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NCT Number: NCT04866914

Acceptance and Commitment Therapy for Insomnia

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).

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo General Hospital.

São Paulo, 05403903, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acceptance and Commitment Therapy for Insomnia

Behavioral

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.

Other names: ACT-I

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Other names: CBT-I

Primary outcomes

  1. Change in the score of Insomnia Severity Index (ISI)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Change in the total score of Insomnia Severity Index (ISI)

Secondary outcomes

  1. Remission - categorical variable

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    a final ISI score under 8 points

  2. Treatment response - categorical variable

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    change or reduction in the ISI total score of 8 points or more

  3. Reduction in Sleep Onset Latency (SOL)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Reduction in Sleep Onset Latency (SOL) measured by sleep diary

  4. Reduction in Wake After Sleep Onset (WASO)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Reduction in Wake After Sleep Onset (WASO) measured by sleep diary

  5. Increase in Total Sleep Time (TST)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Increase in Total Sleep Time (TST) measured by sleep diary

  6. Increase in Sleep Efficiency (SE)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Increase in Sleep Efficiency (SE) measured by sleep diary

  7. Change in the Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Change in the total score for the anxiety variable (HADAS-A) and total score for the depression variable (HADAS-D)

  8. Change in the Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)

  9. Change in the Sleep Problem Acceptance Questionnaire (SPAQ)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)

  10. Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)

    Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

    Change in the the total score of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Acceptance and Commitment Therapy for Chronic Insomnia in Adults

Acronym: ACT-I

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2021
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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