Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review

Prowse, Phuong-Tu; Nagel, Tricia; Meadows, Graham; Enticott, Joanne

doi:10.4172/psychiatry.1000258

Cited by 5 publications

(1 citation statement)

References 56 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These challenges are common in psychotherapy trials. [35][36][37][38] The very low adherence to fluoxetine (26.8%) led to insufficient power, though its timing (6 months postbaseline) may have been too delayed to protect against transition to psychosis. 22 Despite the moderate fidelity to CBCM, findings indicate that the greater the change in cognitive biases or vulnerabilities, the greater the clinical improvement across both treatment groups, suggesting the psychological target of CBCM may represent more of an outcome rather than mediating variable.…”

Section: Discussionmentioning

confidence: 99%

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

McGorry,

Mei,

Amminger

et al. 2023

JAMA Psychiatry

View full text Add to dashboard Cite

ImportanceClinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis.ObjectiveTo determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis.Design, Setting, and ParticipantsThe Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited.InterventionsStep 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (CBCM) vs SPS; and step 3: 26 weeks of CBCM with fluoxetine vs CBCM with placebo with an embedded fast-fail option of ω-3 fatty acids or low-dose antipsychotic medication. Individuals who did not remit progressed through these steps; those who remitted received SPS or monitoring for up to 12 months.Main Outcomes and MeasuresGlobal Functioning: Social and Role scales (primary outcome), Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Montgomery-Åsberg Depression Rating Scale, quality of life, transition to psychosis, and remission and relapse rates.ResultsThe sample comprised 342 participants (198 female; mean [SD] age, 17.7 [3.1] years). Remission rates, reflecting sustained symptomatic and functional improvement, were 8.5%, 10.3%, and 11.4% at steps 1, 2, and 3, respectively. A total of 27.2% met remission criteria at any step. Relapse rates among those who remitted did not significantly differ between SPS and monitoring (step 1: 65.1% vs 58.3%; step 2: 37.7% vs 47.5%). There was no significant difference in functioning, symptoms, and transition rates between SPS and CBCM and between CBCM with fluoxetine and CBCM with placebo. Twelve-month transition rates to psychosis were 13.5% (entire sample), 3.3% (those who ever remitted), and 17.4% (those with no remission).Conclusions and RelevanceIn this sequential multiple assignment randomized trial, transition rates to psychosis were moderate, and remission rates were lower than expected, partly reflecting the ambitious criteria set and challenges with real-world treatment fidelity and adherence. While all groups showed mild to moderate functional and symptomatic improvement, this was typically short of remission. While further adaptive trials that address these challenges are needed, findings confirm substantial and sustained morbidity and reveal relatively poor responsiveness to existing treatments.Trial RegistrationClinicalTrials.gov Identifier: NCT02751632

show abstract

Section: Discussionmentioning

confidence: 99%

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

McGorry,

Mei,

Amminger

et al. 2023

JAMA Psychiatry

View full text Add to dashboard Cite

show abstract

Mindfulness-Based Cognitive Therapy Self-Assessment Scale (MBCT-SAS)

Prowse

Nagel

Meadows

2022

Handbook of Assessment in Mindfulness Research

View full text Add to dashboard Cite

Assessing the Reliability of the CAMS Rating Scale Using a Generalizability Study

Corona

Gutierrez

Wagner

et al. 2019

Crisis

View full text Add to dashboard Cite

Abstract. Background: An important consideration when conducting randomized controlled trials is treatment differentiation. Direct observation helps ensure that providers in different treatment groups are delivering distinct interventions. One direct observation method is the use of a measure to rate clinician performance when delivering an intervention. Aims: This generalizability study evaluated the reliability of the CAMS Rating Scale (CRS), a measure used to assess delivery of the Collaborative Assessment and Management of Suicidality (CAMS). Method: Digitally recorded tapes of clinicians delivering either CAMS or Enhanced Care-As-Usual (E-CAU) were coded using the CRS. Sessions ( N = 36) were each coded by two raters, and encompassed four clinicians, four time points, and 34 unique patients across two treatment groups. A reliability coefficient (i.e., G coefficient) and the percentages of variance contributed by each component of the measurement model were obtained. Results: The CRS reliably differentiates CAMS from E-CAU, minimizes measurement error relative to expected variance sources, and continues to demonstrate high inter-rater reliability. Limitations: The absence of blind raters, a formal training protocol for the rating team, and ratings from all clinician–patient dyads at all time points was a limitation. Conclusion: The CRS is a reliable treatment differentiation measure that can play an integral role in studies evaluating CAMS.

show abstract

Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review

Cited by 5 publications

References 56 publications

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

Mindfulness-Based Cognitive Therapy Self-Assessment Scale (MBCT-SAS)

Assessing the Reliability of the CAMS Rating Scale Using a Generalizability Study

Contact Info

Product

Resources

About