The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes

NCT ID: NCT03713996

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2019-06-01

Brief Summary

Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue and inconstant sleep schedule, which negatively influence quality of life. However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown. Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.

Detailed Description

Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue, which negatively influences quality of life. However, the additive effect of insomnia symptoms on diabetes outcomes and health status in people with T2D is unknown. Therefore, it is imperative to investigate the contributing factor that affects DSCB and health outcomes to help individuals with diabetes reach their goals.

Assessing sleep variability is very important clinically and practically for people with insomnia. People with insomnia have higher night to night sleep variability compared to healthy individuals. Compared to other populations, people with T2D might suffer from sleep disturbances due to diabetes symptoms such as frequency nocturnal urination, hyperglycemia, insulin resistance, obesity, pain and fatigue, which might influence the sleep variability. The nature of insomnia is not representable by using mean values, as the reduction in the sleep variability values is a predictor for insomnia and depression recovery. Therefore, understanding the sleep variability in people with T2D with or without insomnia symptoms may add complementary evidence for future studies.

An effective treatment for people with insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is superior to sleep medications in terms of cost and long term benefits. Although there is currently limited evidence about the effect of CBT-I on people with T2D, CBT-I is a potentially effective intervention given insomnia's relationship with glucose metabolism. The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.

Conditions

Type2 Diabetes; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-I intervention

The intervention includes several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

CBT-I is designed to change sleep habits as well as direct misconceptions about sleep and insomnia. Participants will receive several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. The intervention will be provided in 6-session (one session/week).

Diabetes Education

Sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity will be delivered for the Health Education group. During all sessions, subjects will be encouraged to engage in the discussion through open questions about their experience in diabetes, lifestyle, and understanding about provided materials.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: OTHER

Participants in this arm will receive education in sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity. The education will be provided in 6-session (1 session/week).

Interventions

Cognitive behavioral therapy for insomnia

CBT-I is designed to change sleep habits as well as direct misconceptions about sleep and insomnia. Participants will receive several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. The intervention will be provided in 6-session (one session/week).

Intervention Type: BEHAVIORAL

Health Education

Participants in this arm will receive education in sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity. The education will be provided in 6-session (1 session/week).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 40 to 75 years
• Self-reported diagnosis of type 2 diabetes
• Insomnia Severity Index >10 and self-reported symptoms of insomnia at least 3 nights/week for the past 3 months for insomnia and type 2 diabetes group
• Insomnia Severity Index ≤10 for type 2 diabetes only group
• Able to attend 6 sessions
• Able to understand and follow verbal commands in English
• Able to travel to our lab

Exclusion Criteria

• Self-reported neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, Traumatic Brain Injury, Stroke, Multiple Sclerosis)
• Stop-Bang > 4 indicating severe risk of sleep apnea
• Failure to pass Restless Leg Syndrome Diagnostic Index
• Severe pain ≥ 7 out of 10 on Brief Pain Inventory
• Severe symptom level of depression scores ≥ 21 on Beck Depression Inventory
• Severe symptom level of anxiety scores ≥ 15 on Generalized Anxiety Scale-7
• Pregnant women
• Self-reported following medical issues: Chronic Fatigue Syndrome, Fibromyalgia, and Rheumatic Diseases
• Speech deficits or significant auditory impairment
• Night-shift work
• Self-reported Bipolar and Seizure Disorders
• Heavy alcohol drinker (≥15 drinks per week for men and ≥ 8 drinks per week for women)
• Dialysis/blindness/trans-femoral amputation

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patricia Kluding, PhD

Professor and Chair, Department of Physical Therapy and Rehabilitation Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

Alshehri MM, Alothman SA, Alenazi AM, Rucker JL, Phadnis MA, Miles JM, Siengsukon CF, Kluding PM. The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes. BMC Endocr Disord. 2020 Sep 5;20(1):136. doi: 10.1186/s12902-020-00612-6.

Reference Type: DERIVED

PMID: 32891140 (View on PubMed)

Alshehri MM, Alenazi AM, Hoover JC, Alothman SA, Phadnis MA, Rucker JL, Befort CA, Miles JM, Kluding PM, Siengsukon CF. Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 19;8(12):e14647. doi: 10.2196/14647.

Reference Type: DERIVED

PMID: 31855189 (View on PubMed)

Other Identifiers

STUDY00142985

Identifier Type: -

Identifier Source: org_study_id