NCT03257527

Brief Summary

The study is designed to compare the efficacy of two programs intended to improve happiness and well-being among healthy, community adults between the ages of 25 and 75 years. Participants will complete either an in-person program (ENHANCE) or a mindfulness-based stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include 12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR self-help guide will teach ways to replace stress-promoting habits. Participants will be asked to complete a series of measures at three points of the study: at the start of the study, the end of the study, and 3-months following the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

August 8, 2017

Last Update Submit

June 10, 2020

Conditions

Keywords

Well-beingComparative Clinical TrialPositive Psychology InterventionMindfulness Based Stress Reduction (MBSR)Group TherapyHappinessBibliotherapy

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline Satisfaction With Life

    Satisfaction With Life Scale

    Baseline, 3, 6 months

  • Change from Baseline in Positive Affect

    Scale of Positive and Negative Experience: SPANE

    Baseline, 3, 6 months

  • Change from Baseline in Negative Affect

    Scale of Positive and Negative Experience: SPANE

    Baseline, 3, 6 months

  • Change from Baseline in Meaning in Life

    Meaning in Life Questionnaire

    Baseline, 3, 6 months

  • Change from Baseline in Thriving

    Comprehensive Inventory of Thriving

    Baseline, 3, 6 months

Secondary Outcomes (6)

  • Change from Baseline in Physical Activity

    Baseline, 3, 6 months

  • Change from Baseline in Perceived Social Support

    Baseline, 3, 6 months

  • Change from Baseline in Relationship Satisfaction

    Baseline, 3, 6 months

  • Change from Baseline to attention, concentration, reaction time, memory, processing speed, executive functioning and decision-making

    Baseline, 3, 6 months

  • Change from Baseline in Implicit Theories of Well-Being

    Baseline, 3, 6 months

  • +1 more secondary outcomes

Other Outcomes (16)

  • Change from Baseline Positive and Negative Memories Generated by Participants

    Baseline, 3, 6 months

  • Change from Baseline Peer Reports of Positive Behaviors

    Baseline, 3, 6 months

  • Change from Baseline Peer Reports of Satisfaction With Life

    Baseline, 3, 6 months

  • +13 more other outcomes

Study Arms (2)

ENHANCE group

EXPERIMENTAL

The ENHANCE group is comprised of 12 weekly session to be completed in-person and delivered by trained group facilitators.

Behavioral: ENHANCE group

MBSR group

ACTIVE COMPARATOR

The MBSR group will complete a self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook" over a 12 week period.

Behavioral: MBSR group

Interventions

ENHANCE groupBEHAVIORAL

The ENHANCE program includes an initial 3-month treatment of 12 weekly sessions (including an introductory session, a final session, and 10 content sessions) followed by a 3-month maintenance phase intervention with bi-weekly sessions. Over the course of the program, participants will learn about 10 evidenced-based principles of happiness and how these principles can be applied effectively in their lives. At the final session, participants will receive feedback outlining the happiness principles and activities that fit them best, and will then be asked to work on creating a plan for integrating those principles into their daily lives.

ENHANCE group
MBSR groupBEHAVIORAL

The MBSR program is based on the self-help workbook entitled, "A Mindfulness-Based Stress Reduction Workbook". This workbook is authored by Drs. Bob Stahl and Elisha Goldstein - who are both certified MBSR trainers. The workbook is written to help everyday people learn how to replace stress-promoting habits with mindfully-based ones to improve overall well-being. The workbook begins by providing a thorough introduction to the basic tenets of mindfulness, and improving well-being through the use of mindfulness-based skills. The workbook outlines, in detail, several skills-based exercises for practicing mindfulness across different aspects of a person's life. The MBSR group will be provided with a recommended weekly schedule for the initial 3-month treatment and a list of additional resources to be completed over the 3-month maintenance phase.

MBSR group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants in the study will include males and females between the ages of 25 and 75 years. Participants of all racial and ethnic backgrounds will be eligible to participate. Participants of all religious and spiritual orientations will be eligible to participate.

You may not qualify if:

  • Participants will be screened for major psychological disorders, such as anxiety and depression using the Patient Health Questionnaire-9 (PHQ-9. Participants who are screened with a major mental illness (such as severe depression as determined by a cut-off score of 15 or greater on the PHQ-9) will be advised that this study is not designed as a treatment for mental illness (including severe depression), and will be given a list of the appropriate mental health services offered in their community (e.g., Kelowna Mental Health and Substance Use Services).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V1V7, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director of Clinical Training

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 22, 2017

Study Start

April 10, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations