Impact of Therapeutic Exercise Integrated With Psychotherapy and Education in Patients With Depression

NCT07253935 | Not Yet Recruiting

• 1 other identifier: ACTIDEP2025RCT
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression Disorder

Keywords

Mental disorders; Depression; Exercise; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.

• 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

  From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.

Secondary Outcomes (5)

• 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

Study Arms (2)

Psychotherapy

ACTIVE COMPARATOR

Conventional psychotherapy for the treatment of depression.

Behavioral: Psychotherapy

Exercise, therapeutic education and psychotherapy

EXPERIMENTAL

Graded activity in combination with exercise, therapeutic education and psychotherapy

Behavioral: Psychotherapy; Behavioral: Graded activity combined with exercise and education

Interventions

Psychotherapy BEHAVIORAL

Conventional psychotherapy for depression, including Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy, Interpersonal Therapy, and Mindfulness-Based Cognitive Therapy.

Also known as: Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy

Exercise, therapeutic education and psychotherapy; Psychotherapy

Graded activity combined with exercise and education BEHAVIORAL

This 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

Also known as: Biobehavioral physiotherapy, Therapeutic education, Exercise Therapy

Exercise, therapeutic education and psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarcoMateoRiera: lead

Related Publications (3)

• Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.

  PMID: 11485122 BACKGROUND

• Favela Ramírez, C. A., Castro Robles, A. I., Bojórquez Díaz, C. I., & Chan Barocio, N. L. (2022). Propiedades psicométricas del índice de calidad de sueño de Pittsburgh en deportistas. riccafd: Revista Iberoamericana de Ciencias de la Actividad Física y el Deporte, 11(3), 29-46. https://dialnet.unirioja.es/servlet/articulo?codigo=8736227

  BACKGROUND

• Lein DH Jr, Alotaibi M, Almutairi M, Singh H. Normative Reference Values and Validity for the 30-Second Chair-Stand Test in Healthy Young Adults. Int J Sports Phys Ther. 2022 Aug 1;17(5):907-914. doi: 10.26603/001c.36432. eCollection 2022.

  PMID: 35949374 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Depression; Motor Activity

Interventions

Psychotherapy; Acceptance and Commitment Therapy; Cognitive Behavioral Therapy; Exercise; Educational Status; Exercise Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Behavior Therapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Roy La Touche, PhD

CONTACT

+34 917401980; roylatouche@lasallecampus.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and care providers cannot be masked due to the nature of the exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11