- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07611253
The Effect of Loving-Kindness Meditation on Mood and Anxiety Symptoms, Interpersonal Relationships, and Emotions: An Initial Randomized Controlled Trial With a Non-Clinical Sample of Undergraduate Women
The Effect of Loving-Kindness Meditation on Anhedonic Depressivity, Interpersonal Relationships, and Emotions.
The goal of this clinical trial was to examine the effects of Loving-Kindness Meditation (LKM) on anhedonic depressivity, interpersonal relationships (other inclusive self-concept, willingness to sacrifice, interaction quality) and emotions (positive affect, negative affect).
The second aim was to conduct exploratory analyses investigating potential mediators that help explain changes in anhedonic depressivity over the course of short-term targeted LKM.
Participants were randomly assigned to receive one week of ~5-minute daily audio recordings of Loving-Kindness Meditation or a visualization meditation, both of which were focused on a same-gender close friend. Participants completed baseline and follow-up questionnaires measuring psychological, social, and emotional variables; participants also completed daily questionnaires.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Undergraduate women were recruited via the Queen's University psychology department's subject pool (n = 222) and online advertisements (i.e., Facebook; n = 18) in 2021; written informed consent was obtained from all participants prior to any data collection.
We randomly assigned participants-via Microsoft Excel random number generation-to engage in one-week of either a targeted form of Loving-Kindness Meditation or a visualization meditation. Participants identified a specific close friend at the beginning of the study to be the target of their meditation practice. They completed baseline and one-week follow-up measures.
Audio instructions for the LKM and visualization meditation conditions were developed for this study based on those used by Seppala et al. (2014). Recordings were delivered via email. Descriptions of the conditions can be found in the Arms and Interventions sections.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ontario
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Kingston, Ontario, Kanada
- Queen's University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Participants must be enrolled as an undergraduate student
- Each Participant had to self-identify as a woman.
- Participants had to be age 18 or older.
- Participants had to have at least one close female platonic friend.
Exclusion Criteria:
- Participants did not complete at least three of seven daily meditations.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Loving-Kindness Meditation
Participants randomly assigned (via Microsoft Excel) to receive the Loving-Kindness Meditation intervention.
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Participants received a ~5 minute audio recording of Loving-Kindness Meditation Instructions everday for one week.
Recordings were delivered via email.
Meditators in both conditions were instructed to find a comfortable position, either sitting or lying down, and were then guided through some initial deep breathing.
Once relaxed, meditators in the LKM condition were asked to imagine receiving love and wishes of well-being from a close other; they were then asked to direct feelings of love and wishes of wellness to their target close friend.
After approximately 5 minutes, meditators were guided back to relaxation.
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Aktywny komparator: Visualization Meditation
Participants randomly assigned (via Microsoft Excel) to receive the Visualization Meditation active comparator condition.
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Participants received a ~5 minute audio recording of visualization Instructions everday for one week.
Recordings were delivered via email.
Meditators in both conditions were instructed to find a comfortable position, either sitting or lying down, and were then guided through some initial deep breathing.
Meditators in the visualization condition were asked to visualize specific details of their target close friend's appearance.
After approximately 5 minutes, meditators were guided back to relaxation.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Anhedonic Depressivity
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The anhedonic depression scale of the Mood and Anxiety Symptom Questionnaire (MASQ; Clark & Watson, 1991) was used to measure anhedonic depressivity.
Participants rated items of the MASQ (Clark & Watson, 1991) on a scale from 1-5 (1 = Not at All; 5 = Extremely) based on how they felt over the past week.
The anhedonic depression subscale includes 22 items (e.g., "Felt like there wasn't anything interesting or fun to do").
A mean score was calculated, with higher scores indicating more anhedonic depressivity.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Positive Affect
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The Positive Affect Negative Affect Schedule (PANAS; Watson et al., 1988) was used to measure positive affect.
The PANAS consists of 20 emotion words divided into two subscales (10 positive words and 10 negative words).
Participants rate each emotion word on a scale from 1-5 (1 = Very Slightly or Not at All; 5 = Extremely) corresponding to how they have been feeling over the past week.
The positive affect subscale contains emotion words such as: "Interested," "Excited," and "Inspired."
A mean score was calculated for use in data analyses, with higher scores indicating greater positive affect.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Willingness to Sacrifice
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The willingness to sacrifice scale is a two-item measure adapted from the Marburg Attitude Inventory for Styles of Loving (Bierhoff et al., 1993).
