Clinical trial NCT04866914: Acceptance and Commitment Therapy for Insomnia
Official title: Acceptance and Commitment Therapy for Chronic Insomnia in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: INSOMNIA
acceptance and commitment therapy
Cognitive behavioral therapy
SLEEP
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2021-04-30
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is a frequent complaint and is associated with impairments in physical and psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective results for insomnia, there are those who do not respond to this type of intervention or present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as a potentially useful intervention for the treatment of insomnia, for which, instead of focusing on controlling the symptoms, the respective approach focuses on accepting the feelings and thoughts associated, through value-based actions. The aim of this study is to evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150 adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the intervention will be performed in six group and weekly sessions. Assessments of sleep patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep, beliefs about sleep, personality traits will be performed in the pre-treatment, post-treatment and six-month follow-up. After the intervention is completed, participants will respond to an inventory of compliance and satisfaction. Treatment effects will assessed using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated pairwise contrasts to examine changes across time within groups will be used. Variables will analyzed using generalized mixed models (GMM).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic insomnia

Exclusion Criteria:

* Neurological degenerative disease
* Psychotic disorder
* sleep apnea, restless legs or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
* cognitive impairments
* unavailability in attending the sessions.

Primary outcomes:
measure: Change in the score of Insomnia Severity Index (ISI)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary outcomes:
measure: Remission - categorical variable
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Treatment response - categorical variable
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Reduction in Sleep Onset Latency (SOL)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Reduction in Wake After Sleep Onset (WASO)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Increase in Total Sleep Time (TST)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Increase in Sleep Efficiency (SE)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Change in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Change in the Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Change in the Sleep Problem Acceptance Questionnaire (SPAQ)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
measure: Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
timeFrame: baseline, 7 weeks and 24 weeks after treatment commencement.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo General Hospital.
Study officials:
affiliation: University of Sao Paulo General Hospital
name: RENATHA RAFIHI-FERREIRA, PHD
role: PRINCIPAL_INVESTIGATOR
References: