NCT00033865

Brief Summary

The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2

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 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2002

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

7.7 years

First QC Date

April 11, 2002

Last Update Submit

April 27, 2015

Conditions

Insomnia

Keywords

InsomniaYogaMeditationBehavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Sleep onset latency

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

Yoga treatment for 8 weeks

Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene

2

NO INTERVENTION

Sleep hygiene instructions only

Interventions

Yoga, Relaxation Exercises, Sleep HygieneBEHAVIORAL

Sleep hygiene and relaxation exercises, with additional yoga

1

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A primary complaint of sleep-onset insomnia for at least 6 months.
  • Reside in the metropolitan Boston area

You may not qualify if:

  • No current other nonpharmacological treatment for insomnia.
  • Ability or willingness to discontinue use of hypnotic medications.
  • No rotating or night shift work, or transcontinental travel throughout the course of the study protocol.
  • No recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital Division of Sleep Medicine

Boston, Massachusetts, 02115, United States

Location

Related Publications (11)

  • Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.

    PMID: 7896994BACKGROUND

  • Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.

    PMID: 8037252BACKGROUND

  • Choliz M. A breathing-retraining procedure in treatment of sleep-onset insomnia: theoretical basis and experimental findings. Percept Mot Skills. 1995 Apr;80(2):507-13. doi: 10.2466/pms.1995.80.2.507.

    PMID: 7675582BACKGROUND

  • Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Panel on Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia. JAMA. 1996 Jul 24-31;276(4):313-8. doi: 10.1001/jama.1996.03540040057033.

    PMID: 8656544BACKGROUND

  • Woolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.

    BACKGROUND

  • Carr-Kaffashan L, Woolfolk RL. Active and placebo effects in treatment of moderate and severe insomnia. J Consult Clin Psychol. 1979 Dec;47(6):1072-80. doi: 10.1037//0022-006x.47.6.1072. No abstract available.

    PMID: 41856BACKGROUND

  • Schoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.

    BACKGROUND

  • Jacobs GD, Rosenberg PA, Friedman R, Matheson J, Peavy GM, Domar AD, Benson H. Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response. A preliminary study. Behav Modif. 1993 Oct;17(4):498-509. doi: 10.1177/01454455930174005.

    PMID: 8216184BACKGROUND

  • Koch, U., Volk, S., Heidenreich, T., and Pflug, B. Yoga treatment in psychophysiological insomnia. Journal of Sleep Research 7(Suppl. 2), 137. 1998.

    BACKGROUND

  • Joshi, KS. Yogic treatment of insomnia: An experimental study. Yoga Mimamsa 1992;30:24-26.

    BACKGROUND

  • Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.

    PMID: 33928908DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sat Bir Singh Khalsa, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 11, 2002

First Posted

April 12, 2002

Study Start

April 1, 2001

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)