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

NCT03713996 | Completed DMC

• 1 other identifier: STUDY00142985
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Insomnia

Keywords

Cognitive Behavioral Therapy for Insomnia; Self-Care; Fatigue; Diabetes; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index

  The Insomnia Severity Index is a self-report measure designed to evaluate the nature, severity, and impact of insomnia.Seven-items assess severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress due to the sleep difficulties.This is self-reported seven items on a five-point Likert scale from zero (not at all satisfied) to four (very much satisfied). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.

  Insomnia severity will be assessed at the baseline and 8 weeks.

Secondary Outcomes (14)

• Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph

  The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.

• Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph

  The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.

• Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph

  The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.

• Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph

  The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.

• Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary

  The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.

Study Arms (2)

CBT-I intervention

EXPERIMENTAL

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

Behavioral: Cognitive behavioral therapy for insomnia

Diabetes Education

ACTIVE COMPARATOR

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.

Other: Health Education

Interventions

Cognitive behavioral therapy for insomnia 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).

CBT-I intervention

Health Education 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).

Diabetes Education

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• 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.

  PMID: 32891140 DERIVED

• 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.

  PMID: 31855189 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue; Diabetes Mellitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

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: Professor and Chair, Department of Physical Therapy and Rehabilitation Science

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 22, 2018
• Study Start: January 16, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The protocol will be submitted to an open access journal and will be available to everyone.

Locations

US (1)