Sleep DisorderNCT04373538
Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
A study testing Trans-C for sleep and circadian function + Memory Support in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
Trial summary
Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Sleep Disorder, Circadian Dysregulation
- What is being tested?
- Trans-C for sleep and circadian function + Memory Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 25 Jun 2021
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years and older
- English language fluency
- Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
Who cannot join
- Presence of an active and progressive mental or physical illness or neurological degenerative disease
- Night shift work >2 nights per week in the past 3 months
- Not able and willing to participate in and/or complete the assessments and participate in the treatment
- Current suicide risk sufficient to preclude treatment on an outpatient basis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720-1650
About this study
Official title: A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 55 years and older to assess if a simplified version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
Read the detailed description
Given the huge burden associated with mental illness, a major challenge ahead is to hasten progress toward developing and testing highly efficient and effective interventions for psychological health problems. Progress toward establishing evidence-based psychosocial treatments for most types of mental illness has been excellent, particularly the cognitive and behavioral treatments (CBT). However, much work remains. The effect sizes are moderate, gains may not persist, and there are patients who derive little or no benefit. Even under optimal conditions, treatment failure is too common. Hence, the challenge is to improve outcomes. Seminal progress toward meeting this challenge must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination).
The proposed research seeks to extend the investigators' program of research on one such innovation. With an R34 and an R01 from NIMH, the investigators have been seeking to improve outcome by improving memory for the content of therapy sessions. To achieve this goal, the investigators have developed and adapted existing findings from the education and cognitive science literatures. The resulting Memory Support Intervention (MSI) involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory.
This line of research arises from several lines of evidence: (a) memory for the content of therapy sessions is poor and (b) memory impairment is modifiable. Although the outcomes will be relevant to psychosocial treatments for a broad range of problems, the focus of this proposal is one treatment for sleep and circadian dysfunction because (a) sleep problems are one of the most prevalent psychological health problems, (b) there is substantial and promising evidence for the efficacy of the transdiagnostic sleep and circadian (TranS-C), yet there is also room for improvement in outcome and (c) sleep problems are associated with memory impairment.
This pilot study will be conducted in order to collect data on individuals who are 55 years and older because memory functioning can decline over this phase of the lifespan. Sleep and circadian problems are also common.
The aim is: To conduct an open trial that includes n = 40 individuals 55 years and older to assess if the Memory Support Intervention (a) improves sleep and circadian functioning, (b) reduces functional impairment and (c) improves patient memory for treatment.
- Conditions
- Sleep Disorder, Circadian Dysregulation
- Being tested
- Trans-C for sleep and circadian function + Memory Support
- Medical subject headings
- Sleep Wake Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-C for sleep and circadian function + Memory SupportBehavioural
The Memory Support Intervention will be delivered interwoven with Trans-C. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Memory Support Intervention | Experimental | Not described Receives: Behavioral: Trans-C for sleep and circadian function + Memory Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Sheehan Disability Scale
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Secondary outcomes (16)
Positive and Negative Affect Scale
Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Perceived Stress Scale
Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Satisfaction with Life Scale
5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life.
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Credibility Expectancy Questionnaire
Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.
Measured: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
Means and Variability of sleep efficiency (Daily Sleep Diary)
Daily Sleep Diary means and variability for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime.
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Composite Sleep Health Score
Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
British Columbia Complaints Inventory
Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mutlidimensional Fatigue Inventory
20-item scale designed to evaluate five dimensions of fatigue. Scores can range from 20-100 with higher total scores corresponding with more acute levels of fatigue
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Cognitive Failures Questionnaire
Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Epworth Sleepiness Scale
Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Memory for Treatment
Recall on the Patient Treatment Recall Task
Measured: At post-treatment, which is 8-10 weeks after the beginning of treatment
Generalization Task Questionnaire
Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life
Measured: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Acceptability Intervention Measure
Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Measured: Through therapy completion, an average of 8 weeks
Intervention Appropriateness Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Measured: Through therapy completion, an average of 8 weeks
Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire
Measured: Through therapy completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 May 2020
- Primary completion15 Jan 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Harvey, University of California, Berkeley
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373538
- Sponsor's protocol ID
- TranS-C and MSI
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
- ClinicalTrials.gov ID
- NCT04373538
- Acronym / sponsor ID
- TranS-C and MSI
- Conditions
- Sleep Disorder, Circadian Dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 4 May 2020 (actual)
- 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.
Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 55 years and older to assess if a simplified version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
Detailed description
Given the huge burden associated with mental illness, a major challenge ahead is to hasten progress toward developing and testing highly efficient and effective interventions for psychological health problems. Progress toward establishing evidence-based psychosocial treatments for most types of mental illness has been excellent, particularly the cognitive and behavioral treatments (CBT). However, much work remains. The effect sizes are moderate, gains may not persist, and there are patients who derive little or no benefit. Even under optimal conditions, treatment failure is too common. Hence, the challenge is to improve outcomes. Seminal progress toward meeting this challenge must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination).
The proposed research seeks to extend the investigators' program of research on one such innovation. With an R34 and an R01 from NIMH, the investigators have been seeking to improve outcome by improving memory for the content of therapy sessions. To achieve this goal, the investigators have developed and adapted existing findings from the education and cognitive science literatures. The resulting Memory Support Intervention (MSI) involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory.
This line of research arises from several lines of evidence: (a) memory for the content of therapy sessions is poor and (b) memory impairment is modifiable. Although the outcomes will be relevant to psychosocial treatments for a broad range of problems, the focus of this proposal is one treatment for sleep and circadian dysfunction because (a) sleep problems are one of the most prevalent psychological health problems, (b) there is substantial and promising evidence for the efficacy of the transdiagnostic sleep and circadian (TranS-C), yet there is also room for improvement in outcome and (c) sleep problems are associated with memory impairment.
This pilot study will be conducted in order to collect data on individuals who are 55 years and older because memory functioning can decline over this phase of the lifespan. Sleep and circadian problems are also common.
The aim is: To conduct an open trial that includes n = 40 individuals 55 years and older to assess if the Memory Support Intervention (a) improves sleep and circadian functioning, (b) reduces functional impairment and (c) improves patient memory for treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory Support Intervention | Experimental | Behavioral: Trans-C for sleep and circadian function + Memory Support |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 55 years and older
- English language fluency
- Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
Key exclusion criteria (4 listed)
- Presence of an active and progressive mental or physical illness or neurological degenerative disease
- Night shift work >2 nights per week in the past 3 months
- Not able and willing to participate in and/or complete the assessments and participate in the treatment
- Current suicide risk sufficient to preclude treatment on an outpatient basis
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 |
|---|---|---|
| Trans-C for sleep and circadian function + Memory SupportThe Memory Support Intervention will be delivered interwoven with Trans-C. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment. | Behavioural | Memory Support Intervention |
Primary outcome
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
Sheehan Disability Scale
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
16 secondary outcomes
Positive and Negative Affect Scale
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Perceived Stress Scale
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Satisfaction with Life Scale
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Credibility Expectancy Questionnaire
Time frame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
Means and Variability of sleep efficiency (Daily Sleep Diary)
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Composite Sleep Health Score
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
British Columbia Complaints Inventory
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mutlidimensional Fatigue Inventory
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Cognitive Failures Questionnaire
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Epworth Sleepiness Scale
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Memory for Treatment
Time frame: At post-treatment, which is 8-10 weeks after the beginning of treatment
Generalization Task Questionnaire
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Acceptability Intervention Measure
Time frame: Through therapy completion, an average of 8 weeks
Intervention Appropriateness Measure
Time frame: Through therapy completion, an average of 8 weeks
Feasibility of Intervention Measure
Time frame: Through therapy completion, an average of 8 weeks
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 29 Sep 2021.
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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.
Allison Harvey, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-C for sleep and circadian function + Memory Support in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley 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 3 inclusion and 4 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 29 Sep 2021. 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?
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.