Acceptance and Commitment Therapy for Insomnia

University of Amsterdam

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: Acceptance and Commitment Therapy for insomnia (ACT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT06336551

UniversityAmsterdam

Details and patient eligibility

About

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?

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Acceptance and Commitment Therapy for insomnia (ACT-I)

Experimental group

Description:

In this condition, participants receive five individual face-to-face 60-minute sessions of ACT-I psychotherapy within a 7-week treatment period.

Treatment:

Behavioral: Acceptance and Commitment Therapy for insomnia (ACT-I)

Waitlist control

No Intervention group

Description:

In this condition, participants fill out assessments only during a 7-week waiting period. After completing the post-assessment, participants in the control condition receive ACT-I treatment as well.