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Lost to follow-up

October 30, 2013

2/3 participants in a research trial on postnatal depression

This randomised trial of internet-based behavioural activation (i-BA), to treat postnatal depression had some unusual design features. Participants were identified via a parenting website, Netmums, and gave consent, established eligibility and were randomised online.  Those who scored 12 or more on the Edinburgh Postnatal Depression Score (EPDS) were allocated at random as follows:

Experimental – Eleven 40-minute sessions of i-BA delivered online over a period of up to 15 weeks, with access to an i-BA specific online chat room,

Control – Treatment as usual, which consisted of access to Netmums general depression chat rooms.

Of 910 participants 464 were allocated to i-BA, and 448 to treatment as usual but, despite reminders, only 181 (39%) of the i-BA group and 162 (36%) of the TAU group completed the primary outcome of EPDS at 15 weeks. Among this group the mean depression score was lower (11 v 14) in the intervention group.  The trial was published in J Affective Disorders in October (click here Note added 30/10/2013 – the original link was to another NETMUMs trial by the same authors. Corrected 20.44 GMT) and the university of Exeter has been tweeting about it.

The trial was unregistered, so we have to take on trust that the sample size and primary endpoints were predetermined.  More important are the high losses to follow-up. What happened to them? Although participants were asked to provide their GP contact details, we are not told either how many did so, or whether any experienced major harms. In any normal depression trial, of drug treatment let us say, the authors would report suicide attempts and hospital admissions.

The study was approved by the University of Exeter’s research ethics committee, which is not part of the NHS research ethics committee network.  It was supported by the National institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research (CLAHRC), who should know better.

This is the second time recently that the University of Exeter has trumpeted the success of their well-meaning but shambolic research (click here).

Jim Thornton

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3 Comments leave one →
  1. pureform 2000 permalink
    October 30, 2013 4:37 pm

    Heres why women are generally less happy nowadays.

    Not just from post-natal depression.

    Its a very interesting theory.

    Thoughts.?

    Lawrence.

    Date: Wed, 30 Oct 2013 07:53:35 +0000 To: pureform2000@hotmail.com

  2. October 30, 2013 4:54 pm

    We are seeing increasing number of announcements in mainstream media as ‘ground breaking research’, especially closer to the REF deadline. Someone needs to inform the University press offices that media impact does not count towards REF..

  3. October 30, 2013 5:21 pm

    The way to end post-partum depression is to stop interfering with the normal birth process. Technical advances have left the USA 47th in the world for infant outcome (survivors of birth) and 50th in the world for mother outcome (survivors of birth). That means 47 and 50 countries, including African nations, have a better outcome for mothers and babies than the USA does. When normal birth occurs in the same bed the baby was conceived, with mother, making the same sounds they did during conception, and then holding and sleeping with their babies in the days and weeks that follow, mothers will not be depressed after one of the most profound moments of their life!

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