Acceptance and Commitment Therapy for Insomnia

Insomnia Clinical Trial

— ACT-I  

Official title:

Acceptance and Commitment Therapy for Chronic Insomnia in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866914
• Other study ID #: 65743917.2.0000.0068
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Acceptance and Commitment Therapy for Insomnia
ACT-I treatment group: Participants diagnosed with chronic insomnia will receive group treatment. The six sessions will be aimed at psychoeducation about sleep added to the therapeutic processes of acceptance, mindfulness, availability, values, defusion and commitment, used in ACT.
• Cognitive Behavioral Therapy for Insomnia
Active control group CBT-I: Participants diagnosed with chronic insomnia will receive treatment in a group. The six sessions will be aimed at cognitive-behavioral components, such as education and sleep hygiene, stimulus control, sleep restriction and demystification / restructuring of belief beliefs.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital.	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the score of Insomnia Severity Index (ISI)	Change in the total score of Insomnia Severity Index (ISI)	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Remission - categorical variable	a final ISI score under 8 points	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Treatment response - categorical variable	change or reduction in the ISI total score of 8 points or more	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Reduction in Sleep Onset Latency (SOL)	Reduction in Sleep Onset Latency (SOL) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Reduction in Wake After Sleep Onset (WASO)	Reduction in Wake After Sleep Onset (WASO) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Increase in Total Sleep Time (TST)	Increase in Total Sleep Time (TST) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Increase in Sleep Efficiency (SE)	Increase in Sleep Efficiency (SE) measured by sleep diary	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Change in the Hospital Anxiety and Depression Scale (HADS)	Change in the total score for the anxiety variable (HADAS-A) and total score for the depression variable (HADAS-D)	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Change in the Acceptance and Action Questionnaire-II (AAQ-II)	Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Change in the Sleep Problem Acceptance Questionnaire (SPAQ)	Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)	baseline, 7 weeks and 24 weeks after treatment commencement.
Secondary	Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)	Change in the the total score of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)	baseline, 7 weeks and 24 weeks after treatment commencement.