Treatments for Insomnia: Mediators, Moderators and Quality of Life

Insomnia Clinical Trial

Official title:

Treatments for Insomnia: Mediators, Moderators and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117388
• Other study ID #: 27264
• Secondary ID: 1R01MH101468-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: August 23, 2019

Study information

• Verified date: September 2019
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).

Description:

As many as one in three older adults may experience insomnia. Older adults are the most frequent users of hypnotic medications. Although safer, use of even the latest "sleeping pills" can lead to cognitive impairment and risk of falls. Thus, it is not surprising that non-pharmacological treatments for insomnia have been pursued as alternatives to medications, with some suggesting they should be the "first line of therapy". We propose a randomized clinical trial to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia (CBT-I): sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the proposed mechanisms of action of CT versus SR substantially differ, their combination may have additive effects. Even though the mechanisms of action of SR and CT may differ, no data exists to document that the addition of one to the other provides more overall clinical benefit than either intervention alone. Finally, to better understand "how" and "in whom" SR and CT work, we plan to formally evaluate selected mediators and moderators of the clinical effect including physiological measures of anxiety and arousal. Three treatments (SR, CT, and SR+CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after 6 weeks of treatment, and at the end of a 6-month follow-up. These efforts follow the National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative interventions and designs for intervention studies, in this case, to promote a new intervention trial that focuses on the mediators and moderators of treatment response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Males or females of any racial or ethnic group, aged 60 years old or older

• Independent living (not in nursing home, etc.)

• English-speaking

• Subjective complaint of insomnia associated with daytime impairment or distress

• DSM 5 (Diagnostic and Statistical Manual V) diagnosis of insomnia

• Score >10 on the Insomnia Severity Indexa

• Must live within 40 miles of Stanford University

Exclusion Criteria:

• Montreal Cognitive Assessment Scale <20

• Apnea-hypopnea index >10 or Periodic limb movement associated arousals > 5 per hour

• Use of medication specifically prescribed for sleep and unwilling or unable to discontinue > one week prior to baseline data collection.

• Acute or unstable chronic illness: including but not limited to insulin dependent diabetes (adult onset diabetes, controlled with oral medications or diet is acceptable); uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; conditions associated with chronic pain such as fibromyalgia; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months.

• Use of CNS (central nervous system) active medications that would significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (> 4 weeks).

• Excessive caffeine consumption (= three cups per day), excessive alcohol consumption (> 14 drinks per week or > 4 drinks per occasion), or illicit substances (by self-report).

• Major psychiatric diagnosis on Axis I of DSM-IV as tested by the Mini International Neuropsychiatric Interview (Version 5.0).

• Lives more than 40 miles from Stanford University

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep Restriction
Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.
• Cognitive Behavioral Therapy
Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep.
• Combined Therapy
Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	National Institute of Mental Health (NIMH), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	Subject's subjective evaluation of their sleep.	Screening, End of 6-week treatment, 6-month follow-up
Secondary	Cognitive Arousal	Score on Penn State Worry Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep Scale.; Both measures have been found to be successful in measuring mediators and moderators of treatment response.	Screening, end of 6-week treatment, 6-month followup
Secondary	Chronic Stress	We are using two of the most widely utilized psychometric indices of past, present and chronic stress exposure: 1) the Trauma History Questionnaire, and 2) the Life Stressor Checklist revised, a clinical interview for lifetime exposure to stressful life events.	Screening, end of 6-week treatment, 6-month followup