Psychology, PositiveNCT04746274
An Online Large-group One-session Training to Enhance Positive Mental Health
A study testing Online large-group one-session multicomponent positive psychological intervention and Online large-group one-session cognitive intervention targeting dysfunctional thoughts in people with Psychology, Positive and Psychological Distress, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Current models suggest that mental health is not the mere absence of a mental disorder. Rather, mental health consists of two factors, mental disorder symptoms and positive mental health, that can be regarded as continua. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychology, Positive, Psychological Distress
- What is being tested?
- Online large-group one-session multicomponent positive psychological intervention and Online large-group one-session cognitive intervention targeting dysfunctional thoughts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 17 Oct 2021
- 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
- Aged 18 years or above
Who cannot join
- Not having the appropriate technical equipment for participation in a videoconference
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The More the Merrier and Brevity is the Soul of Wit? Efficacy of a Multicomponent Positive Psychological Intervention Conducted in an Online Large-group One-session Format
Current models suggest that mental health is not the mere absence of a mental disorder. Rather, mental health consists of two factors, mental disorder symptoms and positive mental health, that can be regarded as continua. Programmes applying interventions known from the positive psychology or positive psychotherapy framework have been shown to enhance psychological wellbeing, subjective wellbeing and to reduce depressive symptoms. However, interventions were mostly conducted in an individual or small group setting and usually consisted of more than one session. The few trainings of minimal length that were conducted in group settings only used one intervention strategy or one part of multicomponent positive psychological interventions. Therefore, the conclusions that can be drawn regarding the effectiveness of short group-interventions are limited. In this study, the investigators plan to conduct an online large-group one-session training to enhance positive mental health that comprises multiple positive psychological interventions (e.g. character strengths, positive communication, goal attainment, etc). Furthermore, an active as well as a passive (waitlist) control group are included in the study. In the active control group, dysfunctional thoughts are adressed that are known to everybody but exist in a great measure in people suffering from depressive disorders. Methods used in cognitive therapy are applied in this group. Participants will be recruited from a community sample without any inclusion criteria but being of legal age. The only exclusion criterion is not having the appropriate technical equipment for participation in a videoconference. Positive mental health as well as other constructs of mental health will be assessed before and after training and at one month and six months follow up to investigate long-term effects of the intervention.
Read the detailed description
In general, the investigators expect an increase in positive mental health in the multicomponent positive psychological intervention (MPPI) group. This effect should be present at the assessment points one month and six months after training. Furthermore, the increase in positive mental health in the MPPI group is expected to be larger than in the two control groups (cognitive intervention targeting dysfunctional thoughts [CIDT], waitlist). Furthermore, the investigators hypothesize participants to benefit from the MPPI in terms of other constructs related to mental health, i.e. self efficacy, happiness, wellbeing, positive emotions, and life satisfaction, in the long term. This increase is expected to be larger in the MPPI than in the two control groups. A decrease in depressive symptoms is hypothesized to occur in the MPPI as well as in the CIDT group.
The sample under investigation will be a community sample. All participants can attain the training for free and there is no payment for participation. One week before the first training day, the random allocation to the three groups will take place. Two days before the first training day, all participants are asked to fill out another survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out one day after, one month after and six months after the first training day. After the last assessment time point, the training for the waitlist control group will be conducted.
The target sample size is 300 participants (100 per group). The investigators will attempt to recruit more participants, assuming that not all will complete the study, especially the assessment after six months.
The investigators used the software program G*Power to conduct a power analysis. The goal was to obtain .95 power to detect a small effect size of .1 at the standard .05 alpha error probability. The investigators extended the calculated sample size of 264 participants to a target sample size of 300 participants as there was no study before that compared an online multicomponent large-group one-session training to enhance positive mental health with an online large-group one-session intervention targeting dysfunctional thoughts. Therefore, the effect size for the comparison of these two groups could be smaller than f = .1.
The primary outcome measure will be analyzed with a 3x2 repeated measures ANOVA.
