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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Study protocol

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial

Authors: Laurel D. Sarfan, Emma R. Agnew, Marlen Diaz, Ashby Cogan, Julia M. Spencer, Rafael Esteva Hache, Shannon Wiltsey Stirman, Cara C. Lewis, Amy M. Kilbourne, Allison G. Harvey

Published in: Trials | Issue 1/2024

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Abstract

Background

Although research on the implementation of evidence-based psychological treatments (EBPTs) has advanced rapidly, research on the sustainment of implemented EBPTs remains limited. This is concerning, given that EBPT activities and benefits regularly decline post-implementation. To advance research on sustainment, the present protocol focuses on the third and final phase—the Sustainment Phase—of a hybrid type 2 cluster-randomized controlled trial investigating the implementation and sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for patients with serious mental illness and sleep and circadian problems in community mental health centers (CMHCs). Prior to the first two phases of the trial—the Implementation Phase and Train-the-Trainer Phase—TranS-C was adapted to fit the CMHC context. Then, 10 CMHCs were cluster-randomized to implement Standard or Adapted TranS-C via facilitation and train-the-trainer. The primary goal of the Sustainment Phase is to investigate whether adapting TranS-C to fit the CMHC context predicts improved sustainment outcomes.

Methods

Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended and may continue for up to one year. CMHC providers will be recruited to complete surveys (N = 154) and a semi-structured interview (N = 40) on sustainment outcomes and mechanisms. Aim 1 is to report the sustainment outcomes of TranS-C. Aim 2 is to evaluate whether manipulating EBPT fit to context (i.e., Standard versus Adapted TranS-C) predicts sustainment outcomes. Aim 3 is to test whether provider perceptions of fit mediate the relation between treatment condition (i.e., Standard versus Adapted TranS-C) and sustainment outcomes. Mixed methods will be used to analyze the data.

Discussion

The present study seeks to advance our understanding of sustainment predictors, mechanisms, and outcomes by investigating (a) whether the implementation strategy of adapting an EBPT (i.e., TranS-C) to the CMHC context predicts improved sustainment outcomes and (b) whether this relation is mediated by improved provider perceptions of treatment fit. Together, the findings may help inform more precise implementation efforts that contribute to lasting change.

Trial registration

ClinicalTrials.gov identifier: NCT05956678. Registered on July 21, 2023.
Appendix
Available only for authorised users
Footnotes
1
Note that the vast majority of providers were employed by CMHCs. However, some providers left their CMHC position during the study. Also, in very few isolated instances, providers outside of CMHCs learned about the study (e.g., by word of mouth) and requested to participate. When the latter providers otherwise met the criteria, they were permitted to participate and were matched with a CMHC patient by the facilitation team. For consistency across phases of the trial and to maximize sample size, these providers (i.e., who left their CMHC after receiving TranS-C training or requested to participate from outside of CMHCs) will be included in Sustainment Phase recruitment efforts.
 
2
The original measure used a 5-point scale from 0 to 4. However, this measure was delivered to providers using a 4-point scale at earlier timepoints in the present trial; thus, a 4-point scale was used for consistency.
 
3
In the original measure [50], the nightmares module was not included due to administrative error. It was added to the version administered to providers in Standard TranS-C (Adapted TranS-C does not include the nightmares module).
 
4
Due to administrative error, this scale deviates from the original scale of 1 to 7.
 
5
Contact information of the sponsor: +1(510) 642-6000; University Avenue and Oxford Street, Berkeley, CA 94702.
 
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Metadata
Title
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial
Authors
Laurel D. Sarfan
Emma R. Agnew
Marlen Diaz
Ashby Cogan
Julia M. Spencer
Rafael Esteva Hache
Shannon Wiltsey Stirman
Cara C. Lewis
Amy M. Kilbourne
Allison G. Harvey
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07900-1

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