Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to test the efficacy of a Compassive Acceptance Intervention protocol (developed by the research team) for Chronic Insomnia in comparison with the standard treatment (CBT-I).

Official Title
-----------------
Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

Conditions
-----------------
Chronic Insomnia, CBT

Intervention / Treatment
-----------------
* Behavioral: ACTCOM-I Intervention
* Behavioral: Standard CBT-I Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insomnia Diagnosis (ICSD-3; DSM-5) Exclusion Criteria: Comorbidity with severe psychiatric/psychological disorder (e.g. severe depression; psychotic disorder) Comorbidity with other untreated sleep disorder Altered Sleep patterns due to factors different from insomnia (e.g. shift-work; pregnancy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTCOM-I Intervention<br> | Behavioral: ACTCOM-I Intervention<br>* ACTCOM-I s an individual treatment protocol based on Acceptance and Commitment Therapy (ACT) with targeted behavioral components for insomnia treatment and a specific focus on selfcompassion as a protector for sleep disturbance.<br>|
| Active Comparator: Standard CBT-I Intervention<br> | Behavioral: Standard CBT-I Intervention<br>* Standard CBT-I treatment for chronic insomnia. Treatment protocol adapted from Morin's protocol (1993)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia severity scores | Insomnia severity assessed by the Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire that evaluates the nature, severity, and impact of insomnia. Scores range from 0 to 28 points with higher scores indicating more severe insomnia symptoms. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-sleep arousal scores | Pre-sleep arousal assessed by the Pre-Sleep Arousal Scale (PSAS). The PSAS is a 16-item self-report questionnaire that evaluates symptoms of arousal at bedtime. Eight items evaluate symptoms of cognitive arousal and eight evaluate symptoms of somatic arousal experienced when attempting to fall asleep. Scores range from 8 to 40 in each subscale, where higher scores indicate greater activation. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in sleep effort scores | Sleep effort assessed by the Glasgow Sleep Effort Scale (GSES). The GSES is a 7-item self-report questionnaire that evaluates the presence of a state of sleep effort. Scores range from 0 to 14 where higher scores indicate greater effort to sleep | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in dysfunctional beliefs and attitudes about sleep scores | Dysfunctional beliefs and attitudes about sleep assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS). The DBAS is a 30-item self-report questionnaire that addresses several beliefs and attitudes about sleep and insomnia. A global score is found by averaging scores on all items, with higher scores indicating more dysfunctional beliefs and attitudes about sleep. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in anxiety and depression symptoms scores | Anxiety and depression symptoms assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item self-report questionnaire of which 7 items assess depression and 7 items assess anxiety. Scores range from 0 to 21 for each subscale where higher scores denote higher distress (anxiety and depression). | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in positive and negative affect scores | Assessment of affect using the PANAS Portuguese Short Version (PANAS-VRP). The PANAS-VRP is a 10-item self-report questionnaire of which 5 items evaluate positive affect and 5 items evaluate negative affect. Scores range from 5 to 25 for each subscale where higher scores indicate high positive and negative affect, for each subscale respectively. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in trait mindfulness scores | Assessment of trait mindfulness using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item self-report questionnaire evaluating the trait-like tendency to be mindful in daily life. The scale provides a global mindfulness score (sum of each facet score) and comprises five related facets (observing; describing; acting with awareness; nonjudging; nonreactivity). Facet scores range from 8-40, except for the nonreactivity facet, which ranges from 7-35. Higher scores indicate higher mindfulness trait. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in psychological flexibility scores | Assessment of psychological inflexibility or experiential avoidance using the Acceptance and Action Questionnaire-II (AAQ-II). The AAQ-II is a 7-item self-report questionnaire with total scores ranging from 7 to 49 where higher scores indicate higher levels of psychological inflexibility. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in cognitive fusion scores | Assessment of the process of cognitive fusion using the Cognitive Fusion Questionnaire (CFQ). The CFQ is a 7-item self-report questionnaire that evaluates the degree to which people tend to fuse with their thoughts. Scores range from 7 to 49 points, where higher scores indicate higher levels of cognitive fusion. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in personal values enactment scores | Assessment of one's engagement in valued action (personal values enactment) using the Valuing Questionnaire (VQ). The VQ is a 10-item self-report questionnaire that evaluates how consistently an individual is living according with their chosen values. The scale measures two constructs - progress and obstruction - and each subscale is scored from 0 to 30 points. On the progress subscale, higher scores indicate higher valued based action and, on the obstruction subscale, higher scores denote higher interference with acting according to one's values. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in self-compassion scores | Assessment of self-compassion using the Self-Compassion Scale (SCS). The SCS is a 26-item self-report questionnaire that evaluates the capacity for self-compassion through six subscales (Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; Over-identification). Total scores range from 26 to 130 points. Higher scores indicate higher self-compassion for total scores and subscale scores. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 
| Change in Quality of life scores | Assessment of individual facets relating to quality of life using the World Health Organization Quality Of Life Scale (WHOQOL-BREF). The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Total scores range from 26 to 130 points. Higher scores indicate better satisfaction with quality of life on total score and subscale scores. | Baseline (2 weeks prior the start of treatment), post-treatment (2 weeks after the 10th session - treatment completion), 3 months after treatment completion, 6 months after treatment completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Insomnia, CBT-I, ACT, Compassion