NCT02848014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

April 6, 2017

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 29, 2016

Last Update Submit

April 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in personal control expectation (Item of the Brief IPQ)

    Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)

Secondary Outcomes (4)

  • Change in emotions (PANAS)

    Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)

  • Subjective stress ratings

    directly after completing the stress induction (approximately 50 minutes after baseline assessment; T2)

  • Change in Cortisol levels (saliva sample)

    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

  • Change in Alpha-Amylase levels (saliva sample)

    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

Study Arms (3)

Expectation

EXPERIMENTAL

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.

Behavioral: Writing task

Emotion

EXPERIMENTAL

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.

Behavioral: Writing task

Control

ACTIVE COMPARATOR

Participants in this group are asked to do a neutral writing task. The task is to write a protocol of yesterday's to-dos.

Behavioral: Writing task

Interventions

Writing taskBEHAVIORAL
ControlEmotionExpectation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fluent in German language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

Study Officials

  • Winfried Rief, Professor

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 30, 2016

Last Updated

April 6, 2017

Record last verified: 2016-06

Locations