Treatment of Insomnia Secondary to Chronic Pain

University of Rochester

Status: Completed

Conditions: Insomnia; Pain

Treatments: Behavioral: CBT for Insomnia (CBT-I); Behavioral: CBT for Pain (CBT-P)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00127790

K23NR010408 (U.S. NIH Grant/Contract)

F32NS049789 (U.S. NIH Grant/Contract)

R21AG023956 (U.S. NIH Grant/Contract)

R21AG023956 ( R24AG031089;Other Identifier)

160743209

Details and patient eligibility

About

Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.

Full description

The investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia & pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity.

The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function.

The investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.

Enrollment: 28 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 35-75
• Chronic non-malignant painful condition of the spine of > 6 months duration
• Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week for > 6 months)
• Insomnia developed after the onset of the painful condition
• Preferred sleep phase between 10:00 p.m. and 8:00 am
• On stable medical regimen for medical and pain conditions (no surgery planned)
• Willingness to discontinue hypnotic medications

Exclusion criteria

• Unstable medical or psychiatric illness
• History of seizures
• Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence
• Symptoms suggestive of sleep disorders other than insomnia
• Polysomnographic data indicating sleep disorders other than insomnia
• Inadequate language comprehension
• Fibromyalgia
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

CBT for Insomnia (CBT-I)

Active Comparator group

Description:

Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.

Treatment:

Behavioral: CBT for Insomnia (CBT-I)

CBT for Pain (CBT-P)

Active Comparator group

Description:

Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.

Treatment:

Behavioral: CBT for Pain (CBT-P)

CBT for Insomnia & Pain (CBT-I/P)

Experimental group

Description:

Combined Cognitive-Behavioral Therapy for Insomnia \& Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.

Treatment:

Behavioral: CBT for Pain (CBT-P)

Behavioral: CBT for Insomnia (CBT-I)

Wait-List Control (WL)

No Intervention group

Description:

Waitlist Control condition (WL) with no contact during the intervention period.