Evidence map›Paper›PMID 25933919›Full record

Trial reportContemporary clinical trials2015

Maximizing the utility of a single site randomized controlled psychotherapy trial.

Sonya B Norman, Moira Haller, Andrea D Spadoni, Sean P A Drummond, Victoria Risbrough, Jessica L Hamblen, Ryan S Trim, Erika X Blanes

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.4field-weighted citation impact, top 33% of its field
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

8 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Does exposure exacerbate symptoms in veterans with PTSD and alcohol use disorder?Psychological trauma : theory, research, practice and policy · 2021
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  4. Trial
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  6. Article
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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

8 authors at 4 institutions in 2 countries.

Sonya B NormanVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States. Electronic address: snorman@ucsd.edu.
Moira HallerVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: moira.haller@va.gov.
Andrea D SpadoniVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: aspadoni@ucsd.edu.
Sean P A DrummondVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; Monash University, School of Psychological Sciences, Wellington Road, Clayton, VIC 3800, Australia. Electronic address: sean.drummond@monash.edu.
Victoria RisbroughVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: vrisbrough@ucsd.edu.
Jessica L HamblenNational Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States; Geisel School of Medicine at Dartmouth, Department of Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, United States. Electronic address: Jessica.l.hamblen@dartmouth.edu.
Ryan S TrimVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: rstrim@ucsd.edu.
Erika X BlanesVA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: erika.blanes@va.gov.
VA San Diego Healthcare System · USNational Center for Post Traumatic Stress Disorder · USMonash University · AUUniversity of California, San Diego · US

Funding

Role of COMTval158met in PTSD risk and treatment responseI01BX002558 · VA · VA SAN DIEGO HEALTHCARE SYSTEM · PI RISBROUGH, VICTORIA B · 2015 to 2018
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Integrated Alcohol Disorder and PTSD TreatmentI01CX000756 · VA · VA SAN DIEGO HEALTHCARE SYSTEM · PI NORMAN, SONYA · 2013 to 2017
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Neural Mechanisms of a Novel Psychotherapy in Veterans with PTSD and AlcoholismIK2CX000864 · VA · VA SAN DIEGO HEALTHCARE SYSTEM · PI SPADONI TOWNSEND, ANDREA · 2014 to 2018
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BLRD VA I01 BX002558CSRD VA I01 CX000756CSRD VA IK2 CX000864
6 · The paper itself

Abstract

purpose of the researchThere is increasing interest in including measures of biological mechanisms as mediators and moderators of treatment outcome in randomized controlled trials (RCT's) of psychotherapy efficacy. However, examining biological mechanisms is often expensive and budget caps of most major funding agencies have remained stable in recent years. The goal of this manuscript is to describe how a psychotherapy efficacy trial is using a model of collaborative, affiliated grants to maximize resources and the potential knowledge to be gained from a single site RCT. Principal results and conclusions: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans. Through collaboration with a team of investigators with independently-funded but affiliated grants, measures of select sleep, neurobiological, and genetic biomarkers were integrated into this single site RCT. This model has allowed us to pose research questions regarding the role of biological mechanisms, maximize the utility of recruitment, and be efficient in maximizing knowledge to be gained in a way that would not be possible solely on the funding of a single site RCT. Challenges of this model include high participant burden in regard to assessment and complicated coordinating procedures among studies. Strategies to address these challenges are described.

Indexed as

VeteransAdaptation, PsychologicalAlcoholismBiomarkersCatechol O-MethyltransferaseCognitive Behavioral TherapyGenetic Predisposition to DiseaseHumansImplosive TherapyPsychotherapySleepStress Disorders, Post-TraumaticBiomarkersCatechol O-MethyltransferaseCOMT protein, humanBiomarkersPosttraumatic stress disordersRandomized controlled trialTrial methods

Identifiers

PMID25933919
PMCPMC8876249
OpenAlexW1964308211

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.