For all other outcome measures, the investigators will use 3 x 4 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the three groups MPPI, CIDT and waitlist control group. The second factor is a within-subjects factor reflecting the four assessment time points two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for positive mental health, life satisfaction, affect, generalized self-efficacy, happiness, wellbeing, stress perception, positive and negative aspects of mental health, depression, anxiety and stress, social support and media-related variables. Before these analyses are carried out, correlations among the outcome measures are calculated. If outcome measures correlate significantly high (above .5), they will be first analyzed together in a between-within repeated measures MANOVA to control for alpha-error accumulation. After that, the separate analyses will be conducted. Furthermore, there will be paired comparisons between each of the three groups, reducing the first between-subjects factor in the between-within rm(M)ANOVA to two levels. For each group, rmANOVAs will be conducted to analyze the change of outcome variables over time entailing paired contrasts between the assessment time points.
- Conditions
- Psychology, Positive, Psychological Distress
- Being tested
- Online large-group one-session multicomponent positive psychological intervention, Online large-group one-session cognitive intervention targeting dysfunctional thoughts
- Keywords
- large-group intervention, one-session intervention, positive mental health, positive psychological intervention, positive psychology, wellbeing, online intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online large-group one-session multicomponent positive psychological interventionBehavioural
The intervention is aimed at enhancing positive mental health by using components from positive psychology or positive psychotherapy. These include for exapmle using character strengths, savoring the moment, goal setting and goal attainment. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
Online large-group one-session cognitive intervention targeting dysfunctional thoughtsBehavioural
The intervention is aimed at reducing dysfunctional thoughts by applying strategies known from the cognitive therapy of depression. These include for example identification of automatic thoughts and cognitive biases as well as evaluating evidence for and against automatic thoughts. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
| Study group | Role | What they receive |
|---|---|---|
| Online large-group one-session multicomponent positive psychological intervention | Experimental | Not described Receives: Behavioral: Online large-group one-session multicomponent positive psychological intervention |
| Online large-group one-session cognitive intervention targeting dysfunctional thoughts | Active comparator | Not described Receives: Behavioral: Online large-group one-session cognitive intervention targeting dysfunctional thoughts |
| Waitlist Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
9 items, 4-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention and one month after the intervention
Secondary outcomes (13)
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
9 items, 4-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999)
10 items, 4-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011)
5 items, 7-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on subjective happiness scale (Lyubomirsky & Lepper, 1999; german version)
4 items, 7-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on positive and negative affect schedule (german version; Breyer & Bluemke, 2016)
20 items, 5-point Likert scale, two subscales negative affect: large change in a negative direction means better outcome positive affect: large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change in the degree of subjectively experienced stress concerning a specific situation measured with the questionnaire "primary appraisal secondary appraisal" (PASA; german version; Gaab, 2009)
The questionnaire assesses the two processes proposed in Lazarus' transactional model of stress: primary appraisal and secondary appraisal. Each process is operationalized by two subscales (yielding four level 1 subscales and two level 2 subscales). The subscales will be analyzed seperately and a stressindex will be calculated by calculating the difference between primary and secondary appraisal.
16 items, 6-point Likert-scale, for the stressindex, large changes in a negative direction mean better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on mental health continuum - short form (Keyes et al., 2008; german translation)
14 items, 6-point Likert scale, three subscales emotional wellbeing, subjective wellbeing and personal wellbeing, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on general health questionnaire (german version; Linden et al., 1996)
12 items, 4-point Likert scale, large change in a negative direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on depression anxiety stress scale (DASS-21; german version; Nilges & Essau, 2015)
21 items, 4-point Likert scale, 3 subscales that are analyzed separately (depression, anxiety, stress), large change in a negative direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief form of the perceived social support questionnaire (german version; Lin, Hirschfeld, & Margraf, 2019)
6 items, 5-point Likert scale, large change in a positive direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of frequency of media use (TV, internet, gaming, smartphone, social media)
7-point scale for each medium, large change in a negative direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of use of social media (frequency of social media use of different platforms, e.g. facebook, tumblr; accesses per day; time per day)
frequency: 7-point scale, accesses per day and time per day measured continously, large change in a negative direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief version of the Bergen Social Media Addiction Scale (german version; Brailovskaia, Schillack, & Margraf, 2020)
6 items, 5-point Likert scale, large change in a negative direction means better outcome
Measured: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion17 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychology, PositiveStudies 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
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svenja Schaumburg, Ruhr University of Bochum
- Investigators
- Svenja Schaumburg, M. Sc., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746274
- Sponsor's protocol ID
- 683
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The More the Merrier and Brevity is the Soul of Wit? Efficacy of a Multicomponent Positive Psychological Intervention Conducted in an Online Large-group One-session Format
- ClinicalTrials.gov ID
- NCT04746274
- Acronym / sponsor ID
- 683
- Conditions
- Psychology, Positive, Psychological Distress
- Keywords
- large-group intervention, one-session intervention, positive mental health, positive psychological intervention, positive psychology, wellbeing, online intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 9 Feb 2021 (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.
