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Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT (ACTCOM-I)

Primary Purpose

Chronic Insomnia, CBT

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
ACTCOM-I Intervention
Standard CBT-I Intervention
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Chronic Insomnia, CBT-I, ACT, Compassion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Centro de Medicina do Sono do Centro Hospitalar e Universitário de CoimbraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACTCOM-I Intervention

Standard CBT-I Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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).
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 30, 2022
Last Updated
September 22, 2022
Sponsor
University of Coimbra
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1. Study Identification

Unique Protocol Identification Number
NCT05555108
Brief Title
Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT
Acronym
ACTCOM-I
Official Title
Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, CBT
Keywords
Chronic Insomnia, CBT-I, ACT, Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACTCOM-I Intervention
Arm Type
Experimental
Arm Title
Standard CBT-I Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
ACTCOM-I Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard CBT-I Intervention
Intervention Description
Standard CBT-I treatment for chronic insomnia. Treatment protocol adapted from Morin's protocol (1993)
Primary Outcome Measure Information:
Title
Change in insomnia severity scores
Description
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.
Time Frame
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 Measure Information:
Title
Change in pre-sleep arousal scores
Description
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.
Time Frame
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
Title
Change in sleep effort scores
Description
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
Time Frame
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
Title
Change in dysfunctional beliefs and attitudes about sleep scores
Description
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.
Time Frame
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
Title
Change in anxiety and depression symptoms scores
Description
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).
Time Frame
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
Title
Change in positive and negative affect scores
Description
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.
Time Frame
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
Title
Change in trait mindfulness scores
Description
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.
Time Frame
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
Title
Change in psychological flexibility scores
Description
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.
Time Frame
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
Title
Change in cognitive fusion scores
Description
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.
Time Frame
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
Title
Change in personal values enactment scores
Description
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.
Time Frame
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
Title
Change in self-compassion scores
Description
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.
Time Frame
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
Title
Change in Quality of life scores
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana M Mendes
Phone
925268951
Email
mariana.miller.mendes@gmail.com
Facility Information:
Facility Name
Centro de Medicina do Sono do Centro Hospitalar e Universitário de Coimbra
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda M Clemente, Master
Phone
239 800 120
Email
vandaclem@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT

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