{"doi":"10.1192/j.eurpsy.2025.10085","title":"The (cost-)effectiveness of exercise therapy adjunct to guideline-concordant care for depression: a pragmatic randomised controlled trial","abstract":"Abstract Background Many patients with major depressive disorder (MDD) do not respond sufficiently to first-line treatments. Due to its biological and psychological mechanisms, exercise may enhance the effectiveness of other MDD treatments. In a pragmatic randomised superiority trial, we evaluated the clinical and cost-effectiveness of exercise therapy adjunct to guideline-concordant care as usual (CAU) for MDD in specialised mental health care. Methods MDD outpatients ( N = 112; Mage = 37; 51% female) were randomized to CAU (96.9% psychotherapy, 59% pharmacotherapy) or CAU + EX (CAU plus 12 weeks of exercise therapy: one supervised and two home-based aerobic sessions/week). Depressive symptoms were assessed using the Inventory of Depressive Symptomatology-Self Report. Remission was evaluated during follow-up by blinded assessors using the Structured Clinical Interview for DSM-5. The economic evaluation followed a societal perspective. Results Patients in the CAU + EX condition were significantly more likely than those in CAU to meet the exercise prescription; however, only 22% fully adhered to it. Depressive symptoms decreased from severe to moderate depression in both conditions, with no significant difference between the conditions on symptom reduction ( b = −0.22, [−0.72, 0.29]) or remission rate (OR = 0.06, [−0.20, 0.32]). Evidence for cost-effectiveness was found in the per-protocol (≥ six supervised exercise sessions) but not in the intention-to-treat sample. Conclusions Adjunct exercise therapy does not provide additional clinical benefits or cost-effectiveness in specialized mental health care. Low adherence to the exercise prescription limits its potential. Cost-effectiveness may be achievable with higher adherence, warranting emphasis on strategies to improve adherence in this population.","journal":"European Psychiatry","year":2025,"id":546036,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9454,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1437289,"name":"Ben Wijnen","orcid":"0000-0001-7993-1905","position":1,"is_corresponding":false},{"id":1437290,"name":"Daan H. M. Creemers","orcid":"0000-0001-8638-8971","position":2,"is_corresponding":false},{"id":1437800,"name":"Alice van Dorp","orcid":null,"position":3,"is_corresponding":false},{"id":1437801,"name":"Peter Oostelbos","orcid":null,"position":4,"is_corresponding":false},{"id":304893,"name":"Indira Tendolkar","orcid":"0000-0003-3171-3671","position":5,"is_corresponding":false},{"id":443309,"name":"Jasper A. J. Smits","orcid":"0000-0003-1633-9693","position":6,"is_corresponding":false},{"id":1437291,"name":"Jan Spijker","orcid":"0000-0003-1480-9647","position":7,"is_corresponding":false},{"id":1168451,"name":"Janna N. Vrijsen","orcid":"0000-0003-0317-6696","position":8,"is_corresponding":false},{"id":1437288,"name":"Michèle Schmitter","orcid":"0000-0002-6664-7187","position":0,"is_corresponding":true}],"reference_count":46,"raw_metadata":null,"created_at":"2026-07-19T02:53:27.751050Z","pmid":"40814823","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}