Clinical trial NCT06336551: Acceptance and Commitment Therapy for Insomnia
Official title: Efficacy of Acceptance and Commitment Therapy as a Stand-Alone Treatment for Insomnia: Protocol of a Randomized Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Acceptance and Commitment Therapy
ACT-I
stand-alone
efficacy
mechanisms
randomized controlled trial
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Insomnia severity
timeFrame: Change from baseline to 8-weeks post-randomization
Secondary outcomes:
measure: Insomnia severity
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Insomnia severity
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Insomnia severity
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: General well-being
timeFrame: Change from baseline to 4-weeks post-randomization
measure: General well-being
timeFrame: Change from baseline to 8-weeks post-randomization
measure: General well-being
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: General well-being
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep-related quality of life
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep-related quality of life
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep-related quality of life
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep-related quality of life
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Anxiety symptoms
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Anxiety symptoms
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Anxiety symptoms
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Anxiety symptoms
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Depression symptoms
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Depression symptoms
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Depression symptoms
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Depression symptoms
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Psychological flexibility
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Psychological flexibility
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Psychological flexibility
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Psychological flexibility
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Psychological inflexibility
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Psychological inflexibility
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Psychological inflexibility
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Psychological inflexibility
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep-related arousal
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep-related arousal
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep-related arousal
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep-related arousal
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Dysfunctional sleep-related cognitions
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Dysfunctional sleep-related cognitions
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Dysfunctional sleep-related cognitions
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Dysfunctional sleep-related cognitions
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
measure: Sleep-related safety behaviors
timeFrame: Change from baseline to 4-weeks post-randomization
measure: Sleep-related safety behaviors
timeFrame: Change from baseline to 8-weeks post-randomization
measure: Sleep-related safety behaviors
timeFrame: Change from baseline to 3-month follow-up (ACT-I group only)
measure: Sleep-related safety behaviors
timeFrame: Change from baseline to 6-month follow-up (ACT-I group only)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
state: Noord-Holland
Study officials:
affiliation: University of Amsterdam
name: Looman I Mathilde, MSc
role: PRINCIPAL_INVESTIGATOR
References: