Summary
Cognitive Behavioral Therapy is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. ClinicalTrials.gov lists 1 registered trial linking Cognitive Behavioral Therapy to ME/CFS: 1 has completed. The most advanced is Phase 1 (NCT00540254, sponsored by Duke University). It plans or enrolled 24 participants. Registered activity dates to 2007. No published literature item is linked to Cognitive Behavioral Therapy and ME/CFS in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome is tracked on the OSMF post-viral programme alongside ME/CFS, Long COVID, POTS and MCAS. Across the programme, 191 candidate agents are logged for ME/CFS, most of them preliminary; this page isolates the record for one of them.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 8.0 (trials 3.0, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 0 |
| Agent type | Other (Other / Unclassified) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Neurological / Autonomic |
| Data sources | OSMF therapeutic agent database, ClinicalTrials.gov |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00540254 | Behavioral Insomnia Therapy With Chronic Fatigue Syndrome Duke University · 2007 | completed | Phase 1 | 24 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Neurological / Autonomic.
Clinical notes: Investigational for listed conditions. 1 associated trial(s) and 0 study reference(s) in current data. Review primary sources and consult specialists before use.
Safety: Limited specific safety data in these populations. Review full prescribing information and consult specialist. Many agents used off-label or investigational.
Dosing in studies: See linked studies/trials for reported doses and durations; typical protocols vary widely.
Frequently asked questions
Is Cognitive Behavioral Therapy approved for ME/CFS?
Cognitive Behavioral Therapy is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cognitive Behavioral Therapy in clinical trials for ME/CFS?
ClinicalTrials.gov lists 1 registered trial linking Cognitive Behavioral Therapy to ME/CFS: 1 has completed. The most advanced is Phase 1 (NCT00540254, sponsored by Duke University). It plans or enrolled 24 participants. Registered activity dates to 2007.
What does the evidence show for Cognitive Behavioral Therapy in ME/CFS?
Cognitive Behavioral Therapy has 1 completed registered trial for ME/CFS but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is C (Preliminary), taken from the OSMF therapeutic agent database, which grades agents by the volume and design of condition-specific evidence rather than by effect size.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-10-07. Page built 2026-10-07.