Cognitive functioning and creativity in the face of personal stress in previously-depressed people
| ISRCTN | ISRCTN86314628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86314628 |
- Submission date
- 12/09/2021
- Registration date
- 20/09/2021
- Last edited
- 18/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Stressful situations are part of everyday life, and most people recover from them quite quickly. However, people with depression have more difficulties in this regard, and this also applies to previously depressed people, which makes them more vulnerable to future depression. Therefore, it is important to determine what ways of regulating negative emotions are particularly effective for them.
This study aims to examine different emotion regulation strategies related to creativity and, more specifically, to writing scenarios of future events. Besides, since creativity requires cognitive skills, the research also considers the importance of attention and memory. This study aims to recruit 120 people diagnosed with remitted depression to participate in two meetings in our lab. The goal is to find the most effective emotion regulation strategy among the three strategies studied compared in terms of improving emotional state. The study's findings should help to improve the therapeutic methods for enhancing dealing with distress and increasing resilience to depression in previously-depressed people.
Who can participate?
Adults aged 18 to 65 years, diagnosed with remission after depression, living in Poland.
What does the study involve?
Participants meet with a clinician to complete questionnaires assessing their emotions and cognitive skills. Next, within a week, they participate in an individual meeting in the lab, where they are handed a printed packet containing all materials. The researcher will be present in the room. According to the instructions they are asked to recall any of their currently stressful issues to be addressed later in the study and reflect on them. In the next step, the participants are randomly allocated to one of three groups and asked to write a scenario in the form of a sequence of events. Both of these tasks (recalling the stressful event and writing a scenario) will be accompanied by examples. Next, the participants view a nature video (15 min.) and answer a few short questions. Also, they are rating their emotions and experienced stress several times during the study. The entire lab meeting lasts about 45-60 minutes.
What are the possible benefits and risks of participating?
There is a risk that recalling a personally stressful event can cause negative emotions.
A possible benefit of participating in this study is contributing to the new scientific knowledge, which in the future can help previously depressed people. Participating in this study may also provide an opportunity to see how contemporary research is conducted in the area of clinical psychology, and then to learn about the overall results of this study. Also, as a thank you for taking part in the study, each participant receives 12 euros in the form of a gift card or a guide on depression prevention.
Where is the study run from?
The study is being run by the SWPS University of Social Sciences and Humanities (Warsaw) and takes place in the Institute of Psychiatry and Neurology (Warsaw, Poland)
When is the study starting and how long is it expected to run for?
January 2015 to May 2021
Who is funding the study?
The National Science Centre - NCN (Poland)
Who is the main contact?
Dr Anna Braniecka, abraniecka@swps.edu.pl
Contact information
Public
SWPS University of Social Sciences and Humanities
Chodakowska Street 19/31
Warsaw
PL - 03815
Poland
 ORCID ID |
0000-0003-1862-3284 |
|---|---|
| Phone | +48 696232981 |
| abraniecka@swps.edu.pl |
Scientific
SWPS University of Social Sciences and Humanities
Chodakowska Street 19/31
Warsaw
PL - 03815
Poland
| Phone | +48 696232981 |
|---|---|
| abraniecka@swps.edu.pl |
Study information
| Study design | Single-centre interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 40408 PIS.pdf |
| Scientific title | In people with remitted depression, is stress-related humor more effective than stress-unrelated humor in regulating negative emotions? What is the role of selective attention deficits in humor-based emotion regulation? |
| Study acronym | Humor and emotion regulation in depression |
| Study hypothesis | Stress-related humor is more effective than stress-unrelated humor would be effective in relation to emotions and experienced distress immediately and after a brief delay. Participants with deficient selective attention have difficulties in the application of humor and benefit more from non-humorous regulation. |
| Ethics approval(s) | Approved 12/01/2015, The USSH Ethics Committee on Ethics of Empirical Research Involving People as Research Subjects (Chodakowska Street 19/31, PL - 03815 Warsaw; +48 022 5179911; komisja_etyki_badan@swps.edu.pl), ref: 1/2015; G:2014/15/D/HS6/04991 |
| Condition | Determining effective emotion regulation strategies (stress-related humor, stress-unrelated humor, non-humorous strategy) in patients with remitted depression. |
| Intervention | Participants will take part in a double-blind laboratory experiment; it will consist of stress induction (recalling any current personally stressful issue) and emotion regulation manipulation, which will involve the use of one of the three strategies corresponding to the three conditions: stress-related humor, stress-unrelated humor, and non-humorous regulation. To induce stress, the participant will be asked to recall any of his/her own currently stressful issues (they will be presented with an example). In the next step, the participants will be randomly assigned to experimental conditions (by a computer generated random number list) and asked to produce a scenario in the form of a sequence of events. In the stress-related humor condition, the scenario will be humorous and related to one’s own stress-inducing issue; in the stress-unrelated humor condition, it will be humorous and unrelated to one’s own stressful issue; and in the non-humorous condition, it will be rational and related to one’s own stressful issue. The experimental manipulation is derived from stress management techniques. The participants will be provided with detailed guidelines and led step-by-step through the process of writing scenarios. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Positive emotions, negative emotions, and experienced distress are measured using single self-report scales, from 0 (“not at all”) to 6 (“as strong as possible”). Negative emotions and positive emotions are assessed four times: at baseline (T1), after stress induction (T2), after the emotion regulation manipulation (T3), and after 20 minutes (T4). The experienced distress is measured in T2, T3 and T4. |
| Secondary outcome measures | 1. Selective attention measured using the d2 Test of Attention (Brickenkamp & Zillmer, 1998) at the introductory stage (before experiment) 2. Invested effort measured using single self-report scale, which specifies the effort exerted for the task, from 0 (“none”) to 6 (“as much as possible”) immediately after the emotion regulation manipulation (T3) 3. Subsequent performance measured using a multiple-choice knowledge test (with eight questions about the video content) at the end of the neutral nature video the participants watched (T4). 4. Intrusive thoughts measured using self-report - how many times they thought about their stressful situation during the film. 5. manipulation check, the participants answered two questions, one about the subjective funniness of the scenario (“Does this scenario seem funny to you?”) and one about its rationality (“Does this scenario seem rational to you?”), by choosing “yes,” “sort of,” or “no.” They also specified how funny/rational the scenario was, from 0 (“not at all”) to 6 (“as funny/rational as possible”). Then, the participant reported the effort exerted for the task, from 0 (“none”) to 6 (“as much as possible”). A single assessment was conducted to measure invested effort (T3), subsequent performance (T4) and intrusive thoughts (T4). |
| Overall study start date | 01/01/2015 |
| Overall study end date | 04/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 122 |
| Participant inclusion criteria | 1. Participants from outpatient psychiatric clinics (aged 18-65) with a diagnosis of remission after a depressive episode 1.1. The diagnosis is made by a psychiatrist and confirmed via a Structured Clinical Interview (SCID I) administered by a clinical psychologist blind to the psychiatric diagnosis. 1.2. Depressive symptoms: An additional inclusion criterion is a BDI‐II score above a cut-off of 16. |
| Participant exclusion criteria | 1. History of manic or psychotic episodes, head injury, or neurological disorder 2. Current presence of eating disorders, anxiety disorders, intellectual disability, psychoactive substance use, pregnancy, or suicidal ideation |
| Recruitment start date | 05/06/2015 |
| Recruitment end date | 19/04/2021 |
Locations
Countries of recruitment
- Poland
Study participating centre
Warsaw
02-957
Poland
Sponsor information
Government
ul. Twardowskiego 16
Kraków
30-312
Poland
| Phone | +48 532 083 408 |
|---|---|
| biuro@ncn.gov.pl | |
| Website | https://www.ncn.gov.pl/ |
"ROR" |
https://ror.org/03ha2q922 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Science Centre, NCN
- Location
- Poland
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request and approval from the SWPS University of Social Sciences and Humanities (abraniecka@swps.edu.pl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/09/2021 | No | Yes | ||
| Protocol file | 01/01/2015 | 20/09/2021 | No | No | |
| Results article | 13/05/2022 | 18/07/2022 | Yes | No |
Additional files
Editorial Notes
18/07/2022: Publication reference added.
03/05/2022: The following changes were made to the trial record:
1. The acronym was added.
2. The intention to publish date was changed from 01/04/2022 to 01/06/2022.
07/10/2021: Internal review.
20/09/2021: Trial's existence confirmed by SWPS University of Social Sciences and Humanities.
