T3) and 6 (T4) months after the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multidimensional stress prevention program (GeDStress)Participation in a 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being older than 18 years old,
- having a good understanding of French or German
- being a student at the University Fribourg
- being right-handed
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional stress prevention program (GeDStress)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. | Behavioural | Intervention group |
Primary outcome
Change in depression scores
Time frame: 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 anxiety trait and state scores
Time frame: 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 sense of coherence scores
Time frame: 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 burnout scores
Time frame: 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
Time frame: 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 quality of life scores
Time frame: 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 difficulties in emotion regulation scores
Time frame: 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 perceived stress scores
Time frame: 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 general self-efficacy scores
Time frame: 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
Time frame: 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 symptoms of mental health scores
Time frame: 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 self-compassion scores
Time frame: 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
Time frame: 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 reward responsiveness scores
Time frame: 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.
Change in self-esteem scores
Time frame: 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 reactions after traumatic events scores
Time frame: 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.
Childhood trauma
Time frame: 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.
Posttraumatic stress
Time frame: 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 cannabis abuse scores
Time frame: 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 coping scores
Time frame: 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.
Change in life orientation scores
Time frame: 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 smartphone addiction scores
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change in ambulatory assessment scores
Time frame: Before the treatment, at the end of the treatment (at 2 months)
Change in the answer to the reward task scores
Time frame: Before the treatment, at the end of the treatment (at 2 months)
Change in cortisol levels in daily life
Time frame: Before the treatment, at the end of the treatment (at 2 months)
Change in cortisol levels in laboratory task
Time frame: Before the treatment, at the end of the treatment (at 2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 23246209Regehr 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.
- Background: PubMed 16565188Dyrbye 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.
- Background: PubMed 25315646Deasy 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.
- Background: PubMed 25506825Deasy 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.
- Background: PubMed 28056972Heinen 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.
- Background: PubMed 19776653Martin-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.
- Individual participant dataSharing planned: Undecided. Will depend of the guidelines of the journal in which published
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional stress prevention program (GeDStress) in people with Stress, Psychological, run by Chantal Martin Soelch at 1 site in Switzerland.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2019. 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 Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression scores (time frame: Before the treatment, at the end of the treatment (at 2 months), at 3 and 6 months after the end of the treatment.). The study lists 24 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 NCT03861013, which also lists 6 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 4 Mar 2019.