Evidence map›Paper›PMID 40634991›Full record

Trial reportImplementation science : IS2025

A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the "fit" of psychological treatments by adapting to context.

Allison G Harvey, Emma R Agnew, Rafael Esteva Hache, Julia M Spencer, Marlen Diaz, Estephania Ovalle Patino, Anne Milner, Lu Dong, Amy M Kilbourne, Daniel J Buysse and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Implementation science : IS, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04154631 (Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 1), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04154631 nacompletednot on this map

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health Part 1: Implementation

TypeinterventionalSponsorUniversity of California, BerkeleyRan2020 to 2023Enrolled489ConditionsSleep Disorder, Circadian DysregulationArmsStandard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Usual Care Delayed Treatment
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Allison G HarveyDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US. aharvey@berkeley.edu.
Emma R AgnewDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Rafael Esteva HacheDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Julia M SpencerDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Marlen DiazDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Estephania Ovalle PatinoDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Anne MilnerDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Lu DongRAND Corporation, Santa Monica, CA, US.
Amy M KilbourneDepartment of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA.
Daniel J BuysseUniversity of Pittsburgh, Pittsburgh, PA, US.
Catherine A CallawayDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.
Laurel D SarfanDepartment of Psychology, University of California, 2121 Berkeley Way, Berkeley, CA, 94720, US.

Funding

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment to Improve Severe Mental Illness Outcomes in Community Mental Health.R01MH120147 · NIMH · UNIVERSITY OF CALIFORNIA BERKELEY · PI HARVEY, ALLISON G · 2019 to 2023
$3.9M
Advancing Sustainability of Evidence-Based Treatments in Community Mental HealthF32MH131284 · NIMH · UNIVERSITY OF CALIFORNIA BERKELEY · PI SARFAN, LAUREL D · 2022 to 2024
$76k
NIMH NIH HHS F32 MH131284NIMH NIH HHS F32MH131284NIMH NIH HHS R01 MH120147NIMH NIH HHS R01MH120147
6 · The paper itself

Abstract

backgroundGrounded in the Integrated Promoting Action on Research Implementation in Health Services framework (i-PARIHS) and the Replicating Effective Programs framework (REP), the goal is to determine if the use of theory, data and end-user perspectives to guide an adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC) yields better outcomes and improves the "fit" of TSC to community mental health centers (CMHCs), relative to the standard version.

methodsTen counties in California were cluster-randomized by county to Adapted or Standard TSC. Within each county, adults who exhibited sleep and circadian dysfunction and serious mental illness (SMI) were randomized to immediate TSC or Usual Care followed by Delayed Treatment with TSC (UC-DT). Facilitation was the implementation strategy. The participants were 93 CMHC providers who delivered TSC (Standard = 30; Adapted = 63) and 396 CMHC patients (Standard = 74; Adapted = 124; UC-DT = 198). Patient assessments were completed at pre-treatment, post-treatment, and six months after treatment (6FU). Provider assessments were completed at post-training, mid-treatment, and post-treatment.

resultsTSC (combining Adapted and Standard), relative to UC-DT before delayed treatment with TSC, was associated with improvement from pre- to post-treatment in sleep disturbance (b = -10.91, p < 0.001, d = -1.52), sleep-related impairment (b = -9.52, p < 0.001, d = -1.06), sleep health composite (b = 1.63, p < 0.001, d = 0.95), psychiatric symptoms (b = -6.72, p < 0.001, d = -0.52), and overall functional impairment (b = -5.12, p < 0.001, d = -0.71). TSC's benefits for functional impairment and psychiatric symptoms were mediated by improvements in sleep and circadian problems. Adapted versus Standard TSC did not differ on provider ratings of fit and better fit did not mediate the relation between TSC condition and patient outcome.

conclusionsTSC can be delivered by CMHC providers. Adapted and Standard TSC both fit the CMHC context. These findings are interpreted through the lens of the four core constructs of the i-PARIHS framework.

trial registrationClinicaltrials.gov identifier: NCT04154631. Registered on November 6, 2019. https://clinicaltrials.gov/ct2/show/NCT04154631.

Indexed as

Community Mental Health ServicesMental DisordersSleep Disorders, Circadian RhythmSleep Wake DisordersAdultCaliforniaFemaleHumansImplementation ScienceMaleMiddle AgedAdaptationAnxiety disorderBipolar disorderCircadianCommunity mental healthDepressionFacilitationInsomniaIntegrated Promoting Action on Research Implementation in Health Services framework (i-PARIHS)Mental illnessPsychosisReplicating Effective Programs framework (REP)SleepTransdiagnostic

Identifiers

PMID40634991
PMCPMC12239326

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.