Evidence map›Paper›PMID 35668483›Full record

ArticlePilot and feasibility studies2022

The design and evaluation of a health education control for comparison with cognitive behavioural therapy for individuals with acquired brain injury.

Lucy Ymer, Adam McKay, Dana Wong, Jennie Ponsford

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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 at 2 institutions in 1 country.

Lucy YmerSchool of Psychological Sciences, Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia. lucy.ymer1@monash.edu.ORCID http://orcid.org/0000-0002-6114-6199
Adam McKaySchool of Psychological Sciences, Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.
Dana WongSchool of Psychological Sciences, Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.
Jennie PonsfordSchool of Psychological Sciences, Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.
Epworth Hospital · AULa Trobe University · AU

Funding

National Health and Medical Research Council APP1023043National Health and Medical Research Council APP1174473
6 · The paper itself

Abstract

backgroundIn psychological research, control conditions in the form of "treatment as usual" provide support for intervention efficacy, but do not allow the attribution of positive outcomes to the unique components of the treatment itself. Attentionally and structurally equivalent active control conditions, such as health education (HE), have been implemented in recent trials of cognitive behavioural therapy (CBT). However, descriptions and evaluations of these control conditions are limited. The aims of this paper were to (i) provide a detailed description and rationale for a novel HE active control condition and (ii) to evaluate the face validity, treatment integrity and feasibility of HE.

methodWe developed a HE active control similar in structure and duration to a CBT intervention for reducing sleep disturbance and fatigue (CBT-SF) in a pilot randomised controlled trial (n = 51). Face validity was measured using post-treatment participant satisfaction and helpfulness ratings for fatigue and sleep symptoms, treatment fidelity was measured with integrity monitoring ratings from an independent expert and feasibility was measured with completion and attrition rates. HE and CBT-SF groups were compared using Wilcoxon rank-sum tests and chi-square tests of independence.

resultsThere were no significant differences in participant ratings of overall satisfaction between HE (n = 17) and CBT (n = 34) or in how helpful each intervention was for fatigue symptoms. Participants rated helpfulness for sleep symptoms higher in the CBT-SF group compared to HE. Integrity monitoring ratings were not significantly different for overall treatment delivery and therapist competency, but HE had greater module adherence than CBT-SF. There were no significant differences in completion or attrition rates between groups.

conclusionOur findings suggest that the HE control had adequate face validity, was delivered with fidelity and was feasible and suitable for use as a comparator for CBT-SF. In providing a real-world example of practical and theoretical issues we considered when designing this control condition, we aim to provide a framework and guidance for future investigators.

trial registrationACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017).

Indexed as

Acquired brain injuryCognitive behavioural therapyControl conditionFatigueHealth educationSleep

Identifiers

PMID35668483
PMCPMC9169288
OpenAlexW4281652530

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.