InsomniaACT-INCT04866914

Acceptance and Commitment Therapy for Insomnia

A study testing Acceptance and Commitment Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Insomnia
What is being tested?: Acceptance and Commitment Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 227 participants
Where: 1 siteBrazil
Study dates: 15 Mar 2021to 15 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Clinical diagnosis of chronic insomnia

Who cannot join

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 locations and contacts

1 site in 1 country.

Brazil1 site

University of Sao Paulo General Hospital.
São Paulo, 05403903

Other trials in Brazil

About this study

Official title: Acceptance and Commitment Therapy for Chronic Insomnia in Adults

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).

Conditions: Insomnia
Being tested: Acceptance and Commitment Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia
Keywords: INSOMNIA, acceptance and commitment therapy, Cognitive behavioral therapy, SLEEP
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acceptance and Commitment Therapy for InsomniaBehavioural
Also called ACT-I
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 InsomniaBehavioural
Also called CBT-I
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.

Study groups in NCT04866914
Study group	Role	What they receive
ACT for Insomnia	Experimental	Not described Receives: Behavioral: Acceptance and Commitment Therapy for Insomnia
CBT for Insomnia	Active comparator	Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia
Wait List	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the score of Insomnia Severity Index (ISI)
Change in the total score of Insomnia Severity Index (ISI)
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.

Secondary outcomes (10)

Remission - categorical variable
a final ISI score under 8 points
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Treatment response - categorical variable
change or reduction in the ISI total score of 8 points or more
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Reduction in Sleep Onset Latency (SOL)
Reduction in Sleep Onset Latency (SOL) measured by sleep diary
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Reduction in Wake After Sleep Onset (WASO)
Reduction in Wake After Sleep Onset (WASO) measured by sleep diary
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Total Sleep Time (TST)
Increase in Total Sleep Time (TST) measured by sleep diary
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Sleep Efficiency (SE)
Increase in Sleep Efficiency (SE) measured by sleep diary
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
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)
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Acceptance and Action Questionnaire-II (AAQ-II)
Change in the the total score of Acceptance and Action Questionnaire-II (AAQ-II)
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Sleep Problem Acceptance Questionnaire (SPAQ)
Change in the the total score of Sleep Problem Acceptance Questionnaire (SPAQ)
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.
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)
Measured: baseline, 7 weeks and 24 weeks after treatment commencement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202115 Mar 2023

First posted30 Apr 2021
Study start15 Mar 2021
Primary completion15 Mar 2023
Study completion15 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04866914
Sponsor's protocol ID: 65743917.2.0000.0068
Acronym: ACT-I
Status last verified: May 2021
First submitted: 13 Apr 2021
Last updated: 9 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome

All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acceptance and Commitment Therapy for Chronic Insomnia in Adults
ClinicalTrials.gov ID: NCT04866914
Acronym / sponsor ID: ACT-I / 65743917.2.0000.0068
Conditions: Insomnia
Keywords: INSOMNIA, acceptance and commitment therapy, Cognitive behavioral therapy, SLEEP
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: University of Sao Paulo General HospitalUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: 15 Mar 2021 (actual)
Primary completion: 15 Mar 2023 (actual)
Study completion: 15 Mar 2023 (actual)
First posted: 30 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ACT for Insomnia	Experimental	Behavioral: Acceptance and Commitment Therapy for Insomnia
CBT for Insomnia	Active comparator	Behavioral: Cognitive Behavioral Therapy for Insomnia
Wait List	No intervention	–

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Clinical diagnosis of chronic insomnia

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acceptance and Commitment Therapy for InsomniaAlso: ACT-IACT-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.	Behavioural	ACT for Insomnia
Cognitive Behavioral Therapy for InsomniaAlso: CBT-IActive 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.	Behavioural	CBT for Insomnia

Primary outcome

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)

10 secondary outcomes

Remission - categorical variable
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Treatment response - categorical variable
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Reduction in Sleep Onset Latency (SOL)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Reduction in Wake After Sleep Onset (WASO)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Total Sleep Time (TST)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Increase in Sleep Efficiency (SE)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Sleep Problem Acceptance Questionnaire (SPAQ)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.
Change in the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
Time frame: baseline, 7 weeks and 24 weeks after treatment commencement.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.

Related trials for Insomnia

Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

RENATHA RAFIHI-FERREIRA, PHD principal investigator

University of Sao Paulo General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the score of Insomnia Severity Index (ISI) (time frame: baseline, 7 weeks and 24 weeks after treatment commencement.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04866914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.