NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of California, Berkeley

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 50 years and older;

English language fluency;

Experiencing a mobility impairment;

Low income;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Memory Support Intervention

    Behavioral

    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.

  • Transdiagnostic Intervention for Sleep and Circadian Dysfunction

    Behavioral

    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.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: TranS-C+MSIExperimental treatment 2 interventions
Group B: TranS-C aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 to 6-month follow-up to 12-month follow-up
2

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 to 6-month follow-up to 12-month follow-up
3

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 to 6-month follow-up to 12-month follow-up

Secondary outcomes

1

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 to 6-month follow-up to 12-month follow-up
2

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 to 6-month follow-up to 12-month follow-up
3

WHODAS 2.0

A measure of functional 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
4

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 to 6-month follow-up to 12-month follow-up

Other outcomes

1

WatchPAT One

For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility

Time frame
Baseline only
2

Adverse events checklist

To assess any adverse events experienced as a result of participating in the study

Time frame
Only at post-treatment which is 8-10 weeks after the beginning of treatment
3

Montreal Cognitive Assessment (MoCA)

A measure of cognitive functioning/cognitive impairments to determine eligibility

Time frame
Baseline only
4

Adapted Credibility Expectancy Questionnaire

Measures the credibility and expectation of improvement from the treatment.

Time frame
At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment

Sponsors and contacts

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