NCT03489148

Brief Summary

Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and positive emotions have profound, positive impacts on health and reduce perceived stress. The current study is an exploration of Tamarkoz®, a Sufi practice that is a method to concentrate, as a pathway by which spirituality and positive emotions effect perceived stress. Tamarkoz® incorporates physical, emotional, and spiritual aspects of an individual. In its current form, it includes Movazaneh® which is movement balancing developed by the Sufi Master, Professor Nader Angha. Movazaneh® movements direct concentration of the mind to a state of collectiveness and activates electromagnetic centers in the body, which are said to develop spirituality in an individual. A national survey of college students indicated that over 80% have interest in spiritual development. Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks. Participants, diverse university students, had no prior exposure to Tamarkoz®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

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

August 24, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

March 4, 2018

Last Update Submit

April 3, 2018

Conditions

Keywords

StressRelaxationHealth promotion

Outcome Measures

Primary Outcomes (1)

  • Perceived stress scale

    The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress.

    Change between baseline and 18 weeks

Secondary Outcomes (1)

  • Salivary Immunoglobulin A (SIgA) in Saliva

    Change between baseline and 18 weeks

Study Arms (3)

Tamarkoz®

EXPERIMENTAL

A Sufi method to focus, called Tamarkoz®. Participants had met in class twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met with a Tamarkoz® instructor to learn meditation techniques.

Behavioral: Tamarkoz®

Stress Management Resources

ACTIVE COMPARATOR

The self-care stress management group used the campus resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, and online reading materials for stress management as needed for themselves.

Behavioral: Stress management resources

Waitlist

NO INTERVENTION

The waitlist control group did not receive Tamarkoz® and did not use the stress management resources on campus for the duration of the study.

Interventions

Tamarkoz®BEHAVIORAL

Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization.

Tamarkoz®

Use of the campus health center's stress management resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, pet-an-animal a week, and online reading material about self-care for stress management.

Stress Management Resources

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University of California, Berkeley students between the ages of 18-30 years

You may not qualify if:

  • work third shifts
  • diabetes
  • post-traumatic stress disorder
  • liver disease
  • autoimmune diseases
  • severe depression that resists treatment or impacts ability to function
  • schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (49)

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Related Links

Study Officials

  • Nasim Bahadorani, DrPH

    Loma Linda University

    PRINCIPAL INVESTIGATOR
  • Jerry W Lee, PhD

    Loma Linda University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The Tamarkoz® class instructor was not informed about which of her students from the class was participating in the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2018

First Posted

April 5, 2018

Study Start

August 24, 2015

Primary Completion

February 4, 2016

Study Completion

February 4, 2016

Last Updated

April 5, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 6 months and ending 5 years following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations