- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06851637
Reducing Symptoms of Depression, Stress and Anxiety and Enhancing Positive Mental Health: a Randomized-controlled Study of the Positive Emotions Training
Based on the results of the previously published paper "Positive Emotions Training (PoET) as an online intervention to improve mental health: a feasibility study" (Niemann et al., 2023) the goal of this study was to examine the effects of the "Positive Emotions Training" on mental health in a randomized-controlled study. Furthermore, possible predictors for the efficacy of PoET are to be explored.
Hypotheses:
- It was hypothesized that participants receiving PoET would show a significant increase in positive mental health factors at the second assessment point (T2) at end of the second training day.
- Furthermore, participants receiving PoET are to be expected to show a significant decrease in depression, anxiety and stress symptoms at T2.
- It was hypothesized that the changes in mental health factors remain stable up to the last assessment point (T3) three month after the training.
- Lastly, it was hypothesized that there would be no significant changes in the positive or negative mental health factors in the control group at T2 and T3.
- The possible predictors of the training's efficacy were not hypothesized, but examined in exploratory investigations.
Methods:
The final sample was n = 207 with n = 90 in the PoET group and n = 117 in the control. The control group did not receive any intervention in the experimental period, but was offered to participate in a later PoET. The allocation was randomized. Participants in the PoET group completed two online training sessions (3 hours each) via Zoom. Group size was about 25-30 people. The sessions included the following positive psychology constructs: happiness, humour, optimism, loving kindness and gratitude on the first day, and hope, self-efficacy, meaningfulness, forgiveness and resilience on the second day. All participants completed a questionnaire at the beginning of the first training session, at the end of the second one as well as three months after the second session. Participants were given an exercise booklet for all exercises (during the training sessions and at home). The one-week break between the two sessions was advertised as a "7-day-challenge" to improve the motivation in participants to exercise at home.
Data was collected pseudonymised via "qualtrics". Data analyses were conducted with RStudio. For the possible effects of PoET on mental health two-factorial repeated measures ANOVAs were conducted. For the exploration of possible predictors for the efficacy of the training, a hierarchical regression was conducted.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Rhine-Westphalia
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Bochum, North Rhine-Westphalia, Germany, 44801
- Ruhr-University Bochum
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- legal age (18), ability to use Zoom and all associated technology
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PoET group
Participants of this arm received the PoET online training within two sessions.
They filled out a whole of three questionnaires.
|
Participants in the PoET group completed two online training sessions (3 hours each) via Zoom.
Group size was about 25-30 people.
The sessions included the following positive psychology constructs: happiness, humour, optimism, loving kindness and gratitude on the first day, and hope, self-efficacy, meaningfulness, forgiveness and resilience on the second day.
|
|
No Intervention: Control group
Participants did not receive any treatment initially, but were offered to participate in a later PoET training as compensation.
They filled out a whole of three questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Mental Health Scale (PMH)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
9 items, 4-point-scale from 0 ("I do not agree ") to 3 ("I agree"), assessing emotional and psychological aspects of wellbeing, higher scores reflect better positive mental health
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Depression Anxiety Stress Scale 21 (DASS-21)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
21 items, 4-point-scale from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"), assessing negative emotional states, higher scores reflect more symptoms of depression, anxiety and stress
|
before 1st and after 2nd training session, three months after 2nd training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life Orientation Test revised (LOT-r)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
10 items, 5-point-scale from 0 ("strongly disagree") to 4 ("strongly agree"), assessing dispositional optimism, higher scores reflect higher dispositional optimism
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Satisfaction with Life Scale (SWLS)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
5 items, 7-point-scale from 1 ("strongly disagree") to 7 ("strongly agree"), assessing global subjective happiness, higher scores indicate a happier person
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Brief Resilience Scale (BRS)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
6 items, 5-point-scale from 1 ("strongly disagree") to 5 ("strongly agree"), assessing participants' ability to recover from stress despite significant adversity, higher scores reflect higher resilience
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Perceived Stress Questionnaire (PSQ)
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
20 items, 4-point-scale from 1 ("almost never") to 4 ("usually"), assessing the perceived stress in different areas of life, higher scores indicate more stress
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Satisfaction in different areas of life
Time Frame: before 1st and after 2nd training session, three months after 2nd training session
|
self-generated, five items, 4-point-scale from 1 ("not satisfied") to 4 ("satisfied"), assessing participants satisfaction in five different areas of life, higher scores reflecting higher satisfaction
|
before 1st and after 2nd training session, three months after 2nd training session
|
|
Implementation of at-home exercices
Time Frame: after 2nd training session and three months after 2nd training session
|
self-generated, two questions regarding the frequency and the kind of exercise participants did at home
|
after 2nd training session and three months after 2nd training session
|
|
Socio-demographic data
Time Frame: before 1st training session
|
age, gender, marital status, education, employment
|
before 1st training session
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christina Bartnick (born Totzeck), PhD, Ruhr-University Bochum
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PoET102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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