Evidence mapPaperPMID 39780444Full record

Trial reportInternational journal of methods in psychiatric research2025

Statistical methods to adjust for the effects on intervention compliance in randomized clinical trials where precision treatment rules are being developed.

Nur Hani Zainal, Corina Benjet, Yesica Albor, Mauricio Nuñez-Delgado, Renato Zambrano-Cruz, Carlos C Contreras-Ibáñez, Lorena Cudris-Torres, Francisco R de la Peña, Noé González, José Benjamín Guerrero-López and 13 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of methods in psychiatric research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Nur Hani ZainalDepartment of Psychology, National University of Singapore, Singapore, Singapore.
Corina BenjetCenter for Global Mental Health, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.ORCID 0000-0002-4569-6094
Yesica AlborCenter for Global Mental Health, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.
Mauricio Nuñez-DelgadoDepartamento de Psicología, Universidad Popular de Cesar, Valledupar, Colombia.
Renato Zambrano-CruzUniversidad Cooperativa de Colombia, Medellin, Colombia.
Carlos C Contreras-IbáñezDepartamento de Sociología, Universidad Autónoma Metropolitana, Mexico City, Mexico.
Lorena Cudris-TorresPrograma de Psicología, Fundación Universitaria del Area Andina, Valledupar, Colombia.
Francisco R de la PeñaUnidad de Fomento a la Investigacion, Direccion de Servicios Clínicos, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.ORCID 0000-0001-5421-2744
Noé GonzálezCenter for Global Mental Health, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.
José Benjamín Guerrero-LópezDepartamento de Psiquiatría y Salud Mental, Universidad Nacional Autónoma de México, Mexico City, Mexico.
Raúl A Gutierrez-GarciaFacultad de Estudios Superiores, Universidad De La Salle Bajío, Salamanca, Guanajuato, Mexico.
Ana Lucía Jiménez-PerézFacultad de Ciencias Administrativas y Sociales, Universidad Autónoma de Baja California, Ensenada, Mexico.
Maria Elena Medina-MoraCenter for Global Mental Health, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.
Pamela PatiñoCenter for Global Mental Health, National Institute of Psychiatry Ramón de la Fuente Muñiz, Mexico City, Mexico.
Pim CuijpersDepartment of Clinical, Neuro-, and Developmental Psychology, Vrije Universiteit, Amsterdam, The Netherlands.ORCID 0000-0001-5497-2743
Sarah M GildeaDepartment of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.
Alan E KazdinDepartment of Psychology, Yale University, New Haven, Connecticut, USA.
Chris J KennedyDepartment of Psychiatry, Center for Precision Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
Alex LuedtkeDepartment of Statistics, University of Washington, Seattle, Washington, USA.
Nancy A SampsonDepartment of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.
Maria V PetukhovaDepartment of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.
Jose R ZubizarretaDepartment of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.
Ronald C KesslerDepartment of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0003-4831-2305

Funding

FIC NIH HHS R01MH120648NIMH NIH HHS R01 MH120648NIMH NIH HHS R01MH120648
6 · The paper itself

Abstract

backgroundHeterogeneity of treatment effects (HTEs) can occur because of either differential treatment compliance or differential treatment effectiveness. This distinction is important, as it has action implications, but it is unclear how to distinguish these two possibilities statistically in precision treatment analysis given that compliance is not observed until after randomization. We review available statistical methods and illustrate a recommended method in secondary analysis in a trial focused on HTE.

methodsThe trial randomized n = 880 anxious and/or depressed university students to guided internet-delivered cognitive behavioral therapy (i-CBT) or treatment-as-usual (TAU) and evaluated joint remission. Previously reported analyses documented superiority of i-CBT but significant HTE. In the reanalysis reported here, we used baseline (i.e., pre-randomization) covariates to predict compliance among participants randomized to guided i-CBT, generated a cross-validated within-person expected compliance score based on this model in both intervention groups, and then used this expected composite score as a predictor in an expanded HTE analysis.

resultsThe significant intervention effect was limited to participants with high expected compliance. Residual HTE was nonsignificant.

conclusionsFuture psychotherapy HTE trials should routinely develop and include expected compliance composite scores to distinguish the effects of differential treatment compliance from the effects of differential treatment effectiveness.

Indexed as

Cognitive Behavioral TherapyAdultAnxiety DisordersData Interpretation, StatisticalFemaleHumansMaleOutcome Assessment, Health CarePatient ComplianceRandomized Controlled Trials as TopicYoung Adultcompliance average causal effectheterogeneity of treatment effectsinternet‐delivered cognitive behavioral therapyprecision medicinerandomized controlled trial

Identifiers

PMID39780444
PMCPMC11711205

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.