Evidence map›Paper›PMID 26628268›Full record

Trial reportTrials2015

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial.

Adrian R Allen, Jill M Newby, Jessica Smith, Gavin Andrews

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 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.

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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  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

4 authors.

Adrian R AllenClinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. adrian.allen@unsw.edu.au.
Jill M NewbyClinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. j.newby@unsw.edu.au.
Jessica SmithClinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. Jessica.smith@svha.org.au.
Gavin AndrewsClinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St Vincent's Hospital, Level 4, O'Brien Centre, St. Vincent's Hospital, 394-404 Victoria Street, Darlinghurst, NSW, Australia. gavina@unsw.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. METHODS/

designPatients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to a treatment group or waitlist control group. The minimum sample size for each group (alpha 0.05, power 0.80 for a g of 0.47) was identified as 72, but 10 % more will be recruited to hedge against expected attrition. PTSD diagnosis will be determined using the PTSD module from the Mini International Neuropsychiatric Interview version 5.0.0. The PTSD Checklist - Civilian version (PCL-C) will be used to measure PTSD symptoms (the primary outcome measure), with the Intolerance of Uncertainty Scale 12-item version (IUS-12) and the Emotion Regulation Questionnaire (ERQ) used to measure intolerance of uncertainty and emotion regulation, respectively. The PCL-C will be administered to the treatment group before each lesson of the PTSD program and at 3-month follow-up. The IUS-12 and ERQ will be administered before lessons 1 and 4, at post-treatment and at 3-month follow-up. The waitlist control group will complete these measures at week 1, week 5 and week 11 of the waitlist period. PTSD program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at 3-month follow-up. Mediation analyses using PROCESS will be used to examine the association between change in PTSD symptoms over treatment and change in each of IU and emotion regulation ability in separate analyses. DISCUSSION: The current RCT seeks to replicate previous efficacy findings of iCBT for PTSD in a formally assessed PTSD sample from the general population. Findings may point to future lines of enquiry for the role of IU and emotion regulation in the mechanism of PTSD symptom change during CBT.

trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12614001213639 , registered 18 November 2014. This trial protocol is written in compliance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Indexed as

Cognitive Behavioral TherapyInternetAustraliaChecklistClinical ProtocolsCognitionEmotionsHumansIntention to Treat AnalysisPsychiatric Status Rating ScalesResearch DesignStress Disorders, Post-TraumaticSurveys and QuestionnairesTherapy, Computer-AssistedTreatment OutcomeUncertainty

Identifiers

PMID26628268
PMCPMC4666048

What OpenQuestion holds

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Registered trials

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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.