Occupation-based Sleep Program for People With Insomnia
Condition: Insomnia, Primary; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Introduction. Sleep problems are a health issue worldwide. Based on the
      Person-Environment-Occupation-Performance model and the theory of occupational balance, we
      developed an occupation-based sleep program to address several objectives by lifestyle
      intervention: 1) minimize the influence of bodily function on sleep; 2) promote an
      environment conductive to sleep; and 3) restructure daytime activity with a focus on
      occupational balance through psychoeducation and lifestyle coaching.

      Method. This study aims to evaluate the effectiveness of an occupation-based sleep
      intervention on sleep pattern, mood, and occupational balance among community-dwelling adults
      with insomnia when compared with other, more usual, forms of treatment, typically focused on
      education, sleep hygiene, and relaxation. A total of 42 subjects were recruited: 22 for the
      intervention group and 20 for the treatment as usual group.
    

Detailed description: 
      The goal of this study is to investigate the effectiveness of occupation-based sleep program
      for patients with insomnia. It compares the treatment outcomes of sleep pattern, mood, and
      occupational balance between an intervention group (occupation-based sleep program) and a
      treatment-as-usual (TAU) group (sleep hygiene education and relaxation training) upon
      completion of their respective programs and at one-month follow up.

      The occupation-based sleep program includes both group and individual sessions. Each group
      consists of 4 to 6 patients. Each session last for two hours and are held on a weekly basis.
      Group session focus on sharing information and goal setting to facilitate the formation of
      good habits and positively restructure lifestyle. Individual coaching sessions aim to follow
      up on action planning to promote occupational balance.

      This study uses a quasi-experimental design. The participants of the intervention group
      attended the occupation-based sleep program in general outpatient clinic A. Participants in
      the comparison group received TAU in a general outpatient clinic B of another district. The
      three time-points for collection of outcome data are at baseline (T1), after the intervention
      (week 8) (T2), and a one-month post intervention follow up (week 12) (T3). The outcomes will
      be collected by a blinded assessor who is not involved in the delivery or administration of
      the study.

      Participants The inclusion criteria for recruitment of participants are: 1) diagnosis of
      insomnia disorder, 2) referral by general practitioner; 3) aged 18 to 65 years old; 4)
      Insomnia Severity Index score over 14; 5) regularly uses a smart phone, which enable data
      synchronization with the MiBand2 activity wristband; 6) able to complete self-administered
      study questionnaires and 7) able to communicate in Cantonese. The exclusion criteria are: 1)
      diagnosis of severe mental illness; 2) Personal Health Questionnaire 9 (measures depressive
      symptoms), score over 19 and/or anxiety symptoms (General Anxiety Disorder 7 score over 15);
      3) On regular pain medication during the last month, for more than 3 days per week); 4) sleep
      affected by respiratory disease or 5) regular user of alcohol or addictive substances.

      Instruments

      The primary outcome measures of the study are insomnia and sleep quality, and the secondary
      measures are measures of occupational balance, depression, and anxiety.

      Cantonese Version Insomnia Severity Index (C-ISI). The C-ISI is a self-report questionnaire
      that measures the severity of insomnia. A higher score indicate more severe insomnia: Total
      of 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical
      insomnia (moderate severity) 22-28 = Clinical insomnia (severe). Previous studies have
      reported adequate psychometric properties for both the English and Chinese versions.
      Reliability is excellent (α = 0.90-0.91). Sensitivity and specificity at cut-off 10 were
      86.1% and 87.7%, respectively.

      Chinese Version Pittsburgh Sleep Quality Index (C-PSQI). The C-PSQI is a self-report
      questionnaire that measures sleep quality. The questions focus on seven aspects of sleep: 1)
      quality; 2) latency; 3) duration; 4) efficiency; 5) disturbance; 6) use of sleep medication;
      7) daytime dysfunction. Under the seven component scores, each scored 0 (no difficulty) to 3
      (severe difficulty). The component scores are summed to produce a global score (range 0 to
      21). Higher scores indicate worse sleep quality.The psychometric properties of the PSQI have
      been well documented. The Chinese translated version demonstrated good internal consistency
      (α = 0.82-0.83), and acceptable test-retest reliability over a 14- to 21-day intervals (r =
      0.77) for patient with insomnia. It demonstrated good convergent validity, with significant
      correlations with sleep quality-visual analogues scale and sleep diary. It could
      differentiate people with and without insomnia, sensitive and specificity of 98% and 55%
      respectively.

      Activity Wristband. The Mi Band 2 is a commercially available activity wristband commonly
      used for measuring activity level and sleep pattern. A recent research stated that three
      types of CAM (including Mi Band 2, the device selected for use in the present study) were
      good at detecting the most basic parameters, actual time spent in bed. MiBand2 that was
      selected for this study monitors a user's sleep and physical activity neutrally. It provides
      objective data on sleep duration on a weekly basis, including information about sleep
      duration, number of nighttime awakenings, and typical sleeping habits.

      Occupational Balance Questionnaire (OB-Quest). The OB-Quest is a self-completed questionnaire
      developed to measure occupational balance in daily life, It focuses on satisfaction with the
      amount and variation of occupation. It consists of 13 items measured on six-step ordinal
      scales, and a lower score indicates a better balance. The internal consistency of the
      OB-Quest is 0.9, and test-retest reliability is also 0.9. A translation and validation study
      of the Chinese OB-Quest was completed. The study results showed that the Chinese version of
      OB-Quest can be readily used for research with Chinese persons.

      Personal Health Questionnaire 9 (PHQ9). PHQ9 is a self-administered version of part of the
      Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common
      mental disorders. It is the depression module of the PHQ, which scores each of the nine
      Diagnostic & Statistical Manual version 4 (DSM-IV) criteria as "0" (not at all) to "3"
      (nearly every day). It has been validated for use in primary care, for monitoring the
      severity of depression and response to treatment. A higher total score indicate more severe
      depression. It is commonly used for screening depression. PHQ9 is a reliable tool with good
      reliability and validity. The psychometric properties for patients with depression in a
      Chinese primary care population were found to be acceptable to good.

      d General Anxiety Disorder-7 (GAD 7). This questionnaire is part of the PRIME-MD diagnostic
      instrument for common mental disorders. The Generalised Anxiety Disorder-7 (GAD-7) is a
      seven-item instrument that is used to measure or assess the severity of generalised anxiety
      disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms
      over the past two weeks.

      The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response
      categories of 'not at all', 'several days', 'more than half the days', and ' nearly'. The Cut
      points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe
      levels of anxiety on the GAD-7. Previous studies have shown GAD7 to have a high degree of
      reliability and validity, as well as high internal consistency.

      Statistical Analysis The Statistical Package for the Social Sciences (SPSS) (Version 25) is
      used for data analysis. Descriptive statistics were used to describe the demographic
      characteristics and outcomes. The baselines of the two groups were compared by t test and
      Chi-square. Repeated measure ANOVA (General Linear Model) was used to analyze the
      effectiveness of the program. Pairwise difference was tested on the outcomes between
      different time points (baseline vs. post treatment, post treatment vs. one-month follow-up),
      between the two groups.
    

Intervention name(s): Occupation-based sleep intervention program; Insomnia Education Program at Integrated Mental Health Clinic (IMHC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A program composed of four occupation-based interactive workshops on sleep, insomnia, lifestyle, and change strategies, plus two individual coaching sessions on lifestyle and sleep hygiene.; A program composed of four educational sessions on sleep and insomnia, plus relaxation training, plus two individual review sessions on sleep hygiene with participant.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Occupational Therapy; Sleep; Evaluation