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Completed

NCT Number: 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:

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruhr-University Bochum

Bochum, North Rhine-Westphalia, 44801, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

PoET

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Socio-demographic data

    Time frame: before 1st training session

    age, gender, marital status, education, employment

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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