Participants are asked to respond to the following questions on a scale from 1-10 (1 = Not at all; 10 = Entirely): "To what extent would you be willing to sacrifice your own desires for your close friend's desires?"; and "To what extent would you leave everything else aside for your close friend?".
At baseline and follow-up, participants responded to these questions based on the previous week.
For each administration, a mean score was calculated for use in data analyses.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Other-Inclusive Self Concept
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The Inclusion of the Other in the Self Scale (IOS; Aron et al., 1992) is a one item measure composed of seven images of two increasingly overlapping circles labeled "self" and "other".
Other-inclusive self-concept was measured with a modified IOS by asking participants to think about their relationship with their chosen close friend over the past week and to indicate the diagram that best matched their perceived connection.
The IOS has convergent validity (Aron et al., 1992; Gächter et al., 2015) and discriminant validity (Aron et al., 1992) in relation to other established interpersonal closeness measures.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Interaction Quality
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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A modified version of the Rochester Interaction Record (M-RIR; based on Wheeler & Reis, 1991) was used to measure interaction quality.
The M-RIR asks participants to rate, from 1-7, the degree to which their interactions with their close other: 1) were intimate (1 = superficial; 7 = meaningful); 2) included self/other disclosure (1 = very little; 7 = a great deal); 3) were satisfying (1 = very unsatisfying; 7 = very satisfying); 4) were loving (1 = not at all loving; 7 = very loving); 5) were supportive (1 = not at all supportive; 7 = very supportive); and 6) were stressful (1 = not at all stressful; 7 = very stressful; reverse coded).
At baseline and follow-up, participants completed the M-RIR for the past week.
A mean score was calculated for use in data analyses, with higher scores indicating greater interaction quality.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Anxious Arousal
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The anxious arousal subscale of the Mood and Anxiety Symptom Questionnaire (MASQ; Clark & Watson, 1991) was used to measure anxious arousal. Participants rated items of the MASQ (Clark & Watson, 1991) on a scale from 1-5 (1 = Not at All; 5 = Extremely) based on how they felt over the past week. The anxious arousal subscale includes 17 items (e.g., "Was trembling or shaking"). For each subscale, a mean score was calculated, with higher scores indicating more anxious arousal. |
Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Negative Affect
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The Positive Affect Negative Affect Schedule (PANAS; Watson et al., 1988) was used to measure negative affect.
The PANAS consists of 20 emotion words divided into two subscales (10 positive words and 10 negative words).
Participants rate each emotion word on a scale from 1-5 (1 = Very Slightly or Not at All; 5 = Extremely) corresponding to how they have been feeling over the past week.
The negative affect subscale contains emotion words such as "Hostile", "Irritable", and "Ashamed'".
A mean score was calculated for use in data analyses, with higher scores indicating greater negative affect.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Emotional Closeness
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Emotional closeness was measured using a modified 10-item version of the Emotional Closeness Questionnaire (ECQ; Flores & Berenbaum, 2012, 2014).
The ECQ presents participants with 10 statements that reflect aspects of emotional closeness (e.g., "my friend gave me emotional support", "I shared my personal thoughts or feelings with my friend").
Respondents rate the degree each of these statements happened over the past week on a scale of 1 (not at all) to 5 (extremely).
Scores from each question are averaged to create an overall score with higher scores indicating higher levels of emotional closeness (Flores & Berenbaum, 2012, 2014).
This questionnaire was modified to ask respondents to specifically consider the close other they chose at the beginning of the study.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Desired Emotional Closeness
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Desired emotional closeness was measured using a modified 10-item version of the Emotional Closeness Questionnaire (ECQ; Flores & Berenbaum, 2012, 2014).
The D-ECQ presents participants with 5 statements that reflect aspects of emotional closeness (e.g., "my friend gives me emotional support", "I share my personal thoughts or feelings with my friend").
Respondents rate the degree to which they would have liked each of these statements to have happened over the past week on a scale of 1 (not at all) to 5 (extremely).
Scores from each question are averaged to create an overall score with higher scores indicating a higher desire for emotional closeness (Flores & Berenbaum, 2012, 2014).
This questionnaire was modified to ask respondents to specifically consider the close other they chose at the beginning of the study.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Worry
Ramy czasowe: Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) was used to measure worry.
The PSWQ asks participants to rate the degree to which 16 statements related to worry are typical or characteristic of them (e.g., "My worries overwhelm me", "Once I start worrying, I can't stop").
Respondents rate each item on a scale from 1 (not at all typical) to 5 (very typical; Meyer et al., 1990).
A mean score was generated for each participant with higher scores indicating higher levels of worry.
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Assessed once at baseline (Day 0) and once at follow-up after the intervention (follow up sent on Day 8).
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily Engagement with the Meditation
Ramy czasowe: Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Engagement was measured after listening to the audio recording.
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After completing the meditation, participants were asked: "On a scale from one to ten, how engaged did you feel with the meditation today?" (higher numbers indicating more engagement in the meditation).
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Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Engagement was measured after listening to the audio recording.
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Daily Negative Affect
Ramy czasowe: Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Negative affect was measured before and after listening to the audio recording.
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Prior to the meditation, participants were asked to rate on a scale from 1-10: "how much negative emotion are you feeling right now?" (higher numbers indicating more negative emotion).
After completing the meditation, this question was repeated.
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Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Negative affect was measured before and after listening to the audio recording.
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Daily Positive Affect
Ramy czasowe: Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Positive affect was measured before and after listening to the audio recording.
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Prior to the meditation, participants were asked to rate on a scale from 1-10 "how much positive emotion are you feeling right now?" (higher numbers indicating more positive emotion).
After completing the meditation, this question was repeated.
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Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Positive affect was measured before and after listening to the audio recording.
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Daily Social Connection
Ramy czasowe: Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Social connection was measured before and after listening to the audio recording.
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Prior to the meditation, participants were asked to rate on a scale from 1-10 "how socially connected to your friend are you feeling right now?" (higher numbers indicating more feelings of social connection).
After completing the meditation, this question was repeated.
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Questionnaires with an embedded meditation were sent each day (Day 1 - Day 7). Social connection was measured before and after listening to the audio recording.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Luis Flores, Ph.D., Queen's University and Rutgers University
Publikacje i pomocne linki
Publikacje ogólne
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
- Clark LA, Watson D. Tripartite model of anxiety and depression: psychometric evidence and taxonomic implications. J Abnorm Psychol. 1991 Aug;100(3):316-36. doi: 10.1037//0021-843x.100.3.316.
- Flores Jr, L. E., & Berenbaum, H. (2014). Desired emotional closeness moderates the prospective relations between levels of perceived emotional closeness and psychological distress. Journal of Social and Clinical Psychology, 33(8), 673-700. https://doi.org/10.1521/jscp.2014.33.8.673
- Flores Jr, L. E., & Berenbaum, H. (2012). Desire for emotional closeness moderates the effectiveness of the social regulation of emotion. Personality and Individual Differences, 53(8), 952-957. https://doi.org/10.1016/j.paid.2012.07.009
- Hayes, A. F. (2018). Introduction to mediation, moderation, and conditional process analysis: A regression-based approach (2nd ed.) Guilford publications.
- Hayes, A. F. (2012). PROCESS: A versatile computational tool for observed variable mediation, moderation, and conditional process modeling [White paper]. Retrieved from http://www.afhayes.com/public/process2012.pdf
- Trautwein FM, Naranjo JR, Schmidt S. Decentering the Self? Reduced Bias in Self- vs. Other-Related Processing in Long-Term Practitioners of Loving-Kindness Meditation. Front Psychol. 2016 Nov 21;7:1785. doi: 10.3389/fpsyg.2016.01785. eCollection 2016.
- Bierhoff, H. W., Grau, I., & Ludwig, A. (1993). Marburger Einstellungsinventar zu Liebesstilen (MEIL). Hogrefe.
- Wheeler, L., & Reis, H. T., (1991). Self-recording of everyday life events: Origins, types, and uses. Journal of Personality, 59, 339-354. doi:10.1111/j.1467-6494.1991.tb00252.x
- Aron, A., Aron, E. N., & Smollan, D. (1992). Inclusion of the other in the self scale and the structure of interpersonal closeness. Journal of Personality and Social Psychology, 63(4), 596-612. https://doi.org/10.1037/0022-3514.63.4.596
- Seppala, E.M., Hutcherson, C.A., Nguyen, D.T., Hutcheson, C. A., & Gross, J. J. (2014). Loving-kindness meditation: A tool to improve healthcare provider compassion, resilience, and patient care. Journal of Compassionate Health Care, 1(1), 1-9. https://doi.org/10.1186/s40639-014-0005-9
- Gachter S, Starmer C, Tufano F. Measuring the Closeness of Relationships: A Comprehensive Evaluation of the 'Inclusion of the Other in the Self' Scale. PLoS One. 2015 Jun 12;10(6):e0129478. doi: 10.1371/journal.pone.0129478. eCollection 2015.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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Plan dla danych uczestnika indywidualnego (IPD)
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- PROTOKÓŁ BADANIA
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Badania kliniczne na Loving-Kindness Meditation
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