Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Incidence of chronic insomnia |
the diagnostic criteria for chronic insomnia disorder according to DSM-5 |
3 months |
|
Secondary |
Changes in Ford Insomnia Response to Stress Test (FIRST) |
FIRST, a measure to identify individuals predisposed to sleep disturbance and the subsequent development of chronic insomnia. This nine-item self-report instrument assesses the potential likelihood that an individual will experience sleep disturbance following various stressful events/situations. FIRST scores range from 9 to 36. |
baseline and 3 months |
|
Secondary |
Changes in Short Form 12-Item Health Survey version 2(SF-12v2) |
The SF-12v2 is a 12-item self-report questionnaire used to assess generic health outcomes from the patient's perspective.The SF-12v2 addresses the 8 domains viz. Physical functioning (PF), Role - physical (RP),Bodily pain (BP),General health perceptions (GH),Vitality (V),Social functioning (SF),Role - emotional (RE) and Mental health (MH) . The 2 scores that will be obtained from this assessment are composite scores representing physical health and mental health composite summaries, PCS and MCS respectively. |
baseline and 3 months |
|
Secondary |
Changes in Sleep Hygiene and Practices Scale(SHPS) |
Subjects' general sleep hygiene and practices are measured with Sleep Hygiene and Practices Scale.The SHPS is a 30-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a six-point scale ranging from 1 to 6 . Total scores range from 30 to 180. SHPS has shown adequate reliability and validity . |
baseline and 3 months |
|
Secondary |
Changes in Pre-Sleep Arousal Scale(PSAS) |
Participant's problems during initiation of sleep is assessed with Pre-Sleep Arousal Scale.The Pre-Sleep Arousal Scale (PSAS) is a brief self-administered measure in which participants rate the intensity of experienced arousal. Internal consistency for somatic (8 items) and cognitive (8 items) subscales are satisfactory (a = 0.81 and a = 0.76) respectively. |
baseline and 3 months |
|
Secondary |
Changes in Epworth Sleepiness Scale(ESS) |
Subjective measure of a patient's sleepiness is measured with Epworth Sleepiness Scale.The Epworth Sleepiness Scale is a self-report 8-item questionnaire producing scores from 0 to 24. Scores greater than 10 suggest significant daytime sleepiness. The Epworth Sleepiness Scale has good psychometric properties , correlates with objective measures of sleepiness , and has been shown to differentiate between individuals with and without sleep disorders and those who are and are not sleep deprived. |
baseline and 3 months |
|
Secondary |
Changes in Hospital Anxiety and Depression Scale (HADS) |
The HADS is a self-report questionnaire to determine the levels of anxiety and depression that a participant is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83. |
baseline, week 2, and 3 months |
|
Secondary |
Treatment Component Adherence Scale (TCAS) |
A self-reported questionnaire will be administered posttreatment to assess adherence to CBTI guidelines and the perceived helpfulness of treatment guidelines. Adherence to each therapeutic element will be rated on a 0 to 3 scale as follows: (0) Followed rarely or not at all; (1) Followed occasionally; (2) Followed most of the time; (3) Followed consistently. Ratings for all therapeutic elements will be broadly grouped into a Behavioral Component and a Cognitive Component. |
week 2 |
|
Secondary |
Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) |
The DBAS is a 30-item self-report questionnaire designed to evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. The 30-item version showed adequate psychometric properties as evidenced by good internal consistency (Cronbach Alpha = 0.80), moderate item-total correlations (mean rs = 0.37), and adequate convergent and discriminant validity.Likert-type scale requiring participants to choose from 1 to 5 will be used. Thus, the results are quantified in terms of strength of endorsed beliefs. A higher score indicates more dysfunctional beliefs and attitudes about sleep. The total score is based on the average score of all items. |
baseline and 3 months |
|
Secondary |
Changes in Insomnia Severity Index(ISI) |
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. |
baseline,week 2, and 3 months |
|