NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Memory Support Intervention, Transdiagnostic Intervention for Sleep and Circadian Dysfunction.
- Who it may be relevant to
- Registry conditions: Sleep Disorder, Circadian Dysregulation, Memory Impairment. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment
Overview
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 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
Detailed description
Life expectancy has increased drastically in the United States. Longer life is too often associated with illness, discomfort, disability, and dependency. Progress toward promoting health and well-being as we age must include the identification of novel treatment targets that are safe, powerful, inexpensive, and deployable. The proposed research will test one such target-patient memory for the contents of treatment.
Over 5 years, we will recruit adults who are 50 years and older and who are experiencing sleep and circadian problems (n = 178, including 20% for attrition). Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight 50-minute, weekly, individual sessions. Assessments will be conducted at baseline, post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).
Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian functioning, (b) improves daytime functioning, (c) improves well-being and (d) improves patient memory by comparing the effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.
Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be associated with better memory for treatment relative to TranS-C alone, and in turn, better memory for treatment will be associated with better sleep and circadian functioning immediately following treatment and at 6FU and 12FU.
Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3. Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older, have fewer years of education, poorer baseline cognitive functioning and more severe baseline sleep disruption and sleep-related impairment.
Exploratory analyses will compare the treatments on (a) patient adherence as well as patient-rated treatment credibility and utilization of treatment elements and (b) provider-rated acceptability, appropriateness, and feasibility.
Interventions
- Behavioral Memory Support Intervention
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 - Behavioral Transdiagnostic Intervention for Sleep and Circadian Dysfunction
TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.
Primary outcome measures
- 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 to 6-month follow-up to 12-month follow-up]
- Sheehan Disability Scale [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Satisfaction with Life Scale [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
Secondary outcome measures (12)
- 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 to 6-month follow-up to 12-month follow-up]
- Positive and Negative Affect Scale [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- WHODAS 2.0 [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Cognitive Failures Questionnaire [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Epworth Sleepiness Scale [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Memory for Treatment: Cumulative recall [Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]]
- Thoughts and Applications Task [Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]]
- Adapted Utilization Scale [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Composite Sleep Health Score [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Mean sleep efficiency (Daily Sleep Diary) [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Mean total wake time (Daily Sleep Diary) [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
- Mean for total sleep time (Daily Sleep Diary) [Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up]
Eligibility criteria
Inclusion criteria
- Aged 50 years and older;
- English language fluency;
- Experiencing a mobility impairment;
- Low income;
- 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.
- 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
- Able/willing to give informed consent.
Exclusion criteria
- Severe untreated sleep disordered breathing (AHI>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale >10);
- Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
- Homelessness;
- Night shift work >2 nights per week in the past 3 months;
- Substance abuse/dependence only if it makes participation in the study unfeasible;
- Suicide risk sufficient to preclude treatment on an outpatient basis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Berkeley — Berkeley
Publications
- Milner AE, Hache RE, Oliver S, Sarfan LD, Spencer JM, Cogan A, Jiang Y, Agnew ER, Zieve GG, Martin JL, Zeidler MR, Dong L, Carpenter JK, Varghese J, Bol K, Bajwa Z, Tighe CA, Harvey AG. Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcom PMID 39363383
Identifiers
NCT: NCT05986604 · TranS-C+MSI vs. TranS-C Alone