Current models suggest that mental health is not the mere absence of a mental disorder. Rather, mental health consists of two factors, mental disorder symptoms and positive mental health, that can be regarded as continua. Programmes applying interventions known from the positive psychology or positive psychotherapy framework have been shown to enhance psychological wellbeing, subjective wellbeing and to reduce depressive symptoms. However, interventions were mostly conducted in an individual or small group setting and usually consisted of more than one session. The few trainings of minimal length that were conducted in group settings only used one intervention strategy or one part of multicomponent positive psychological interventions. Therefore, the conclusions that can be drawn regarding the effectiveness of short group-interventions are limited. In this study, the investigators plan to conduct an online large-group one-session training to enhance positive mental health that comprises multiple positive psychological interventions (e.g. character strengths, positive communication, goal attainment, etc). Furthermore, an active as well as a passive (waitlist) control group are included in the study. In the active control group, dysfunctional thoughts are adressed that are known to everybody but exist in a great measure in people suffering from depressive disorders. Methods used in cognitive therapy are applied in this group. Participants will be recruited from a community sample without any inclusion criteria but being of legal age. The only exclusion criterion is not having the appropriate technical equipment for participation in a videoconference. Positive mental health as well as other constructs of mental health will be assessed before and after training and at one month and six months follow up to investigate long-term effects of the intervention.
Detailed description
In general, the investigators expect an increase in positive mental health in the multicomponent positive psychological intervention (MPPI) group. This effect should be present at the assessment points one month and six months after training. Furthermore, the increase in positive mental health in the MPPI group is expected to be larger than in the two control groups (cognitive intervention targeting dysfunctional thoughts [CIDT], waitlist). Furthermore, the investigators hypothesize participants to benefit from the MPPI in terms of other constructs related to mental health, i.e. self efficacy, happiness, wellbeing, positive emotions, and life satisfaction, in the long term. This increase is expected to be larger in the MPPI than in the two control groups. A decrease in depressive symptoms is hypothesized to occur in the MPPI as well as in the CIDT group.
The sample under investigation will be a community sample. All participants can attain the training for free and there is no payment for participation. One week before the first training day, the random allocation to the three groups will take place. Two days before the first training day, all participants are asked to fill out another survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out one day after, one month after and six months after the first training day. After the last assessment time point, the training for the waitlist control group will be conducted.
The target sample size is 300 participants (100 per group). The investigators will attempt to recruit more participants, assuming that not all will complete the study, especially the assessment after six months.
The investigators used the software program G*Power to conduct a power analysis. The goal was to obtain .95 power to detect a small effect size of .1 at the standard .05 alpha error probability. The investigators extended the calculated sample size of 264 participants to a target sample size of 300 participants as there was no study before that compared an online multicomponent large-group one-session training to enhance positive mental health with an online large-group one-session intervention targeting dysfunctional thoughts. Therefore, the effect size for the comparison of these two groups could be smaller than f = .1.
The primary outcome measure will be analyzed with a 3x2 repeated measures ANOVA.
