Cost-utility and Physiological Effects of ACT and BATD in Patients With Chronic Pain and Depression (IMPACT)
Randomized Controlled Trial
About this trial
This is an interventional treatment trial for Randomized Controlled Trial
Eligibility Criteria
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.
- Patients between 18 and 70 years of age.
- Diagnosis of chronic pain (≥ 3 months) according to medical history (current pain ≥ 4 out of 10)
- Diagnosis of mild to moderate depression according to PHQ-9 (score between 5 and 19).
- Understanding of Spanish.
- Access to a Smartphone (with Android operating system).
- Written informed consent.
Exclusion Criteria:
- Presence of cognitive impairment according to MMSE (≤ 24 out of 30).
- Previous (last year) or current psychological treatment.
- 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).
- Presence of serious, uncontrolled or degenerative medical disease that may interfere with affective symptoms.
- Risk of suicide (Item 9 score of PHQ-9 ≥ 2).
- Patients involved in legal proceedings with employers in relation to their illness.
- Patients with scheduled surgical intervention or other interventions.
- Inability to attend group treatment sessions.
Additional exclusion criteria for the study of biomarkers (50% of subjects in each branch):
- Cold/infection symptoms on the day of blood collection.
- Needle phobia.
- BMI > 36 kg/m2 or weight > 110 kg
- Consumption > 8 units of caffeine per day (maximum 1 drink with caffeine on the day of testing).
- Smoker > 5 cigarettes a day.
- Being pregnant or breastfeeding
Sites / Locations
- Parc Sanitari Sant Joan de Déu (PSSJD)
- Parc de Salut Mar
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
TAU + Acceptance and Commitment Therapy (ACT)
TAU + Behavioral Activation Therapy for Depression (BATD)
Treatment as Usual (TAU)
This therapy is based, as the name implies, on the acceptance (not avoidance) of negative experiences as a coping strategy, and on committing to life values or objectives. ACT has been used for various conditions, including chronic pain. Since avoidance is a strategy frequently used by patients suffering from pain, the application of this therapy seems very appropriate. In fact, it has been proven that patients who accept their pain more are those who score lower in pain intensity, have less negative emotions and enjoy a better quality of life.
Behavioural and structured treatment based on the application of learning principles. Its objective is to counteract depressive symptoms and, as a consequence, to ensure that patients regain a productive and emotionally satisfying life. Its basic methodology consists in activating subjects with depression through programming and conduct of behaviours that are likely to increase the positive reinforcement of their context.
Standard Care. Although there is no treatment considered as the gold standard for chronic pain and comorbid major depression, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient.