An interventional study of Trans-C for sleep and circadian function + Memory Support in Sleep Disorder and Circadian Dysregulation, sponsored by University of California, Berkeley. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Health services research
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.
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 28 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University of California, Berkeley is the lead sponsor of 106 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Trans-C for sleep and circadian function + Memory Support
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.
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).
Time frame: 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
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
Time frame: 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
Time frame: 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.
Time frame: 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.
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)
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.
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
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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through therapy completion, an average of 8 weeks
STOP-BANG Questionnaire
Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea
Time frame: Baseline only
Screen for periodic limb movement disorder
Restless Leg Syndrome Questions
Time frame: Baseline only
Medication Dosage
Collect dose, type, frequency and changes in medications
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Medication Type
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Medication Use Frequency
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Change in Medications
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Semi-structured interview
Assess patient perceptions of treatment
Time frame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Berkeley