no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing)NCT04461548
Micro-interventions Aiming to Optimize Expectations or Self-compassion to Improve Well-being/Reduce Stress and Their Differential Effects
A study testing Thinking, writing and imagining in people with no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing), run by Philipps University Marburg at 1 site in Germany.
Trial summary
The study's aim is to determine whether brief interventions (micro-interventions) aiming to optimize expectations or enhancing feelings of self-compassion are able to improve well-being/reduce perceived stress in comparison to an active control group in an online-study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing)
- What is being tested?
- Thinking, writing and imagining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2020to 19 Oct 2020
- 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
- fluent in German language
- access to a computer/tablet/smartphone with audio output/headphones
Who cannot join
- not willing to take part in an online-intervention (duration: 60 minutes)
- no access to a computer/tablet/smartphone with audio output/headphones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-interventions Aiming to Optimize Expectations or Self-compassiong and Their Differential Effects
The study's aim is to determine whether brief interventions (micro-interventions) aiming to optimize expectations or enhancing feelings of self-compassion are able to improve well-being/reduce perceived stress in comparison to an active control group in an online-study
Read the detailed description
In this study we use a pre-post-test design to compare the effects of the (classic) best possible self intervention vs. the best possible self intervention (including ways on how to reach the imagined best possible future) vs. a self-compassion intervention vs. an active control group. We are interested in the differential effects and examine several moderators.
- Being tested
- Thinking, writing and imagining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking, writing and imaginingBehavioural
All participants are asked to take some time to think and write about the content of the respective intervention group. After the writing exercise (approx. 15-20 min) participants are asked to imagine that content for about 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1: Best Possible Self | Experimental | Participants are asked to think and write about their best possible future self and to imagine this positive future subsequently. Receives: Behavioral: Thinking, writing and imagining |
| Experimental group 2: Best Possible Self + next steps | Experimental | Participants are asked to think and write about their best possible future self and what the next steps could be to reach that best possible future. Subsequently, participants are asked to imagine this positive future. Receives: Behavioral: Thinking, writing and imagining |
| Experimental group 3: Self-compassion | Experimental | Participants are asked to think and write about a self-compassion exercise and to imagine this content subsequently. Receives: Behavioral: Thinking, writing and imagining |
| Active control group | Active comparator | Participants are asked to think and write about a neutral task that is comparable to the experimental groups. Receives: Behavioral: Thinking, writing and imagining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress ratings
Participants are asked to rate how stressed they feel at the moment at two time points (baseline and the intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
e.g.Lesage, F.-X., Berjot, S., \& Deschamps, F. (2012). Clinical stress assessment using a visual ana-logue scale. Occupational Medicine, 62(8), 600-605. https://doi.org/10.1093/occmed/kqs140
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Secondary outcomes (8)
Change in perceived (stress) burden ratings (resulting from perceived stress)
Participants are asked to rate how burdened they feel at the moment at two time points (baseline and the intervention) due to the experienced stress on a questionnaire (VAS: item ranges from 0 (not at all) - 100 (very much). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). Indirect/opposite measure of well-being.
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in emotions (PANAS)
Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
Krohne, H.W., Egloff, B., Kohlmann, C.W., \& Tausch, A. (1996). Experiments with a German version of the "Positive and Negative Affect Schedule (PANAS). Diagnostica, 42, 139-156.
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in state optimism ratings
State Optimism measure (SOM), 7 items (each item 1(strongly disagree)-5(strongly agree)). Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate). Millstein, R. A., Chung, W. J., Hoeppner, B. B., Boehm, J. K., Legler, S. R., Mastromauro, C. A., \& Huffman, J. C. (2019). Development of the State Optimism Measure. General hospital psychiatry, 58, 83-93
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in state self-compassion
Change in state self-compassion (SCS-state), 16 items (each item 1(strongly disagree) - 5 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
Breines, J. G., \& Chen, S. (2013). Activating the inner caregiver: The role of support-giving schemas in increasing state self-compassion. Journal of Experimental Social Psychology, 49(1), 58-64. https://doi.org/10.1016/j.jesp.2012.07.015
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Satisfaction ratings with the respective intervention
e.g. "I was satisfied with the intervention" or "I feel like I had a benefit from this intervention"
Measured: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
Ratings directly assessing the perceived change due to the intervention
e.g. "The intervention reduced my perceived stress", "The intervention increased my feeling of being able to influence things"
Measured: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
Change in perceived self-efficacy (expectations)
Change in perceived self-efficacy (SWE), 10 items (each item (1(not at all) - 4(exactly)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
SchwarzerR\& Jerusalem M. Generalized Self---Efficacy scale. In J. Weinman, S. Wright, \&M. Johnston, Measures in health psychology: A user's portfolio. Causal andcontrol beliefs (pp. 35---37). 1995. Windsor, England: NFER---NELSON.
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in anxiety and depression state (STADI)
Change in anxiety and depression state (STADI), 20 items (each item 1(strongly disagree) - 4 (strongly agree)). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate).
Laux, L., Hock, M., Bergner-Köther, R., Hodapp, V., \& Renner, K. H. (2013). The State-Trait-Anxiety-Depression-Inventory-Manual. Göttingen, Germany: Hogrefe.
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start6 Jun 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461548
- Sponsor's protocol ID
- Micro_expect_compass
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-interventions Aiming to Optimize Expectations or Self-compassiong and Their Differential Effects
- ClinicalTrials.gov ID
- NCT04461548
- Acronym / sponsor ID
- Micro_expect_compass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 8 Jul 2020 (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 study's aim is to determine whether brief interventions (micro-interventions) aiming to optimize expectations or enhancing feelings of self-compassion are able to improve well-being/reduce perceived stress in comparison to an active control group in an online-study
Detailed description
In this study we use a pre-post-test design to compare the effects of the (classic) best possible self intervention vs. the best possible self intervention (including ways on how to reach the imagined best possible future) vs. a self-compassion intervention vs. an active control group. We are interested in the differential effects and examine several moderators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1: Best Possible Self | Experimental | Behavioral: Thinking, writing and imaginingParticipants are asked to think and write about their best possible future self and to imagine this positive future subsequently. |
| Experimental group 2: Best Possible Self + next steps | Experimental | Behavioral: Thinking, writing and imaginingParticipants are asked to think and write about their best possible future self and what the next steps could be to reach that best possible future. Subsequently, participants are asked to imagine this positive future. |
| Experimental group 3: Self-compassion | Experimental | Behavioral: Thinking, writing and imaginingParticipants are asked to think and write about a self-compassion exercise and to imagine this content subsequently. |
| Active control group | Active comparator | Behavioral: Thinking, writing and imaginingParticipants are asked to think and write about a neutral task that is comparable to the experimental groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fluent in German language
- access to a computer/tablet/smartphone with audio output/headphones
Key exclusion criteria (2 listed)
- not willing to take part in an online-intervention (duration: 60 minutes)
- no access to a computer/tablet/smartphone with audio output/headphones
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 |
|---|---|---|
| Thinking, writing and imaginingAll participants are asked to take some time to think and write about the content of the respective intervention group. After the writing exercise (approx. 15-20 min) participants are asked to imagine that content for about 5 minutes. | Behavioural | Active control group, Experimental group 1: Best Possible Self, Experimental group 2: Best Possible Self + next steps, Experimental group 3: Self-compassion |
Primary outcome
Change in perceived stress ratings
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Participants are asked to rate how stressed they feel at the moment at two time points (baseline and the intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores; pre-scores will be used as a covariate). e.g.Lesage, F.-X., Berjot, S., \& Deschamps, F. (2012). Clinical stress assessment using a visual ana-logue scale. Occupational Medicine, 62(8), 600-605. https://doi.org/10.1093/occmed/kqs140
8 secondary outcomes
Change in perceived (stress) burden ratings (resulting from perceived stress)
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in emotions (PANAS)
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in state optimism ratings
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in state self-compassion
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Satisfaction ratings with the respective intervention
Time frame: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
Ratings directly assessing the perceived change due to the intervention
Time frame: Only Post-Assessment (end of the experiment; approx. 45-60 minutes after start of the experiment)
Change in perceived self-efficacy (expectations)
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in anxiety and depression state (STADI)
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
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 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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 Thinking, writing and imagining in people with no Specific Clincal Condition Required (Focus is on Persons Who Are Feeling Stressed or Want to Improve Their Wellbeing), run by Philipps University Marburg at 1 site in Germany.
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 2 inclusion and 2 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 7 Aug 2024. 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 Germany. 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 perceived stress ratings (time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.