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Acceptance and Commitment Therapy for Insomnia (ACT-I)

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: Acceptance and Commitment Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

Identifiers

NCT04866914
65743917.2.0000.0068

Details and patient eligibility

About

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).

Enrollment

227 patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

227 participants in 3 patient groups

ACT for Insomnia
Experimental group
Treatment:
Behavioral: Acceptance and Commitment Therapy for Insomnia
CBT for Insomnia
Active Comparator group
Treatment:
Behavioral: Cognitive Behavioral Therapy for Insomnia
Wait List
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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