Preliminary clinical and cost effectiveness of augmented depression therapy versus [CBT] for the treatment of anhedonic depression, 2023, Price et al

Preliminary clinical and cost effectiveness of augmented depression therapy versus cognitive behavioural therapy for the treatment of anhedonic depression (ADepT): a single-centre, open-label, parallel-group, pilot, randomised, controlled trial
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00261-4/fulltext
Open Access:July 13, 2023


Background
Anhedonia (reduced interest/pleasure) symptoms and wellbeing deficits are core to depression and predict a poor prognosis. Current depression psychotherapies fail to target these features adequately, contributing to sub-optimal outcomes. Augmented Depression Therapy (ADepT) has been developed to target anhedonia and wellbeing. We aimed to establish clinical and economic proof of concept for ADepT and to examine feasibility of a future definitive trial comparing ADepT to Cognitive Behavioural Therapy (CBT).

Methods
In this single-centre, open-label, parallel-group, pilot randomised controlled trial, adults meeting diagnostic criteria for a current major depressive episode, scoring ≥10 on the Patient Health Questionnaire (PHQ-9) and exhibiting anhedonic features (PHQ-9 item 1 ≥ 2) were recruited primarily from high intensity Improving Access to Psychological Therapy (IAPT) service waiting lists in Devon, UK. Participants were randomised to receive 20 sessions of CBT or ADepT, using a mimimisation algorithm to balance depression severity and antidepressant use between groups. Treatment was delivered in an out-patient university-based specialist mood disorder clinic. Researcher-blinded assessments were completed at intake and six, 12, and 18 months. Co-primary outcomes were depression (PHQ-9) and wellbeing (Warwick Edinburgh Mental Wellbeing Scale) at 6 months. Primary clinical proof-of-concept analyses were intention to treat. Feasibility (including safety) and health economic analyses used complete case data. This trial is registered at the ISRCTN registry, ISRCTN85278228.

Findings
Between 3/29/2017 and 7/31/2018, 82 individuals were recruited (102% of target sample) and 41 individuals were allocated to each arm. A minimum adequate treatment dose was completed by 36/41 (88%) of CBT and 35/41 (85%) of ADepT participants. There were two serious adverse events in each arm (primarily suicide attempts; none of which were judged to be trial- or treatment-related), with no other evidence of harms. Intake and six-month primary outcome data was available for 37/41 (90%) CBT participants and 32/41 (78%) ADepT participants. Between-group effects favoured ADepT over CBT for depression (meanΔ = −1.35, 95% CI = −3.70, 1.00, d = 0.23) and wellbeing (meanΔ = 2.64, 95% CI = −1.71, 6.99, d = 0.27). At 18 months, the advantage of ADepT over CBT was preserved and ADepT had a >80% probability of cost-effectiveness.

Interpretation
These findings provide proof of concept for ADepT and warrant continuation to definitive trial.

 

For a preliminary open label trial, this is a very long paper, with a cost-effectiveness analysis, that concludes going from small preliminary trial to definitive trial in one jump.

This pragmatic trial compares a new psychotherapy with CBT, so isn't actually controlled. Or I guess it's sham-controlled. It seems to be based around the idea of cheering the patients up, making them look on the bright side of life. Which no one had ever thought of before. And certainly is not part of current depression-focused CBT. Obviously.

They seem to write that the "gold standard" of depression-focused CBT is not optimized for depression, probably on account of very poor results that come from dubious, open label trials without adequate controls. It's basically CBT with some slightly different context. It boasts of requiring only minimal training from CBT therapists.

Primary outcome were the PHQ-9 and Warwick edinburgh mental wellbeing scale (WEMWBS). Differences appear minimal.

I have no idea how this is supposed to be different than how they describe their "new" therapy, or why this isn't "optimized" for depression:

I guess you could call those different, if you want.

I don't know how those numbers add up (they don't):

TL;DR: people paid to do clinical trials want more money to do more clinical trials for this distinct-but-not-different-"novel"-thingy.

 

How I saw it covered in media: Scientists Unveil Cheaper and More Effective Depression Treatment.

A promising new therapeutic approach for depression appears to be more cost-effective and potentially more effective than the existing gold standard of Cognitive Behavioural Therapy (CBT).
...
If these findings can be replicated in a subsequent definitive trial, it would suggest that ADepT can have both clinical and economic benefits in healthcare settings. ADepT has also been designed so that existing CBT therapists will be able to deliver it with minimal additional training.​

 

Sessions are noted as " up to X number "
A " minimum adequate treatment dose was completed by X number"
Do these session numbers and treatment doses correlate ?
A booster session sounds good - is this follow up making the difference ( rather than simply being spat out if the sausage making CBT machine)?
Would booster session CBT have had the same effect - who knows it wasn't done.

How are harms defined ?
CBT is never seemingly associated with harm's and yet , anecdotally from some having experienced it, it can be what most would term harmful.
Bit like those anti depressants handed out like sweeties that don't have side effects ......