The goal of this clinical trial is to evaluate whether a combined approach including therapeutic exercise, psychotherapy, and therapeutic education can improve depressive symptoms and quality of life in adults diagnosed with depression.
The main questions it aims to answer are:
Does a biobehavioral intervention that integrates exercise, psychotherapy, and education reduce depressive symptoms more effectively than psychotherapy alone? Does this combined approach improve quality of life, physical function, and sleep quality compared with standard psychological therapy? Researchers will compare the intervention group (therapeutic exercise + psychotherapy + education) to the control group (psychotherapy alone) to determine whether the integrated program provides greater improvements in mental health and well-being.
Participants will:
Complete an initial assessment including demographic data, physical tests, and validated questionnaires.
Be randomly assigned to one of the two groups. If in the intervention group, take part in an 8-week telematic program consisting of graded activity, therapeutic exercise, and educational sessions.
Undergo post-intervention assessments and a follow-up evaluation 12 weeks after the program ends.
This study aims to provide evidence on whether combining therapeutic exercise and education with psychotherapy can enhance treatment outcomes and promote long-term adherence to physical activity in people with depression.
Diagnosis of depression or dysthymia according to the ICD-11 criteria (including unspecified depressive disorder, code 6A7Z) or DSM-5-TR criteria confirmed by their referring physician.
A patient currently undergoing psychological treatment for depression with a score above the established cutoff in a validated depression questionnaire.
Pregnancy.
Presence of neurological comorbidities or neurological signs.
Systemic rheumatic diseases, including fibromyalgia.
Central nervous system disorders.
Parallel
Psychotherapy
BehavioralConventional psychotherapy for depression, including Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy, Interpersonal Therapy, and Mindfulness-Based Cognitive Therapy.
Graded activity combined with exercise and education
BehavioralThis intervention consists of a graded activity program combined with exercise and therapeutic education in motor behavior to improve physical activity levels, self-efficacy and mood
Depressive symptoms
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. This is a self-administered questionnaire with nine items scored on a four-point Likert scale (0-3). Higher scores indicate greater severity.
Quality of life
The World Health Organization Quality of Life Questionnaire (WHOQoL-BREF) is a self-administered instrument validated in Spanish that assesses perceived quality of life across different domains. It consists of 26 items rated on a 5-point Likert scale, yielding a total score and four domain scores: physical health, psychological health, social relationships, and environment. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life
Physical activity levels
The Global Physical Activity Questionnaire (GPAQ) is a self-administered instrument that assesses physical activity across three domains: work-related activity, transportation, and recreational activity. It consists of 16 items that estimate the time spent in different intensities of activity (light, moderate, and vigorous), with results expressed in MET-minutes per week
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) is a valid and reliable instrument (α = 0.76) used to assess sleep quality. It consists of 19 self-reported items evaluating seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 suggests clinically relevant sleep disturbances.
Lower limb strength
The 30-Second Chair-Stand Test (30s-CST) is a validated functional test designed to assess lower-limb muscle strength and endurance. It consists of counting the number of times an individual can rise fully from a standard chair without using their arms within a 30-second period. A standard chair (43-45 cm high) is used, with the participant seated upright, feet flat on the floor and arms crossed over the chest. The outcome is expressed as the total number of correctly completed repetitions within 30 seconds, with higher scores indicating greater lower-limb strength and endurance.
Maximal oxygen uptake (V̇O2Max)
The Chester Step Test (CST) is a progressive submaximal test used to estimate maximal oxygen uptake (V̇O2Max). It involves stepping up and down on a fixed-height bench (typically 25-30 cm for most adults) following a progressively increasing pace set by a metronome or audio recording. The test consists of five two-minute stages, with cadence increasing at each stage until the participant reaches 80% of their age-predicted maximum heart rate (220-age) or is unable to maintain the required pace. Throughout the test, heart rate and ratings of perceived exertion (RPE, Borg 6-20 scale) are recorded at the end of each stage.With this information VO2Max values are estimated. Unit of measure: mlO2/kg/min
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