For all other outcome measures, the investigators will use 3 x 4 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the three groups MPPI, CIDT and waitlist control group. The second factor is a within-subjects factor reflecting the four assessment time points two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for positive mental health, life satisfaction, affect, generalized self-efficacy, happiness, wellbeing, stress perception, positive and negative aspects of mental health, depression, anxiety and stress, social support and media-related variables. Before these analyses are carried out, correlations among the outcome measures are calculated. If outcome measures correlate significantly high (above .5), they will be first analyzed together in a between-within repeated measures MANOVA to control for alpha-error accumulation. After that, the separate analyses will be conducted. Furthermore, there will be paired comparisons between each of the three groups, reducing the first between-subjects factor in the between-within rm(M)ANOVA to two levels. For each group, rmANOVAs will be conducted to analyze the change of outcome variables over time entailing paired contrasts between the assessment time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online large-group one-session multicomponent positive psychological intervention | Experimental | Behavioral: Online large-group one-session multicomponent positive psychological intervention |
| Online large-group one-session cognitive intervention targeting dysfunctional thoughts | Active comparator | Behavioral: Online large-group one-session cognitive intervention targeting dysfunctional thoughts |
| Waitlist Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years or above
Key exclusion criteria (1 listed)
- Not having the appropriate technical equipment for participation in a videoconference
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 |
|---|---|---|
| Online large-group one-session multicomponent positive psychological interventionThe intervention is aimed at enhancing positive mental health by using components from positive psychology or positive psychotherapy. These include for exapmle using character strengths, savoring the moment, goal setting and goal attainment. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours. | Behavioural | Online large-group one-session multicomponent positive psychological intervention |
| Online large-group one-session cognitive intervention targeting dysfunctional thoughtsThe intervention is aimed at reducing dysfunctional thoughts by applying strategies known from the cognitive therapy of depression. These include for example identification of automatic thoughts and cognitive biases as well as evaluating evidence for and against automatic thoughts. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours. | Behavioural | Online large-group one-session cognitive intervention targeting dysfunctional thoughts |
Primary outcome
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time frame: two days before the intervention and one month after the intervention
9 items, 4-point Likert scale, large change in a positive direction means better outcome
13 secondary outcomes
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on subjective happiness scale (Lyubomirsky & Lepper, 1999; german version)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on positive and negative affect schedule (german version; Breyer & Bluemke, 2016)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change in the degree of subjectively experienced stress concerning a specific situation measured with the questionnaire "primary appraisal secondary appraisal" (PASA; german version; Gaab, 2009)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on mental health continuum - short form (Keyes et al., 2008; german translation)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on general health questionnaire (german version; Linden et al., 1996)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on depression anxiety stress scale (DASS-21; german version; Nilges & Essau, 2015)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief form of the perceived social support questionnaire (german version; Lin, Hirschfeld, & Margraf, 2019)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of frequency of media use (TV, internet, gaming, smartphone, social media)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change of use of social media (frequency of social media use of different platforms, e.g. facebook, tumblr; accesses per day; time per day)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
change on brief version of the Bergen Social Media Addiction Scale (german version; Brailovskaia, Schillack, & Margraf, 2020)
Time frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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 27 Apr 2022.
- Individual participant dataSharing planned: Yes. It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
Related trials for Psychology, Positive
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
Not yet recruiting
Effects of Positive Psychology on Hope, Gratitude, and Well-Being
Elderly, Nursing Homes
Recruiting
Testing the mHealth App Intervention for Nondaily Smokers "SiS4"
Smoking Cessation
Active, not recruiting
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
Type 1 Diabetes
Recruiting
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors
Hematopoietic Stem Cell Transplant
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.
Svenja Schaumburg, M. Sc. principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online large-group one-session multicomponent positive psychological intervention and Online large-group one-session cognitive intervention targeting dysfunctional thoughts in people with Psychology, Positive and Psychological Distress, run by Ruhr University of Bochum 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 1 inclusion and 1 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 27 Apr 2022. 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 on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015) (time frame: two days before the intervention and one month after the intervention). 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 27 Apr 2022.