Clinical trial NCT05555108: Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT
Official title: Mindfulness and Compassive Acceptance for Chronic Insomnia in Comparison With CBT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Insomnia
CBT
Keywords: Chronic Insomnia
CBT-I
ACT
Compassion
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Change in insomnia severity scores
timeFrame: 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 outcomes:
measure: Change in pre-sleep arousal scores
timeFrame: 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
measure: Change in sleep effort scores
timeFrame: 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
measure: Change in dysfunctional beliefs and attitudes about sleep scores
timeFrame: 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
measure: Change in anxiety and depression symptoms scores
timeFrame: 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
measure: Change in positive and negative affect scores
timeFrame: 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
measure: Change in trait mindfulness scores
timeFrame: 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
measure: Change in psychological flexibility scores
timeFrame: 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
measure: Change in cognitive fusion scores
timeFrame: 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
measure: Change in personal values enactment scores
timeFrame: 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
measure: Change in self-compassion scores
timeFrame: 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
measure: Change in Quality of life scores
timeFrame: 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
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro de Medicina do Sono do Centro Hospitalar e Universitário de Coimbra
Study officials:
References: