A Behavioral Therapy for Insomnia Co-existing With COPD

NCT01973647 | Completed DMC

• 1 other identifier: 2013-0626
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times \< 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.

Conditions

Insomnia; COPD; Chronic Obstructive Pulmonary Disease; Fatigue

Keywords

insomnia; cognitive behavioral therapy; COPD; fatigue

Outcome Measures

Primary Outcomes (1)

• Insomnia

  Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.

  Up to 18 weeks

Secondary Outcomes (9)

• Fatigue

  Up to 18 weeks

• Beliefs about sleep

  Up to 18 weeks

• Sleep habits

  Up to 18 weeks

• Self-efficacy for sleep

  Up to 18 weeks

• Self-efficacy for COPD management

  Up to 18 weeks

Study Arms (4)

Cognitive Behavioral Therapy (CBT-I)

EXPERIMENTAL

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

CBT-I + COPD-ED

EXPERIMENTAL

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education

Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: COPD Education

COPD Education (COPD-ED)

EXPERIMENTAL

Six weekly sessions of COPD education

Behavioral: COPD Education

Attention Control (AC)

PLACEBO COMPARATOR

Six weekly sessions of non-sleep, non-COPD health education

Behavioral: Attention Control

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Six weekly sessions of cognitive behavioral therapy for insomnia

CBT-I + COPD-ED; Cognitive Behavioral Therapy (CBT-I)

COPD Education BEHAVIORAL

Six weekly sessions of COPD education

CBT-I + COPD-ED; COPD Education (COPD-ED)

Attention Control BEHAVIORAL

Six weekly sessions of non-sleep, non-COPD health education

Attention Control (AC)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to very severe COPD.
• age ≥ 45 years of age with no other major healthproblems.
• clinically stable at the time of enrollment into the study.
• insomnia.

You may not qualify if:

• evidence of restrictive lung disease or asthma.
• pulse oximetry reading of \< 90% at rest or \< 85% at night for \> 5 min.
• evidence of a major sleep disorder other than insomnia.
• hypnotic use.
• acute respiratory infection within the previous 2 months.
• presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
• a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \> 11.
• currently participating in pulmonary rehabilitation.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• Kapella MC, Herdegen JJ, Perlis ML, Shaver JL, Larson JL, Law JA, Carley DW. Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Int J Chron Obstruct Pulmon Dis. 2011;6:625-35. doi: 10.2147/COPD.S24858. Epub 2011 Nov 24.

  PMID: 22162648 BACKGROUND

• Jun J, Park C, Fritschi C, Balserak B, Martyn-Nemeth P, Kuna S, Kapella M. Behavioral interventions and symptom cluster change in adults with chronic obstructive pulmonary disease and insomnia. Heart Lung. 2024 Mar-Apr;64:6-13. doi: 10.1016/j.hrtlng.2023.11.001. Epub 2023 Nov 15.

  PMID: 37976563 DERIVED

• Kapella M, Steffen A, Prasad B, Laghi F, Vispute S, Kemner G, Teixeira C, Peters T, Jun J, Law J, Carley D. Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components. J Clin Sleep Med. 2022 Dec 1;18(12):2763-2774. doi: 10.5664/jcsm.10210.

  PMID: 35946416 DERIVED

• Kapella MC, Herdegen JJ, Laghi F, Steffen AD, Carley DW. Efficacy and mechanisms of behavioral therapy components for insomnia coexisting with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2016 May 23;17(1):258. doi: 10.1186/s13063-016-1334-0.

  PMID: 27215949 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pulmonary Disease, Chronic Obstructive; Fatigue

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mary C Kapella, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 31, 2013
• Study Start: June 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)