Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University of Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Mathilde I Looman, MSc
m.i.looman@uva.nl
(0)20 525 6810
Backup
Jaap Lancee, PhD
j.lancee@uva.nl
(0)20 525 6810
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2026-01-26
Participants
Target number of participants: 80
Treatments
Experimental: Acceptance and Commitment Therapy for insomnia (ACT-I)
In this condition, participants receive five individual face-to-face 60-minute sessions of ACT-I psychotherapy within a 7-week treatment period.
No_intervention: Waitlist control
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.
Related Therapeutic Areas
Sponsors
Leads: University of Amsterdam

This content was sourced from clinicaltrials.gov