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Completed

NCT Number: NCT04373538

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley

Berkeley, California, 94720-1650, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Trans-C for sleep and circadian function + Memory Support

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. Positive and Negative Affect Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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

  2. Perceived Stress Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress

  3. Satisfaction with Life Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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.

  4. Credibility Expectancy Questionnaire

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

    Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.

  5. 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

    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.

  6. 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

    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).

  7. Composite Sleep Health Score

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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).

  8. British Columbia Complaints Inventory

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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

  9. Mutlidimensional Fatigue Inventory

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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

  10. Cognitive Failures Questionnaire

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    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.

  11. Epworth Sleepiness Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.

  12. Memory for Treatment

    Time frame: At post-treatment, which is 8-10 weeks after the beginning of treatment

    Recall on the Patient Treatment Recall Task

  13. Generalization Task Questionnaire

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life

  14. Acceptability Intervention Measure

    Time frame: Through therapy completion, an average of 8 weeks

    Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire

  15. Intervention Appropriateness Measure

    Time frame: Through therapy completion, an average of 8 weeks

    Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire

  16. Feasibility of Intervention Measure

    Time frame: Through therapy completion, an average of 8 weeks

    Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire

Other outcomes

  1. STOP-BANG Questionnaire

    Time frame: Baseline only

    Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea

  2. Screen for periodic limb movement disorder

    Time frame: Baseline only

    Restless Leg Syndrome Questions

  3. Medication Dosage

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Collect dose, type, frequency and changes in medications

  4. Medication Type

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

  5. Medication Use Frequency

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

  6. Change in Medications

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

  7. Semi-structured interview

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

    Assess patient perceptions of treatment

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Official study title

A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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