Treatments for Insomnia: Mediators, Moderators and Quality of Life

Palo Alto Veterans Institute for Research

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Sleep Restriction; Behavioral: Combined Therapy; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02117388

1R01MH101468-01 (U.S. NIH Grant/Contract)

27264

Details and patient eligibility

About

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).

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 3 patient groups

Cognitive Behavioral Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Sleep Restriction

Experimental group

Description:

Sleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly.

Treatment:

Behavioral: Sleep Restriction

Combined Therapy Treatment for Insomnia

Experimental group

Description:

Combined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other.

Treatment:

Behavioral: Combined Therapy