Efficacy of a Combined Approach of Therapeutic Exercise, Psychotherapy, and Therapeutic Education in Patients With Depression: The ACTIDEP Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- Depressive symptoms
研究概览
简要总结
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.
详细描述
Depressive disorder is one of the most prevalent and disabling mental health conditions worldwide. Although pharmacological and psychological treatments remain the cornerstone of care, many patients continue to experience residual symptoms, recurrent episodes, or limitations in daily functioning and quality of life. In recent years, exercise-based interventions have gained recognition as a valuable adjunct to conventional treatment, showing beneficial effects on mood regulation, physical health, and overall well-being. Nonetheless, the most effective ways to integrate structured exercise, therapeutic education, and psychotherapy within a coordinated, patient-centered framework are still not well established.
This randomized controlled trial aims to examine the effects of a biobehavioral physiotherapy program that combines graded activity, therapeutic exercise, and patient education delivered concurrently with conventional psychotherapy. The rationale for this combined approach lies in addressing both physical and behavioral components of depression through a structured, progressive, and individualized program. Graded activity is designed to progressively increase patient´s tolerance to physical effort and promote engagement in meaningful daily tasks, while therapeutic education targets maladaptive beliefs about pain, fatigue, and activity avoidance. Together, these components aim to enhance self-efficacy, functional performance, and adherence to recovery-oriented behaviors.
The intervention will be delivered online under professional supervision, ensuring accessibility and continuity of care. The program will last eight weeks and will include structured exercise sessions emphasizing strength, mobility, and aerobic capacity, as well as educational modules focused on pacing, goal setting, and self-management strategies. The use of telehealth enables real-time monitoring, feedback, and personalized adjustments to exercise dosage and progression. Participants in the control group will continue receiving conventional psychotherapy for depression, following their regular clinical routine.
To ensure methodological rigor, randomization will be computer-generated with a 1:1 allocation ratio. Outcome assessments will be conducted by an independent evaluator blinded to group allocation. Standardized and validated measures will be used to assess depressive symptoms, quality of life, physical activity levels, functional capacity, self-efficacy, and sleep quality. Assessments will occur at baseline, mid-intervention, post-intervention, and 12-week follow-up to capture both immediate and sustained effects of the program.
Data will be analyzed following an intention-to-treat approach. Analysis of covariance (ANCOVA) and repeated-measures models will be applied to determine between-group differences and time-by-group interactions, adjusting for baseline scores and potential covariates. Effect sizes will be calculated to estimate the magnitude of the observed effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and care providers cannot be masked due to the nature of the exercise intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy.
- •Presence of neurological comorbidities or neurological signs.
- •Systemic rheumatic diseases, including fibromyalgia.
- •Central nervous system disorders.
- •Severe cognitive impairment.
- •Schizophrenia, psychotic disorders, or bipolar spectrum disorders.
研究组 & 干预措施
Psychotherapy
Conventional psychotherapy for the treatment of depression.
干预措施: Psychotherapy (Behavioral)
Exercise, therapeutic education and psychotherapy
Graded activity in combination with exercise, therapeutic education and psychotherapy
干预措施: Psychotherapy (Behavioral)
Exercise, therapeutic education and psychotherapy
Graded activity in combination with exercise, therapeutic education and psychotherapy
干预措施: Graded activity combined with exercise and education (Behavioral)
结局指标
主要结局
Depressive symptoms
时间窗: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
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
时间窗: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
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
次要结局
- Physical activity levels(From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.)
- Sleep quality(From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment)
- Lower limb strength(From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment)
- Maximal oxygen uptake (V̇O2Max)(From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment)
- Self-Efficacy to Regulate Exercise(From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment)