Clinical trial NCT04373538: Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
Official title: A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Circadian Dysregulation
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Sheehan Disability Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Secondary outcomes:
measure: Positive and Negative Affect Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Perceived Stress Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Satisfaction with Life Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Credibility Expectancy Questionnaire
timeFrame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
measure: Means and Variability of sleep efficiency (Daily Sleep Diary)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Composite Sleep Health Score
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: British Columbia Complaints Inventory
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Mutlidimensional Fatigue Inventory
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Cognitive Failures Questionnaire
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Memory for Treatment
timeFrame: At post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Generalization Task Questionnaire
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Acceptability Intervention Measure
timeFrame: Through therapy completion, an average of 8 weeks
measure: Intervention Appropriateness Measure
timeFrame: Through therapy completion, an average of 8 weeks
measure: Feasibility of Intervention Measure
timeFrame: Through therapy completion, an average of 8 weeks
Other outcomes:
measure: STOP-BANG Questionnaire
timeFrame: Baseline only
measure: Screen for periodic limb movement disorder
timeFrame: Baseline only
measure: Medication Dosage
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Medication Type
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Medication Use Frequency
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Change in Medications
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Semi-structured interview
timeFrame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: