Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT07253935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Therapeutic Exercise Integrated With Psychotherapy and Education in Patients With Depression
Sponsor:
MarcoMateoRiera
Organization:
Study Overview
Official Title:
Efficacy of a Combined Approach of Therapeutic Exercise, Psychotherapy, and Therapeutic Education in Patients With Depression: The ACTIDEP Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
This study is expected to contribute to the growing body of evidence supporting integrative, biobehavioral approaches to the management of depression. By combining exercise and education within a psychotherapeutic framework, the program seeks to promote behavioral activation, enhance perceived control, and improve overall quality of life. If effective, this model could serve as a scalable, cost-effective, and accessible intervention for patients with depressive disorders, expanding the role of physiotherapy and interdisciplinary collaboration in mental health care.
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.
This study is expected to contribute to the growing body of evidence supporting integrative, biobehavioral approaches to the management of depression. By combining exercise and education within a psychotherapeutic framework, the program seeks to promote behavioral activation, enhance perceived control, and improve overall quality of life. If effective, this model could serve as a scalable, cost-effective, and accessible intervention for patients with depressive disorders, expanding the role of physiotherapy and interdisciplinary collaboration in mental health care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: