Dissertation Poster Script

Background of study

Depression is the leading cause of disability worldwide, yet treatments have stagnated.

The current first line treatment for depression is cognitive  behavioural therapy or CBT, which  targets cognition, specifically negative thought patterns. But, it is not effective for all, only around 40% achieve remission after starting with CBT treatment.

This suggests a gap in current treatments, so novel interventions targeting cognition are being developed to address this.

An area of promise involves addressing cognitive biases, which are alterations in interpreting and processing ambiguous information leading to errors. 

In particular,  cognitive bias modification for errors, which targets a range of errors caused by cognitive biases has shown promise.  Yet it has been previously limited to a single in-persons session , which can be a barrier for depressed individuals.

Therefore, the current study has adapted CBM-errors to a remote six session procedure for depression called CURED. Or cognitive bias modification utilised to rectify errors in depression.

Aims and objectives of study

So, what are we aiming to do in this study?

Because this is a feasibility study, we are not testing hypotheses at this stage.

Instead this study has three main aims/ objectives

Firstly to test if this new procedure is feasible. Meaning do participants willingly join, take part and complete the whole trial and follow up.

 

Secondly, is this new procedure safe? Meaning, is the content used safe for depressed individuals , not causing adverse events or worsening of symptoms.

 

Thirdly, to provide variance estimates to inform an efficacy trial. So what key outcomes to use, calculating the power and sample size needed.

Methods of study

Now, how do we plan to carry out this new procedure?

We have planned a double blind randomised controlled trial, involving 60 participants over the course of 1 year.

We plan to screen and recruit eligible participants with major depressive disorder,

 

They will complete the consent form and baseline measures and then be randomised into one of two conditions- CURED or control

Each participant will be posted a pack of 6 booklets to work through once a week.

The booklets contain 40 scenarios made up of three sentences (as shown here)

With the last sentence ending with a fragmented word. The last word is to be filled in with the answer "worthwhile" and shown on the next page for corrections in interpretation.

This is followed by a comprehension question to check the participants actually read the scenario. Then an imagery activity to further enforce positive affect towards interpreting the scenario.

The control scenarios will use neutral or factual scenarios rather than ambiguous ones.

 

After each session/booklet completed, the participant will  complete a post session questionnaire.

They will also receive check in calls at weeks 3 and 6 of the intervention , and at the follow up 6 weeks after their last session, where they will be debriefed.

Analysis plan for study

We plan to analyse by the aims:

Firstly , for feasibility ,we will look at descriptive statistics  as this includes multiple measures .

 

This will also be done for safety, mainly looking at adverse events.

 

For Variance estimates we will use a mixed model ANOVA to provide f statistics of variances.

This will also inform key outcomes for the following study based on significance.

Conclusions of study

This will be the first study to test a new longitudinal protocol of CBM-errors, specifically for depression in a remote, accessible format. It will also include a representative sample, including individuals with comorbid anxiety, which could enable us to clarify feasibility in the presence of comorbidity .

 

However, there are still limitations. This study's is not testing hypothesis , so it cannot conclude efficacy based on the results of this trial. Also, a lack of complete stratifiers for randomisation present challenges, however this is not the main focus of this feasibility trial.

 

 

In the case that CURED is found to be feasible and safe, a full scale digitalised efficacy trial will be conducted.  If these future findings support CURED, this could present opportunities for alternative treatments, as well as providing options to personalise mental health care.

 

Thank you