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The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor

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ClinicalTrials.gov Identifier: NCT02848014
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date April 6, 2017
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Change in personal control expectation (Item of the Brief IPQ) [ Time Frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02848014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Change in emotions (PANAS) [ Time Frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1) ]
  • Subjective stress ratings [ Time Frame: directly after completing the stress induction (approximately 50 minutes after baseline assessment; T2) ]
    Questionnaire items
  • Change in Cortisol levels (saliva sample) [ Time Frame: Pre-intervention (baseline; T0) vs.Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction ]
    directly (T2), 15 min (T3) and 30 min (T4) after stress induction = 50 min, 65 min and 80 min after baseline assessment
  • Change in Alpha-Amylase levels (saliva sample) [ Time Frame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction ]
    directly (T2), 15 min (T3) and 30 min (T4) after stress induction = 50 min, 65 min and 80 min after baseline assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor
Official Title  ICMJE The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor on Subjective and Objective Stress Paramaters
Brief Summary The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Furthermore, the investigators will examine whether both interventions are effective in buffering the stress response after an acute stressor in a healthy sample compared to a control condition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE Behavioral: Writing task
Study Arms  ICMJE
  • Experimental: Expectation
    Participants are asked to think and write about ways how they can positively influence/control the stress during stress induction. They also can think of strategies they used in their past. The purpose of this arm is to improve participants' personal control expectations.
    Intervention: Behavioral: Writing task
  • Experimental: Emotion
    Participants in this group are asked to write a gratitude-letter to a person they want to thank. The purpose of this arm is to foster positive emotions.
    Intervention: Behavioral: Writing task
  • Active Comparator: Control
    Participants in this group are asked to do a neutral writing task. The task is to write a protocol of yesterday's to-dos.
    Intervention: Behavioral: Writing task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
74
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
66
Actual Study Completion Date  ICMJE November 30, 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • fluent in German language

Exclusion Criteria:

  • chronic disease
  • mental disease
  • the evening before the day of the experiment until end of the experiment (the next day): caffeine, alcohol, intensive physical exercise, chewing gum
  • acute hay fever
  • current intake of psychotropic medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848014
Other Study ID Numbers  ICMJE 2016-08k
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Winfried Rief, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Winfried Rief, Professor Philipps University Marburg Medical Center
PRS Account Philipps University Marburg Medical Center
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP