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Well-Being, PsychologicalNCT06483568

Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention

A study testing Pathways to Happiness Intervention and Personal Organization Activities in people with Well-Being, Psychological, run by Rutgers, The State University of New Jersey.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to learn if engaging in a multi-activity positive psychology intervention increases emotional well-being The main aims of this project are to: 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Well-Being, Psychological
What is being tested?
Pathways to Happiness Intervention and Personal Organization Activities
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
No sites listed yet
Study dates
15 Jul 2024to 1 Jul 2025
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

  • Fluent or native English speaker capable of completing survey questionnaires in English

Who cannot join

  • Major depressive disorder (PHQ-9 > or = 15)

About this study

The goal of this clinical trial is to learn if engaging in a multi-activity positive psychology intervention increases emotional well-being

The main aims of this project are to:

Read more
  1. Test the efficacy of a multi-activity positive psychology intervention for increasing emotional well-being in a racial-ethnically and socioeconomically diverse sample.
  2. Identify physical and social behavioral mechanisms driving positive psychology intervention effects on emotional well-being change and the durability of these effects over time.
  3. Examine physical health outcomes stemming from emotional well-being gains.

Participants will:

Visit the laboratory three times to complete survey measures and physical assessments.

Complete brief survey items three times a day for 10 weeks of the study period. Engage with assigned activities weekly for four weeks of the study period.

Read the detailed description

Participation will span 20 weeks around a four-week treatment phase. Assessments will involve three lab visits and experience sampling method surveys completed on participants' smart phones in response to short message service (SMS) message alerts.

Lab Visit 1 (Baseline): Participants will begin participation with an in-person lab visit held in small groups. This visit will begin with a guided informed consent procedure. Participants will complete baseline self-report measures and physiological assessments and receive procedure instructions.

Pre-Intervention Monitoring (weeks 1 \& 2): For two weeks, participants will compete three very brief experience sampling surveys per day.

Random Assignment, Treatment and Monitoring (weeks 3,4,5,\& 6): Participants will be randomly assigned to the online four-week Pathways to Happiness treatment condition or a matched activity control condition. All participants will complete the four weeks of activities (either Pathways to Happiness Positive Psychology Intervention (PPI) or control activities) on the Pathways to Happiness platform. They will complete weekly check-in items on the Pathways to Happiness platform to assess their compliance with the activity instructions and their experiences with the activities. Participants in both conditions will continue completing experience sampling surveys during this time.

Lab Visit 2 (Post-Test), after week 6: The second lab visit will occur after week six, following the treatment phase. It will involve identical questionnaires and physiological screenings as in the baseline visit.

Post-Intervention Monitoring (weeks 7\&8): After the treatment phase, two weeks of post-intervention experience sampling survey monitoring will begin.

Waiting Period: Participants will not engage in any formal study activities from weeks 9 to 19.

Follow-Up Monitoring (weeks 19-20): Follow-up experience sampling monitoring will commence for the final two weeks of the study, 10 weeks after the previous monitoring period.

Lab Visit 3 (Follow-Up), after week 20: The final lab visit, identical to the others, will occur after week 20 and will conclude with an exit interview regarding participants' experiences in the study and with each PPI activity.

Being tested
Pathways to Happiness Intervention, Personal Organization Activities
Keywords
Emotional Well-Being, Happiness, Gratitude, Kindness, Self-Compassion, Capitalization
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pathways to Happiness InterventionBehavioural

    Four weeks of activities including a gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.

  • Personal Organization ActivitiesBehavioural

    Four weeks of activities including a completed tasks journal, weekly "task burst," productivity letter, and talking to others about task activities.

Study groups in NCT06483568
Study groupRoleWhat they receive
Positive Psychology Intervention ActivitiesExperimentalFour week intervention with four weekly activities including gratitude journal, random acts of kindness, self-compassionate letter, and capitalizing on positive events activities.
Receives: Behavioral: Pathways to Happiness Intervention
Personal Organization ActivitiesSham comparatorControl participants will complete procedure-matched activities related to personal organization, including writing in a completed tasks journal, completing a weekly task burst, productivity letter, and talking to others about tasks activities.
Receives: Behavioral: Personal Organization Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life Satisfaction

    Satisfaction with Life Scale, 1-7 scale, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  2. Positive Affect

    Scale of Positive and Negative Affect, 1-5 scale, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  3. Negative Affect

    Scale of Positive and Negative Affect, 1-5 scale, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  4. Meaning in Life

    Meaning in Life Questionnaire, 1-7 scale, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  5. Optimism

    Life Orientation Test-Revised, 1-5 scale, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  6. Perceived General Health

    Medical Outcomes Study (MOS) Short Form Health Survey (SF-36), General Health Perceptions Subscale, 1-5, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  7. Blood Pressure

    Systolic and Diastolic Blood Pressure In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  8. Heart Rate

    In-lab measurement with OMRON 10 Series Wireless Upper Arm Blood Pressure Monitor

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  9. Peak Expiratory Flow Rate

    In-lab measurement with EasyOne Air Spirometer

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  10. Grip Strength

    In-lab measurement with Jamar Plus+ Digital Hand Dynamometer

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  11. Momentary Mood

    Rate your current mood. 1 (very bad) to 7 (very good), higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  12. Momentary Meaning in Life

    Daily Meaning Scale, 1-7, higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

Secondary outcomes (42)

  1. Amusement

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  2. Awe

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  3. Compassion

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  4. Contentment

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  5. Joy

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  6. Love

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  7. Pride

    Dispositional Positive Emotions Scale, 1-7, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  8. Hope

    State Hope Scale, 1-8, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  9. Depression

    Patient Health Questionnaire-9, 0-27, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  10. Anxiety

    State-Trait Anxiety Inventory, 1-4, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  11. Perceived Stress

    Perceived Stress Scale, 0-4, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  12. Loneliness

    UCLA Loneliness Scale, 1-4, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  13. Social Connectedness

    Comprehensive Inventory of Thriving, 1-5, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  14. Social Support

    Perceived Social Support Scale, 1-5, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  15. Sleep Quality

    Pittsburgh Sleep Quality Index, 0-21, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  16. Cigarette Use

    cigarette smoking days/month x cigarettes per average smoking day, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  17. Tobacco Use (non-cigarette products)

    tobacco use days/month x average uses per day of using, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  18. Alcohol Use

    days in last month drinking x average number of drinks/drinking day, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  19. Vigorous Activity Level

    International Physical Activity Questionnaire, days/week x minutes/day, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  20. Moderate Activity Level

    International Physical Activity Questionnaire, days/week x minutes/day, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  21. Walking

    International Physical Activity Questionnaire, days/week x minutes/day, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  22. Physical Functioning

    MOS Short Form Health Survey (SF-36), Physical Functioning Subscale, 1-3, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  23. Role Functioning--Physical

    MOS Short Form Health Survey (SF-36), Physical Role Functioning Subscale, 0-4, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  24. Role Functioning--Emotional

    MOS Short Form Health Survey (SF-36), Emotional Role Functioning Subscale, 0-3, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  25. Social Functioning

    MOS Short Form Health Survey (SF-36), Social Functioning Subscale, 0-5, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  26. Sitting

    International Physical Activity Questionnaire, hours/weekday, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  27. Bodily Pain

    MOS Short Form Health Survey (SF-36), Pain Subscale, 2-11, lower scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  28. General Mental Health

    MOS Short Form Health Survey (SF-36), General Mental Health Subscale, 1-6, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  29. Vitality

    MOS Short Form Health Survey (SF-36), Vitality Subscale, 1-6, higher scores better

    Measured: baseline, immediate post-treatment, 14-week post-treatment follow-up

  30. Momentary physical activity

    Physical activity behaviors checklist, 0-3, higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  31. Momentary tobacco use

    Have you used a tobacco product in the previous 4 hours? 0 (no)/1(yes), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  32. Momentary alcohol use

    Have you consumed alcohol in the previous 4 hours? 0 (no)/1(yes), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  33. Momentary eating

    Have you eaten [fruit or vegetable/sugary dessert, snack, or beverage] in the previous 4 hours? 0-2, higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  34. Momentary connective Behaviors

    Connective behaviors checklist, 0-5, higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  35. Momentary Stress

    How stressed do you feel right now? 1(not at all) to 7 (very much), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  36. Momentary Depression

    How depressed do you feel right now? 1(not at all) to 7 (very much), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  37. Momentary Anxiety

    How anxious do you feel right now? 1(not at all) to 7 (very much), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  38. Momentary Loneliness

    How lonely do you feel right now? 1(not at all) to 7 (very much), lower scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  39. Momentary Perceived General Health

    How do you feel in terms of your physical health right now? 1 (poor) to 5 (excellent), higher scores better

    Measured: 3x daily; weeks 1-8, 19, 20

  40. Sleep Quality

    How would you rate the quality of your sleep last night? 1 (very bad) to 4 (very good), higher scores better

    Measured: 1x daily; weeks 1-8, 19, 20

  41. Sleep Duration

    Wake up time - (lights out time + time to fall asleep), higher scores better

    Measured: 1x daily; weeks 1-8, 19, 20

  42. Common Symptoms Checklist

    1-5, lower scores better

    Measured: 1x daily; weeks 1-8, 19, 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start15 Jul 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to complete positive psychology intervention activities or procedure-matched activities related to personal organization.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483568
Sponsor's protocol ID
Pro2023002402
Status last verified
Jun 2024
First submitted
26 Apr 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data collected during the trial, after deidentification, and the study protocol materials will be shared on the Open Science Framework.

Questions about this trial

What is this clinical trial studying?

A study testing Pathways to Happiness Intervention and Personal Organization Activities in people with Well-Being, Psychological, run by Rutgers, The State University of New Jersey.

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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Life Satisfaction (time frame: baseline, immediate post-treatment, 14-week post-treatment follow-up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06483568.

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 3 Jul 2024.

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