Cognitive Stimulation and Sleep Quality. An Innovative Intervention for Insomnia

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are a) to investigate the effect of a personalized and computerized cognitive stimulation program on sleep quality, cognitive performance, and quality of life; and b) verify if cognitive stimulation can be used as a non-pharmacological alternative to improve the quality of sleep in individuals who have insomnia.

Detailed Description
-----------------
Phase I/II was designed to determine the safety of the training, the maximum tolerated training time per session, and the needed training sessions to obtain significant cognitive performance improvement prior to beginning with the cognitive stimulation intervention program (Phase III). Phase I/II Through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, 20 participants will engage in a 15-day training effectiveness assessment. An evaluation day and a training day will be interspersed so that participants will complete a total of 7 training sessions (days 2, 4, 6, 8, 10, 12, and 14) and 8 evaluation sessions (days 1, 3, 5, 7, 9, 11, 13, and 15). A psychologist will be supervising every step of the process at all times. Phase III A total of 120 persons with insomnia will undergo an 8-week cognitive stimulation program, five consecutive days per week. Eligible participants will be randomized in a 1:1 ratio to an intervention or control group. Activities duration per day will be as set on phase I. This final phase is set to be an online home-based stage, although the responsible psychologist will periodically contact participants via telephone.

Official Title
-----------------
Cognitive Stimulation Intervention Program for Insomniacs and Its Benefit on Sleep Quality, Executive Functions and Quality of Life

Conditions
-----------------
Insomnia, Insomnia Type; Sleep Disorder

Intervention / Treatment
-----------------
* Other: Personalized cognitive stimulation
* Other: Sham cognitive stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be diagnosed by Insomnia Disorder [307.42 (F51.01)]: A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.) Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.) Early-morning awakening with inability to return to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. C. The sleep difficulty occurs at least 3 nights per week. D. The sleep difficulty is present for at least 3 months. E. The sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia). G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication). H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia. Exclusion Criteria: Have another sleep-wake disorder (e.g., narcolepsy, restless leg syndrome, a breathing-related sleep disorder, a circadian sleep-wake rhythm disorder, a parasomnia). Presence of a relevant medical, psychiatric or neurological disorder. Significant visual or motor impairments. History of alcohol or drug abuse or dependence. Caffeine consumption (more than 150mg per day, that is, approximately 3 cups of espresso or a cup of American coffee). Alcohol consumption (more than 250ml per day, that is, around a pint of beer, a glass of wine, or a shot of liquor). Use of medications with stimulant action, except sedatives or hypnotics prescribed for sleep.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The intervention will be carried out through the CogniFit® online platform so participants will access it from home using a personal computer or smart device. The training will last for a total of 8 weeks (40 training sessions), with five consecutive training days per week (Monday to Friday). Since this process is autonomous, participants will be contacted periodically (a minimum of one phone call per week) to ensure adherence and check that they have not had any incidence. The platform will records participants' performance, providing researchers with real-time feedback on the performance of each participant.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Activities are designed to target specific cognitive skills (attention, perception, inhibition). An internal algorithm of the cognitive stimulation platform will adjust the activities' difficulty depending on the participant's performance, always demanding a maximum cognitive effort. | Other: Personalized cognitive stimulation<br>* Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Performance feedback will be shown after each activity.<br>* Other names: CogniFit's personalized brain training;|
| Active Comparator: Control Group<br>Painting and artistic activities not designed to target specific cognitive skills. The internal algorithm will be deactivated, so the cognitive stimulation activities will be of constant difficulty throughout the intervention. | Other: Sham cognitive stimulation<br>* Non-therapeutic online games based on artistic and creative tasks. Activities will match in duration to those of the experimental intervention. Performance feedback will be shown after each game.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Sleep quality on the Pittsburgh Sleep Quality Index at Week 8 | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a global score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 
| Change from Baseline in Insomnia on the Insomnia Severity Index at Week 8 | The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Possible scores ranges from 0 (No clinically significant insomnia) to 28 (Clinically insomnia - Severe). Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 
| Change from Baseline in Quality of life on Measuring Quality of Life | The World Health Organization - abridged version | The Measuring Quality of Life | The World Health Organization - abridged version (WHOQOL-BREF) is a generic questionnaire to measure the quality of life created by the Study Group on Quality of Life of the World Health Organization. It has 26 questions, two general questions on the quality of life and satisfaction with the state health, and 24 questions grouped into four areas or domains: Physical Health, Psychological Health, Social Relations and Environment. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval. Possible scores for each domain ranges from 0 (poor perceived quality of life) to 100 (greater perceived quality of life). Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Executive function on Behavior Rating Inventory of Executive Function-Adult Version at Week 8 | The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a standardised measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Only the self-report format will be used. The BRIEF-A is composed of 75 items within nine theoretically and empirically derived clinical scales that measure various aspects of executive functioning; Inhibit, Self-Monitor, Plan/Organise, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, Organisation of Materials. The clinical scales form two broader indexes: Behavioral Regulation (BRI) and Metacognition (MI), and these indexes form the overall summary score, the Global Executive Composite (GEC). Also includes three validity scales (Negativity, Inconsistency, and Infrequency). It takes approximately 10-15 minutes to administer. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). Raw scores for each scale are summed | 1 day before starting the intervention and 1 day after finishing the intervention | 
| Change from Baseline in Depressive symptoms on The Beck Depression Inventory-II at Week 8 | The Beck Depression Inventory-II (BDI-II) is a 21-item, self-report inventory designed to measure the frequency and severity of depressive symptoms. Items include somatic-affective symptoms as well as cognitive symptoms. Possible scores ranges from 0 (no depressive symptoms) to 63 (severe depression). Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 
| Change from Baseline in Anxiety symptoms on the State-Trait Anxiety Inventory at Week 8 | The State-Trait Anxiety Inventory (STAI) is a self-report that assesses two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Only the 20 items referred to state anxiety will be administered. Possible scores ranges from 0 (no anxiety) to 60 (severe anxiety). Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 
| Change from Baseline in worrying on The Penn State Worry Questionnaire at Week 8 | The Penn State Worry Questionnaire (PSWQ) is a 16-item questionnaire that aims to measure the trait of worry. The items on the scale assess the occurrence, intrusiveness, pervasiveness, and other characterizing features of an individual's experience with worry. The scale has been shown to identify worry, over and above anxiety and depression. Items are rated on a five-point scale: 1-Not at all typical of me to 5-Very typical of me. Possible scores ranges from 16 (low worry) to 80 (high worry). Change = (Week 8 Score - Baseline Score). | 1 day before starting the intervention and 1 day after finishing the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Cognitive stimulation, Cognitive intervention, Sleep disorder, Sleep quality