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Acceptance and Commitment Therapy for Insomnia

Acceptance and Commitment Therapy for Insomnia

Recruiting
18 years and older
All
Phase N/A

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Overview

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?

Eligibility

Inclusion Criteria:

  • insomnia severity index score ≥ 15
  • clinical insomnia disorder diagnosis, as confirmed by the SCID-S-5 insomnia interview
  • age of 18 years or above
  • proficiency in Dutch
  • ability to come on-site for the treatment sessions

Exclusion Criteria:

  • previously received ACT
  • started psychotherapy within the last 6 months or currently awaiting psychotherapy
  • changed psychoactive medication in the last 3 months
  • diagnosis of psychosis or schizophrenia
  • severe depressive complaints (BDI-II score ≥ 29) or active suicidal ideation

Study details
    Insomnia

NCT06336551

University of Amsterdam

19 May 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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