The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
Condition: Type2 Diabetes; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Cognitive behavioral therapy for insomnia; Health Education
Intervention type(s): Behavioral; Other
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy for Insomnia; Self-Care; Fatigue; Diabetes; Glycemic Control