Efficacy of a psychotherapeutic group intervention for patients with Post-COVID-19 condition: a [RCT] (PsyLoCo study), 2026, Rometsch et al.

[Chandelier]

Efficacy of a psychotherapeutic group intervention for patients with Post-COVID-19 condition: a randomized controlled trial (PsyLoCo study)

Spoiler: Authors

Rometsch, Caroline; Colditz, Kimberly; Elgner, Melanie; Allwang, Christine; Zipfel, Stephan; Junne, Florian; Binneböse, Marius

Abstract​

Background​

Persistent physical symptoms such as fatigue following SARS-CoV-2 infection are common and often accompanied by cognitive complaints. Alongside biological mechanisms, psychosocial processes can contribute to symptom persistence.
Psychotherapeutic interventions could be beneficial in symptom reduction.
However, evidence of group-based psychotherapies tailored to Post-COVID-19 condition (PCS) remains limited.

Methods​

In this randomized waitlist-controlled crossover study in an outpatient psychosomatic setting, adults with prior SARS-CoV-2 infection and persisting functionally impairing symptoms were randomized to immediate group psychotherapeutic treatment (intervention group, IG) or treatment as usual with delayed group treatment (control/waitlist group, CG).
The intervention comprised 10 bi-weekly manual-guided group sessions (50 min) covering psychoeducation, somatic symptom processing, emotional regulation, and social reintegration.
Primary outcome was somatic symptom burden (SSS-8). Secondary outcomes were depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7).
Childhood maltreatment (CTS) was examined as a moderator.
Efficacy in the randomized phase was tested using ANCOVA comparing post-treatment outcomes in the IG with post-waiting outcomes in the CG, adjusted for baseline severity.
Three-month follow-up assessments were analyzed descriptively and exploratorily.

Results​

Forty-eight patients were included (IG n = 21; CG n = 27; mean age 53.3 years; 68.8% females). At baseline, somatic symptom burden was high (SSS-8 M = 15.21; SD = 5.62) with clinically relevant depressive symptoms (PHQ-9 M = 10.94, SD = 4.61) and moderate anxiety (GAD-7 M = 7.22; SD = 4.38).
Fatigue-related physical exhaustion and cognitive complaints were the most prominent symptoms.
No significant efficacy of the psychotherapeutic group intervention over TAU was observed for SSS-8 (β = − 2.20, SE = 1.25, 95% CI [− 4.77, 0.38], t(27) = − 1.75, p = .091), PHQ-9 (β = − 1.77, SE = 1.51, 95% CI [− 4.87, 1.33], t(26) = − 1.18, p = .251), or GAD-7 (β = − 0.81, SE = 1.47, 95% CI [− 3.84, 2.22], t(26) = − 0.55, p = .588) comparing post-treatment outcomes in the IG with post-waiting outcomes in the CG.
Baseline symptom severity robustly predicted post-randomization outcomes during the randomized phase (p < .001).
CTS was no moderator for the intervention effect.

Conclusions​

In this exploratory randomized controlled trial, the intervention did not show significant superiority over the control condition; findings should be interpreted cautiously given limited statistical power.
Future psychotherapeutic group interventions for patients with PCS have to consider outcome measures beyond severity of persistent physical symptoms rather than evaluating global symptom scores.
Group-based psychotherapeutic approaches might benefit from flexibility in adaptation for individual patients’ needs.
Stratification by baseline severity and dominant symptom profiles (e.g., fatigue severity, trauma history) may improve sensitivity to clinically meaningful change.

Trial registration​

Trial registration: DRKS German Clinical Trials Register DRKS00040598, registered on 12th June 2026. Retrospectively registered.

Web | DOI | PDF | BMC Psychology

 

[Turtle]

No improvement so we stop evaluating global symptom scores?
Totally bankrupt, but when we count differently we're doing fine.
Psy loco indeed.
That penny needs to be shoved through, it won't drop on it's own in this lot.

 

[Utsikt]

5/21 in the treatment first group dropped out, while 13/27 dropped out in the waitlist group.

They are planning on doing a second publication with the rest of the data.

Further preregistered outcomes (i.e., psychosocial and feasibility-related outcomes) will be published separately due to the extensive scope of the dataset.

Yet they claim that none of the outcomes in this paper were chosen post hoc, even though there is nothing in the protocol about separating out some data from the other data.

No outcome analyses reported here were selectively chosen post hoc.

My guess is that they are either looking to pad their publication stats, or they have found an outcome that was in favour of the intervention and statistically significant, and they want to report that as a success in a separate publication. They did Bonferroni-correction, but I’m not sure if that applies to the whole data set or just the data in this paper.

The protocol also said they would do imputation methods for missing data, yet this publication says it wasn’t done because it was a pilot.

Protocol:

Addressing missing data, imputation methods will be employed to ensure analyses are predicated upon as complete a dataset as possible.

If there is incomplete or missing data, we will use imputation techniques.

Paper:

Given the exploratory pilot character and small sample size, no multiple imputation procedure was applied.

The protocol also says that «exploratory analysis» is «not applicable».

Apparently, there were some blood samples and other physical measurements:

In addition, a physical examination should take place, vital parameters should be measured (pulse, RR) and a blood sample should be taken to measure inflammation parameters (differential blood count, CRP) (by medical doctors with a specialization in psychosomatic medicine).

The DRKS registration that’s listed on the OSF page says they were aiming for 120 participants:

The treatment manual will be piloted and evaluated in this study using a sample of N=120 participants who have recovered from COVID-19. Participants will be randomly assigned to either an intervention group (n=60) or a waitlist control group (n=60). After the intervention group has completed the treatment, the waitlist control group will also receive the treatment.

It also lists the number of recruited participants as 123.

Yet the papers lists another DRKS registration with numbers corresponding to this paper.

The peer review reports include a lot of basic errors they had to correct, including being told to make the wording in the conclusion align with the null result.

 

[Chandelier]

Thank you @Utsikt for this excellent analysis.

They have their own project website:

PsyLoCo – Psychosoziale Bedarfe durch Long-COVID

psyloco.de

Google Translate link.

I might be superstitious but the last German project (CONFIDENCE) that came with its own website had projected costs of € 7.6 millions.
The Loco project website mentions 17 active scientist.
The cost for the whole project must be way over €700‘000 as I can’t find the current study in this project listing.

My guess is that they are either looking to pad their publication stats, or they have found an outcome that was in favour of the intervention and statistically significant, and they want to report that as a success in a separate publication.

The goal of the PsyLoCo project is apparently the creation of a treatment manual.
From their project website:

The aim of the project is to develop a treatment manual that provides information on the most common symptoms and, for each of them, offers treatment recommendations.

The peer review reports include a lot of basic errors they had to correct, including being told to make the wording in the conclusion align with the null result.

I wonder whether having set project goals too high favors such behavior or if this is merely a display of incompetence.

 

[Trish]

Psy loco indeed.
That penny needs to be shoved through, it won't drop on it's own in this lot.

My first thought. Surely this can't be accidental:

Cambridge dictionary:

Loco:
adjective [ after verb ]
mainly US slang
crazy:
go loco Man, he just went loco and smashed the place up.

Spoiler: synonyms

Synonyms
barmy mainly UK informal
batty informal disapproving
bonkers informal humorous
cracked (MENTAL HEALTH)
crackers UK informal
dotty UK informal
kooky mainly US informal
loony informal
loopy informal
nuts informal
nutty (PERSON) informal
wacky informal

 

[Utsikt]

The DRKS registration that’s listed on the OSF page says they were aiming for 120 participants:

Yet the papers lists another DRKS registration with numbers corresponding to this paper.

I think I’ve figured it out.

The former is the protocol for a study with 1:1 sessions.

The latter, and this thread, is about group sessions.

I’m guessing the manual is probably the same for both?

The 1:1 study was done many years ago,

Planned study start date: 2023-03-15
Actual study start date: 2023-03-15
Planned study completion date: 2023-09-30
Actual Study Completion Date: 2023-12-07

And the protocol was published in 2024 after the study was finished.

I’m not able to find any results from that trial, but I’m not confident in my ability to search for German papers.

 

[rvallee]

How does it make sense to talk of doing more studies (as if group setting is meaningful) given the null results? I get that this is just routine in this industry, every single trial concludes that the trial wheel should spin indefinitely, the same way, with the same intent, but it's still absurd every single time. Especially when every single subsequent trial simply ignores all of those recommendations anyway and does it like it's the very first trial of its kind.

What is even the point of research whose results are irrelevant and ignored? Decade after decade of just doing the same garbage without ever caring about whether it even makes any sense. Especially when there isn't even a plausible basis for it in the first place, which they are all obviously aware of considering their extremely hedging language (may be, could be, can be, about a common treatment model used on millions already).

Group-based psychotherapeutic approaches might benefit from flexibility in adaptation for individual patients’ needs.

Group-based, but individualized? Who even writes this stuff? Do they even think about what they write? How come no one involved in the process of reviewing this is bothered by those absurd contradictions? Clearly the substance of the protocol, the intervention or the publications is entirely irrelevant to everyone involved.

And yeah loco means crazy is Spanish. Nice dog whistle. Much coincidence. For sure it totally means place, as in locomotion, because, see, group therapy happens in places. Very legit and convincing.

 

[Chandelier]

I’m not able to find any results from that trial

What a mess.

And the protocol was published in 2024 after the study was finished.

We are talking about this pilot study:

DRKS00030866
Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention

Psychosoziale Bedarfe von Patient*innen mit Long-COVID - Pilotstudie

I‘m not able to find any further mention of a released final study, either.
Even in the protocol the field for planned publication of the study says "no entry".
When following the lead of the main author Allwang, I find that she has written an article that cites this study but apart from that it’s a dead end.

Spoiler: Allwang follow-up article

Long/post-COVID—A complex challenge for psychotherapy Considerations and psychotherapeutic approaches for dealing with this new disease, 2025, Allwang et al.

Long‑/Post-COVID – eine komplexe Herausforderung für die Psychotherapie, 2025, Allwang et al.

Allwang, C.; Frank, T.

Abstract​

Long/post-COVID poses a complex challenge for psychotherapeutic care.
In addition to persistent physical complaints such as fatigue and breathing problems, patients often report cognitive impairment, anxiety and depressive symptoms.
The diagnostic classification is based on the WHO definition and the S1 guidelines for Germany, which describe three main categories of post-COVID symptoms.

The pathomechanism of long/post-COVID has not yet been conclusively clarified.
In addition to biological factors, psychosocial factors also play a role.
Vulnerabilities such as biographical stress and maladaptive illness beliefs can promote the chronification of symptoms.

Psychotherapeutic treatment requires an interdisciplinary, individualized approach.
The Psychosocial needs of patients with long-COVID (PsyLoCo) study developed and evaluated a psychotherapeutic manual that combines cognitive behavioral therapy, psychodynamic approaches and psychoeducation.

Additional therapeutic measures support coping.
Procedures such as acceptance and commitment therapy (ACT), trauma therapy (eye movement desensitization and reprocessing, EMDR), relaxation techniques and pacing strategies have proven to be helpful.
In particular, targeted sensitization to a biopsychosocial perspective can increase the acceptance of therapy and the self- efficacy of those affected.

Web | DOI | PDF | Die Psychotherapie

When looking at which other papers cited this protocol I find papers from the same research group.
One article where it seems as if they just let their wishful thinking fly.

Spoiler: Article

»One cannot not expect«, 2025, Wedekind et al.
»Man kann nicht nicht erwarten«, 2025, Wedekind et al.

Spoiler: Authors

Wedekind, Lisa; Fritzsche, Luzie; Gündel, Harald; Frisch, Stephan

Abstract
»One cannot not expect«. Expectation-focused psychotherapy for post-COVID syndrome
Research shows that relatively little importance has been attached to the psychotherapeutic treatment of patients with post-COVID syndrome (PCS).
However, integrative causal models of the development of PCS and the frequent presence of psychological comorbidities in the disease show the potential for psychosomatic-psychotherapeutic treatment options.
In addition to the biopsychosocial disease model, the vulnerability-stress model of persistent or functional physical complaints and the neurobiologically-based theory of »predictive coding« are discussed as concepts for a deeper understanding of the disorder.
Whether »expectation modification« as a psychotherapeutic focus in PCS can be derived from previous models and comparable intervention studies is also investigated.
The current state of research on this subject relies on a small number of studies to date, but a large number of studies are currently being conducted or prepared.
Expectation-focused psychotherapy appears to be a promising mechanism for PCS.

Web | DOI | Ärztliche Psychotherapie

Finally an actual study citing the pilot:
How to cope with Long COVID – A qualitative interview study on stressors and coping strategies of people affected by [LC], 2026, Elgner et al.

And another study protocol:
Effectiveness of two interventions to optimize expectations in psychosomatic rehabilitation of post-COVID patients: study protocol for an integrative approach, 2026 Wedekind et al.

This is the manual. Unfortunately behind a paywall:
Psychosocial aspects of Long COVID – A psychotherapeutic treatment manual from the PsyLoCo project, 2025, Frank et al.

 

[Peter T]

My first thought in relation to the word ‘loco’ is a shortened form of steam locomotive, ie the engine pulling a train.

 

[Hutan]

Noting the institutions involved:

Tuebingen, Germany

• Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tuebingen, Osianderstr.5, Tübingen,
• German Center for Mental Health (DZPG), Partner Site Tübingen, Berlin

Magdeburg

• Medical Faculty, University Clinic for Psychosomatic Medicine and Psychotherapy, University Medicine, Otto-Von-Guericke-University Magdeburg, Leipziger Str. 44, Magdeburg
• German Center for Mental Health (DZPG), Partner Site Halle-Jena-Magdeburg, Magdeburg
• Center for Behavioral Brain Sciences (CBBS), Magdeburg, Germany

Munich

• TUM School of Medicine and Health, Technical University of Munich, Ismaninger Str. 22, 81675, Munich, Germany

It's not the first time we have seen Long Covid shortened to LoCo in a BPS study. I think, if anyone had the time, it would be worth writing to the institutions involved to complain about their staff members being involved in a study that displayed such disregard for the patient community to call a study PsyLoCo. Even for mental health studies, that surely has to be seen as unacceptable.

On the positive side, it appears that BMC Psychology has done a decent job, ensuring that the results are presented reasonably accurately. Every null result that gets reported as such is a win, making it harder for more of this stuff to be justified.

Future psychotherapeutic group interventions for patients with PCS have to consider outcome measures beyond severity of persistent physical symptoms rather than evaluating global symptom scores.

It might be that, rather than trying to change the disease, psychotherapy could focus on helping people cope. (But, they just don't seem to be able to stop themselves from delving into childhood trauma.)

 

[Hutan]

From the Allwang followup article that Chandelier linked:

Procedures such as acceptance and commitment therapy (ACT), trauma therapy (eye movement desensitization and reprocessing, EMDR), relaxation techniques and pacing strategies have proven to be helpful.
In particular, targeted sensitization to a biopsychosocial perspective can increase the acceptance of therapy and the self- efficacy of those affected.

"Targeted sensitisation to a biopsychosocial perspective can increase the acceptance of therapy"
Wow. That reads like 'pick off the vulnerable who might actually believe this stuff'.

 

[Hutan]

My first thought in relation to the word ‘loco’ is a shortened form of steam locomotive, ie the engine pulling a train.

My first thought when I hear 'loco' is definitely 'crazy'. I'm not sure if that was too much exposure to Speedy Gonzales cartoons as a child, but it's definitely widely understood as crazy in my part of the world, even if it is not used very much as such. And, of course, anyone with exposure to the Spanish language would recognise it.

 

[Hutan]

Research shows that relatively little importance has been attached to the psychotherapeutic treatment of patients with post-COVID syndrome (PCS).
However, integrative causal models of the development of PCS and the frequent presence of psychological comorbidities in the disease show the potential for psychosomatic-psychotherapeutic treatment options.

The current state of research on this subject relies on a small number of studies to date, but a large number of studies are currently being conducted or prepared.
Expectation-focused psychotherapy appears to be a promising mechanism for PCS.

This from the second article Chandelier has in a spoiler upthread. So, more dross coming. We need Long Covid charities to publicise this and other null results, to make it harder for these psychosomatic promoters to harm the psyches of people desperate for help.

 

[Utsikt]

On the positive side, it appears that BMC Psychology has done a decent job, ensuring that the results are presented reasonably accurately. Every null result that gets reported as such is a win, making it harder for more of this stuff to be justified.

That was all down to the peer reviewers.

Although they did also say that they shouldn’t make too strong statements about how this doesn’t definitively prove that the intervention isn’t effective, as if that’s a realistic option. False negatives in this field are unicorns.

 

[Chandelier]

It's not the first time we have seen Long Covid shortened to LoCo in a BPS study.

That penny needs to be shoved through, it won't drop on it's own in this lot.

I must admit, I was really confused about the capitalization used in LoCo.
Thanks for the shoving effort, Hutan, it finally clicked!

I think, if anyone had the time, it would be worth writing to the institutions involved to complain about their staff members being involved in a study that displayed such disregard for the patient community to call a study PsyLoCo. Even for mental health studies, that surely has to be seen as unacceptable.

What an embarrassing disgrace!
How did this pass the funding stage?

My first thought when I hear 'loco' is definitely 'crazy'. I'm not sure if that was too much exposure to Speedy Gonzales cartoons as a child

They should at least think about a brand refresh, something more modern and with a lot more verve.
How about: LoCo-LoCo-AI-AI-AI

 

[Hutan]

Ah, or a new title for their psychotherapy sessions 'STOP! Livin' La Vida LoCo'

 

[Sean]

What is even the point of research whose results are irrelevant and ignored? Decade after decade of just doing the same garbage without ever caring about whether it even makes any sense. Especially when there isn't even a plausible basis for it in the first place, which they are all obviously aware of considering their extremely hedging language (may be, could be, can be, about a common treatment model used on millions already).

Rarely in human history do you see such a solid track record of comprehensive, unrelenting, and dishonest failure get so rewarded and protected.

"Targeted sensitisation to a biopsychosocial perspective can increase the acceptance of therapy"
Wow. That reads like 'pick off the vulnerable who might actually believe this stuff'.

Even worse, those patients who know it is bullshit, but simply do not have the capacity to keep objecting and fighting back, and are just superficially agreeing in order to get these clowns off their already heavily burdened backs, at least a little.

It never ceases to stun me how the very profession charged with understanding these kind of pathological factors seem so utterly blind to them when they are the cause of them. It is extraordinarily cruel and dishonest nonsense. A very disturbing kind of wilful blindness and failure of basic self-awareness and human decency.

 

[Chandelier]

From @NichtGenesen on Twitter.

Machine Translation:

---

The PsyLoCo study is NOT evidence of therapeutic success, but rather a safety warning signal!​

Following group therapy, the average scores for physical complaints WORSENED in the immediately treated group.​

The waitlist group performed better in all three immediate comparisons.​

When the waitlist group subsequently received the same treatment, physical symptom burden also increased in that group, rising from 14.21 to 16.17.​

Not a single efficacy endpoint examined demonstrated a proven benefit.​

At the same time, potential harms were assessed only unsystematically.​

A therapy that shows no demonstrated benefit, whose results trend toward deterioration, and whose risks were not properly investigated must not be marketed as either effective or safe!!!​

---

 

[rvallee]

A therapy that shows no demonstrated benefit, whose results trend toward deterioration, and whose risks were not properly investigated must not be marketed as either effective or safe!!!

That's a description of non-pharmaceutical evidence-based medicine. To them that's a win. It's a product that sells like hot cakes. For the same reason the alternative medicine industry is so effective, at getting people to spend money on alternative medicine. Except without the need to even go looking for clients, so they have an even easier time at it.

Why bother make any effort at all when not trying is the best formula for success? All they have to do is redefine success, and they've solved nothing but whatever it's an easy bullshit job that can be sleep-walked every day, and occasionally get applauded by their peers for their success in not doing anything.