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NCT06336551Recruiting

Acceptance and Commitment Therapy for Insomnia

Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial
University of AmsterdamClinicalTrials.govbehavioral
Study focus
Disease/Condition
Insomnia
Drug/Device/Intervention
Acceptance and Commitment Therapy for insomnia (ACT-I)
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
University of Amsterdam
Location
Amsterdam, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Apr 02, 2024
End date
Jan 26, 2026
Enrollment
80 participants
Primary outcome

Insomnia severity

Summary

Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance
 and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for
 insomnia. However, its effectiveness without overlapping behavioral components of the current
 standard treatment, cognitive behavioral therapy, remains largely unknown.
 
 The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults
 with insomnia, compared to a waitlist control group. The second goal is to explore the
 potential working mechanisms of ACT-I, using network intervention analysis.
 
 Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I
 treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4
 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I
 group.
 
 The main questions this RCT aims to answer are:
 
 - Is ACT-I superior to a waitlist control group in improving insomnia severity (primary
 outcome) in addition to sleep diary measures, anxiety, depression, general mental
 health, and sleep-related quality of life (secondary outcomes)?
 
 - How do networks of insomnia symptoms or potential treatment processes (i.e.,
 psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and
 sleep-related safety behaviors) develop during and following ACT-I?

ICD-10 classifications
Nonorganic insomniaDisorders of initiating and maintaining sleep [insomnias]Sleep disordersSleep disorder, unspecifiedOther sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06336551
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06336551 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Amsterdam and is currently Recruiting. The study focuses on Insomnia. Target enrollment is 80 participants.

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