Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Insomnia

Treatments: Behavioral: mind body treatment; Behavioral: desensitization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00303342

R01AT002490 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

Full description

There is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. Accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. Previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. The aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. Objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. Continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. We anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. We also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. Given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. If achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary insomnia for 6 months
• average total wake time >60 minutes and sleep efficiency <80%
• at least 1 daytime complaint due to insomnia
• adequate opportunity and circumstance for sleep

Exclusion criteria

• current psychiatric condition
• medical condition that interferes with sleep
• pregnancy
• rotating shift work, night work or transcontinental travel during study
• anticipated major life stressor over the course of the study
• use of hypnotic or psychoactive medications
• no idiopathic or sleep state misperception insomnia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

mind body treatment

Experimental group

Description:

regulation of attention, respiration and posture

Treatment:

Behavioral: mind body treatment

desensitization

Active Comparator group

Description:

mentation on insomnia behaviors and cognitive activity

Treatment:

Behavioral: desensitization