Acceptance and Commitment Therapy for Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336551
• Other study ID #: UniversityAmsterdam
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: January 26, 2026

Study information

• Verified date: May 2024
• Source: University of Amsterdam
• Contact: Mathilde I Looman, MSc
• Phone: (0)20 525 6810
• Email: m.i.looman[@]uva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 26, 2026
• Est. primary completion date: January 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Acceptance and Commitment Therapy for insomnia (ACT-I)
During ACT-I patients are encouraged to let go of the struggle to control sleep and to focus on meaningful daytime activities. Treatment goals are addressed through ACT processes of creative hopelessness and self-as-context (session 1), acceptance (session 2), defusion (session 3), followed by values, committed action, and present moment awareness (sessions 4 and 5).

Locations

Country	Name	City	State
Netherlands	University of Amsterdam	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity	Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.	Change from baseline to 8-weeks post-randomization
Secondary	Insomnia severity	Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.	Change from baseline to 4-weeks post-randomization
Secondary	Insomnia severity	Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Insomnia severity	Insomnia severity is assessed with the Insomnia Severity Index (ISI). The ISI consists of seven items evaluating insomnia symptoms on a 5-point scale (range: 0-28). Higher scores indicate greater severity of insomnia symptoms.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	General well-being	General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.	Change from baseline to 4-weeks post-randomization
Secondary	General well-being	General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.	Change from baseline to 8-weeks post-randomization
Secondary	General well-being	General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	General well-being	General well-being is assessed with the Mental Health Continuum Short Form (MHC-SF), which includes 14 items rated on a 6-point scale (range: 0-70). Higher scores indicate greater well-being.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep-related quality of life	Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep-related quality of life	Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep-related quality of life	Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep-related quality of life	Sleep-related quality of life is evaluated using the Glasgow Sleep Impact Index (GSII). Respondents define and rate their three main domains of sleep-related impairment on a Visual Analog Scale (range: 0-100). Higher scores indicate more sleep-related impairment.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Anxiety symptoms	Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.	Change from baseline to 4-weeks post-randomization
Secondary	Anxiety symptoms	Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.	Change from baseline to 8-weeks post-randomization
Secondary	Anxiety symptoms	Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Anxiety symptoms	Anxiety symptoms are assessed with the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), featuring seven items rated on a 4-point scale (range: 0-21). Higher scores indicate more anxiety symptoms.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Depression symptoms	Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.	Change from baseline to 4-weeks post-randomization
Secondary	Depression symptoms	Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.	Change from baseline to 8-weeks post-randomization
Secondary	Depression symptoms	Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Depression symptoms	Depression symptoms are assessed with the Patient Health Questionnaire depression scale (PHQ-9), a nine-item questionnaire scored on a 4-point scale (range: 0-36). Higher scores indicate more depression symptoms.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep diary: total sleep time	Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep diary: total sleep time	Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep diary: total sleep time	Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep diary: total sleep time	Total sleep time (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate higher total sleep time.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep diary: sleep onset latency	Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep diary: sleep onset latency	Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep diary: sleep onset latency	Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep diary: sleep onset latency	Sleep onset latency (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer sleep onset latency.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep diary: wake after sleep onset	Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep diary: wake after sleep onset	Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep diary: wake after sleep onset	Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep diary: wake after sleep onset	Wake after sleep onset (in minutes) is assessed with the consensus sleep diary (CSD). Higher scores indicate longer wake time after sleep onset.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep diary: sleep efficiency	Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep diary: sleep efficiency	Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep diary: sleep efficiency	Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep diary: sleep efficiency	Sleep efficiency (in percentage) is assessed with the consensus sleep diary (CSD), calculated as the total sleep time*100 divided by the time in bed. Higher scores indicate higher sleep efficiency.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Psychological flexibility	Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.	Change from baseline to 4-weeks post-randomization
Secondary	Psychological flexibility	Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.	Change from baseline to 8-weeks post-randomization
Secondary	Psychological flexibility	Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Psychological flexibility	Psychological flexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological flexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological flexibility.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Psychological inflexibility	Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.	Change from baseline to 4-weeks post-randomization
Secondary	Psychological inflexibility	Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.	Change from baseline to 8-weeks post-randomization
Secondary	Psychological inflexibility	Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Psychological inflexibility	Psychological inflexibility is assessed with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). The subscale psychological inflexibility consists of 12 items, scored on a 6-point scale (range: 12-72). Higher scores indicate greater psychological inflexibility.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep-related arousal	Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep-related arousal	Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep-related arousal	Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep-related arousal	Sleep-related arousal will be assessed with the Pre-Sleep Arousal Scale (PSAS), which comprises 16 items scored on a 5-point scale (range: 16-80). Higher scores indicate higher sleep-related arousal.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Dysfunctional sleep-related cognitions	Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.	Change from baseline to 4-weeks post-randomization
Secondary	Dysfunctional sleep-related cognitions	Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.	Change from baseline to 8-weeks post-randomization
Secondary	Dysfunctional sleep-related cognitions	Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Dysfunctional sleep-related cognitions	Dysfunctional sleep-related cognitions will be evaluated by the short form of the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16), which includes 16 items scored on an 11-point agreement scale (range: 0-160). Higher scores indicate more dysfunctional sleep-related cognitions.	Change from baseline to 6-month follow-up (ACT-I group only)
Secondary	Sleep-related safety behaviors	Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.	Change from baseline to 4-weeks post-randomization
Secondary	Sleep-related safety behaviors	Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.	Change from baseline to 8-weeks post-randomization
Secondary	Sleep-related safety behaviors	Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.	Change from baseline to 3-month follow-up (ACT-I group only)
Secondary	Sleep-related safety behaviors	Sleep-related safety behaviors will be measured with the sleep-related behaviors questionnaire short form (SRBQ-20), which consists of 20 items on coping with fatigue or improving sleep, scored on a 5-point scale (range: 0-80), with higher scores indicating more sleep-related safety behavior.	Change from baseline to 6-month follow-up (ACT-I group only)