Clinical trial NCT06851637: Reducing Symptoms of Depression, Stress and Anxiety and Enhancing Positive Mental Health: a Randomized-controlled Study of the Positive Emotions Training
Official title: Reducing Symptoms of Depression, Stress and Anxiety and Enhancing Positive Mental Health: a Randomized-controlled Study of the Positive Emotions Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive Emotions
Mental Health
Intervention (Training) Condition
Randomized Controlled Study
General Population (no Specific Condition or Disease)
Keywords: positive emotions
online intervention
positive psychology
randomized controlled study
intervention
general population
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. Furthermore, participants receiving PoET are to be expected to show a significant decrease in depression, anxiety and stress symptoms at T2.
3. It was hypothesized that the changes in mental health factors remain stable up to the last assessment point (T3) three month after the training.
4. 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.
5. 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.


Eligibility criteria: Inclusion Criteria:

* legal age (18), ability to use Zoom and all associated technology

Exclusion Criteria:

* none

Primary outcomes:
measure: Positive Mental Health Scale (PMH)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Depression Anxiety Stress Scale 21 (DASS-21)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
Secondary outcomes:
measure: Life Orientation Test revised (LOT-r)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Satisfaction with Life Scale (SWLS)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Brief Resilience Scale (BRS)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Perceived Stress Questionnaire (PSQ)
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Satisfaction in different areas of life
timeFrame: before 1st and after 2nd training session, three months after 2nd training session
measure: Implementation of at-home exercices
timeFrame: after 2nd training session and three months after 2nd training session
measure: Socio-demographic data
timeFrame: before 1st training session
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr-University Bochum
state: North Rhine-Westphalia
Study officials:
affiliation: Ruhr-University Bochum
name: Christina Bartnick (born Totzeck), PhD
role: STUDY_DIRECTOR
References:
citation: Niemann L, von Gruner C, Zhang XC, Margraf J, Totzeck C. Positive Emotions Training (PoET) as an online intervention to improve mental health: a feasibility study. BMC Public Health. 2023 Aug 14;23(1):1543. doi: 10.1186/s12889-023-16424-x.