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This study examines the cost-utility and physiological effects of two psychological treatments, Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD), compared with usual care, in patients with chronic pain and depression. It enrolled people aged 18 to 70 with at least moderate chronic musculoskeletal pain and mild-to-moderate depression. The study was a non-phased study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: Patients who have been visited in the last 3 years in the participating centres and who have been given a diagnosis of chronic non-cancer musculoskeletal pain. In telephone screening, it will be evaluated whether the current pain intensity is at least moderate and PHQ-9 will be administered to confirm the presence of mild to moderate active depression. 1. Patients between 18 and 70 years of age. 2. Diagnosis of chronic pain (≥ 3 months) according to medical history (current pain ≥ 4 out of 10) 3. Diagnosis of mild to moderate depression according to PHQ-9 (score between 5 and 19). 4. Understanding of Spanish. 5. Access to a Smartphone (with Android operating system). 6. Written informed consent. Exclusion Criteria: 1. Presence of cognitive impairment according to MMSE (≤ 24 out of 30). 2. Previous (last year) or current psychological treatment. 3. Presence of severe mental disorder (e.g. psychotic disorder) related to substance dependence/abuse or another disease that affects the CNS (organic brain pathology or head trauma of any severity). 4. Presence of serious, uncontrolled or degenerative medical disease that may interfere with affective symptoms. 5. Risk of suicide (Item 9 score of PHQ-9 ≥ 2). 6. Patients involved in legal proceedings with employers in relation to their illness. 7. Patients with scheduled surgical intervention or other interventions. 8. Inability to attend group treatment sessions. Additional exclusion criteria for the study of biomarkers (50% of subjects in each branch): 1. Cold/infection symptoms on the day of blood collection. 2. Needle phobia. 3. BMI \> 36 kg/m2 or weight \> 110 kg 4. Consumption \> 8 units of caffeine per day (maximum 1 drink with caffeine on the day of testing). 5. Smoker \> 5 cigarettes a day. 6. Being pregnant or breastfeeding