InsomniaNCT02117388
Treatments for Insomnia: Mediators, Moderators and Quality of Life
A study testing Sleep Restriction, Cognitive Behavioral Therapy and Combined Therapy in people with Insomnia, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Restriction, Cognitive Behavioral Therapy and Combined Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females of any racial or ethnic group, aged 60 years old or older
- Independent living (not in nursing home, etc.)
- English-speaking
- Subjective complaint of insomnia associated with daytime impairment or distress
- DSM 5 (Diagnostic and Statistical Manual V) diagnosis of insomnia
- Score >10 on the Insomnia Severity Indexa
- Must live within 40 miles of Stanford University
Who cannot join
- Montreal Cognitive Assessment Scale <20
- Apnea-hypopnea index >10 or Periodic limb movement associated arousals > 5 per hour
- Use of medication specifically prescribed for sleep and unwilling or unable to discontinue > one week prior to baseline data collection.
- Acute or unstable chronic illness: including but not limited to insulin dependent diabetes (adult onset diabetes, controlled with oral medications or diet is acceptable); uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; conditions associated with chronic pain such as fibromyalgia; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months.
- Use of CNS (central nervous system) active medications that would significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (> 4 weeks).
- Excessive caffeine consumption (≥ three cups per day), excessive alcohol consumption (> 14 drinks per week or > 4 drinks per occasion), or illicit substances (by self-report).
- Major psychiatric diagnosis on Axis I of DSM-IV as tested by the Mini International Neuropsychiatric Interview (Version 5.0).
- Lives more than 40 miles from Stanford University
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).
Read the detailed description
As many as one in three older adults may experience insomnia. Older adults are the most frequent users of hypnotic medications. Although safer, use of even the latest "sleeping pills" can lead to cognitive impairment and risk of falls. Thus, it is not surprising that non-pharmacological treatments for insomnia have been pursued as alternatives to medications, with some suggesting they should be the "first line of therapy". We propose a randomized clinical trial to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia (CBT-I): sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the proposed mechanisms of action of CT versus SR substantially differ, their combination may have additive effects. Even though the mechanisms of action of SR and CT may differ, no data exists to document that the addition of one to the other provides more overall clinical benefit than either intervention alone. Finally, to better understand "how" and "in whom" SR and CT work, we plan to formally evaluate selected mediators and moderators of the clinical effect including physiological measures of anxiety and arousal. Three treatments (SR, CT, and SR+CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after 6 weeks of treatment, and at the end of a 6-month follow-up. These efforts follow the National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative interventions and designs for intervention studies, in this case, to promote a new intervention trial that focuses on the mediators and moderators of treatment response.
- Conditions
- Insomnia
- Being tested
- Sleep Restriction, Cognitive Behavioral Therapy, Combined Therapy
- Keywords
- Older adults, insomnia, CBT-I (cognitive behavioral therapy-insomnia), Behavioral Therapy, SRT (sleep restriction therapy), Cognitive Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep.
Combined TherapyBehavioural
Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. Receives: Behavioral: Cognitive Behavioral Therapy |
| Sleep Restriction | Experimental | Sleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly. Receives: Behavioral: Sleep Restriction |
| Combined Therapy Treatment for Insomnia | Experimental | Combined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other. Receives: Behavioral: Combined Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Subject's subjective evaluation of their sleep.
Measured: Screening, End of 6-week treatment, 6-month follow-up
Secondary outcomes (2)
Cognitive Arousal
Score on Penn State Worry Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep Scale.
Both measures have been found to be successful in measuring mediators and moderators of treatment response.
Measured: Screening, end of 6-week treatment, 6-month followup
Chronic Stress
We are using two of the most widely utilized psychometric indices of past, present and chronic stress exposure: 1) the Trauma History Questionnaire, and 2) the Life Stressor Checklist revised, a clinical interview for lifetime exposure to stressful life events.
Measured: Screening, end of 6-week treatment, 6-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startSep 2013
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), US Department of Veterans Affairs
- Responsible party
- Principal investigator, Jerome Yesavage, Palo Alto Veterans Institute for Research
- Investigators
- Jerome A. Yesavage, MD, Principal investigator, VA/Stanford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117388
- Sponsor's protocol ID
- 27264
- Other IDs
- 1R01MH101468-01
- Status last verified
- Sep 2019
- First submitted
- 4 Feb 2014
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ahmadi M, Krause AJ, O'Hora KP, Blozyte-Sakenis E, Hernandez B, Lazzeroni LC, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage J, Saletin JM, Goldstein-Piekarski AN. The association between slow wave activity and memory improvement following cognitive-behavioral therapy for insomnia in older adults: A secondary analysis of a randomized clinical trial . J Clin Sleep Med. 2026 Jun 16;22(1):93. doi: 10.1007/s44470-026-00087-7.
PubMed 42303834O'Hora KP, Morehouse AB, Hernandez B, Burda KF, Babros MC, Lazzeroni L, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage JA, Goldstein-Piekarski AN. Cognitive status moderates long-term benefits of non-pharmacological insomnia therapy in older adults: A secondary analysis of a randomized clinical trial. Alzheimers Dement. 2026 Jun;22(6):e71371. doi: 10.1002/alz.71371.
PubMed 42271184O'Hora KP, Morehouse AB, Freidman L, Posner D, Ahmadi M, Hernandez B, Burda KF, Kushida C, Zeitzer JM, Lazzeroni LC, Manber R, Yesavage J, Goldstein-Piekarski AN. Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older adults: main outcomes of a randomized dismantling trial. J Clin Sleep Med. 2025 Oct 1;21(10):1679-1695. doi: 10.5664/jcsm.11756.
PubMed 40476601
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments for Insomnia: Mediators, Moderators and Quality of Life
- ClinicalTrials.gov ID
- NCT02117388
- Acronym / sponsor ID
- 27264
- Conditions
- Insomnia
- Keywords
- Older adults, insomnia, CBT-I (cognitive behavioral therapy-insomnia), Behavioral Therapy, SRT (sleep restriction therapy), Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), US Department of Veterans Affairs
- Study start
- Sep 2013 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).
Detailed description
As many as one in three older adults may experience insomnia. Older adults are the most frequent users of hypnotic medications. Although safer, use of even the latest "sleeping pills" can lead to cognitive impairment and risk of falls. Thus, it is not surprising that non-pharmacological treatments for insomnia have been pursued as alternatives to medications, with some suggesting they should be the "first line of therapy". We propose a randomized clinical trial to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia (CBT-I): sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the proposed mechanisms of action of CT versus SR substantially differ, their combination may have additive effects. Even though the mechanisms of action of SR and CT may differ, no data exists to document that the addition of one to the other provides more overall clinical benefit than either intervention alone. Finally, to better understand "how" and "in whom" SR and CT work, we plan to formally evaluate selected mediators and moderators of the clinical effect including physiological measures of anxiety and arousal. Three treatments (SR, CT, and SR+CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after 6 weeks of treatment, and at the end of a 6-month follow-up. These efforts follow the National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative interventions and designs for intervention studies, in this case, to promote a new intervention trial that focuses on the mediators and moderators of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. |
| Sleep Restriction | Experimental | Behavioral: Sleep RestrictionSleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly. |
| Combined Therapy Treatment for Insomnia | Experimental | Behavioral: Combined TherapyCombined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females of any racial or ethnic group, aged 60 years old or older
- Independent living (not in nursing home, etc.)
- English-speaking
- Subjective complaint of insomnia associated with daytime impairment or distress
- DSM 5 (Diagnostic and Statistical Manual V) diagnosis of insomnia
Key exclusion criteria (8 listed)
- Montreal Cognitive Assessment Scale <20
- Apnea-hypopnea index >10 or Periodic limb movement associated arousals > 5 per hour
- Use of medication specifically prescribed for sleep and unwilling or unable to discontinue > one week prior to baseline data collection.
- Acute or unstable chronic illness: including but not limited to insulin dependent diabetes (adult onset diabetes, controlled with oral medications or diet is acceptable); uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; conditions associated with chronic pain such as fibromyalgia; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months.
- Use of CNS (central nervous system) active medications that would significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (> 4 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep RestrictionSleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly. | Behavioural | Sleep Restriction |
| Cognitive Behavioral TherapyCognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. | Behavioural | Cognitive Behavioral Therapy |
| Combined TherapySleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other. | Behavioural | Combined Therapy Treatment for Insomnia |
Primary outcome
Insomnia Severity Index
Time frame: Screening, End of 6-week treatment, 6-month follow-up
Subject's subjective evaluation of their sleep.
2 secondary outcomes
Cognitive Arousal
Time frame: Screening, end of 6-week treatment, 6-month followup
Chronic Stress
Time frame: Screening, end of 6-week treatment, 6-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 42303834Ahmadi M, Krause AJ, O'Hora KP, Blozyte-Sakenis E, Hernandez B, Lazzeroni LC, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage J, Saletin JM, Goldstein-Piekarski AN. The association between slow wave activity and memory improvement following cognitive-behavioral therapy for insomnia in older adults: A secondary analysis of a randomized clinical trial . J Clin Sleep Med. 2026 Jun 16;22(1):93. doi: 10.1007/s44470-026-00087-7.
- Derived from this study: PubMed 42271184O'Hora KP, Morehouse AB, Hernandez B, Burda KF, Babros MC, Lazzeroni L, Zeitzer JM, Friedman L, Posner D, Kushida C, Manber R, Yesavage JA, Goldstein-Piekarski AN. Cognitive status moderates long-term benefits of non-pharmacological insomnia therapy in older adults: A secondary analysis of a randomized clinical trial. Alzheimers Dement. 2026 Jun;22(6):e71371. doi: 10.1002/alz.71371.
- Derived from this study: PubMed 40476601O'Hora KP, Morehouse AB, Freidman L, Posner D, Ahmadi M, Hernandez B, Burda KF, Kushida C, Zeitzer JM, Lazzeroni LC, Manber R, Yesavage J, Goldstein-Piekarski AN. Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older adults: main outcomes of a randomized dismantling trial. J Clin Sleep Med. 2025 Oct 1;21(10):1679-1695. doi: 10.5664/jcsm.11756.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome A. Yesavage, MD principal investigator
VA/Stanford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction, Cognitive Behavioral Therapy and Combined Therapy in people with Insomnia, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Screening, End of 6-week treatment, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02117388, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.