Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity

NCT02369393 | Completed DMC

• 1 other identifier: UJaimeI06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.

Conditions

Major Depressive Disorder

Keywords

Internet based treatment; Depression; Efficacy; Cost-effectiveness; Behavioral Activation; Self-applied; Ecological Momentary Assessment; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire-9

  Change from baseline to 2 months, 5 months, and 8 months

• Change in the Beck Depression Inventory

  Change from baseline to 2 months, 5 months, and 8 months

Secondary Outcomes (10)

• Change in the EQ-5D-5L (EuroQol)

  Change from baseline to 2 months, 5 months, and 8 months

• Change in the Quality of Life (QLI)

  Change from baseline to 2 months, 5 months, and 8 months

• Change in the Overall Anxiety Severity and Impairment Scale (OASIS)

  Change from baseline to 2 months, 5 months, and 8 months

• Change in the Positive and Negative Affect Scale (PANAS)

  Change from baseline to 2 months, 5 months, and 8 months

• Change in the Happiness Scale (Fordyce)

  Change from baseline to 2 months, 5 months, and 8 months

Other Outcomes (11)

• Eysenck Personality Questionnaire-Revised Short Form (Neuroticism subscale)

  Baseline

• Credibility and expectancy questionnaire (CEQ)

  2 weeks

• Self concordance motivation (SCM)

  2 weeks

Study Arms (3)

Behavioral Activation

EXPERIMENTAL

BA treatment for depression is a simple, cost-effective method. There is evidence that the behavioral component may be the active mechanism of change in cognitive-behavioral treatments of clinical depression. One of the main objectives of the treatment is to systematically increase exposure to positive activities, and thereby improve affect and corresponding cognitions. Treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components are: 1) psycho-education, 2) identifying important values and significant activities, 3) activity structuring and scheduling, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support.

Behavioral: Behavioral Activation

Waiting list control group

NO INTERVENTION

In the waiting list control group (WL), subjects will receive no treatment during 8 weeks. We will not interfere but we will monitor carefully through self-report. Then participants will be randomised to the two treatment groups.

Physical Activity

EXPERIMENTAL

There is evidence to suggest that the addition of cognitive behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the PA treatment are: 1) psychoeducation: understand the mental health benefits of physical activity, 2) learn about the types and amounts of physical activity recommended, 3) motivation to perform and maintain physical activities, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support.

Behavioral: Physical Activity

Interventions

Behavioral Activation BEHAVIORAL

Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.

Behavioral Activation

Physical Activity BEHAVIORAL

Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.

Physical Activity

Eligibility Criteria

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

You may qualify if:

• Being 18 years of age or older
• Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
• A score of 5 or higher on the PHQ-9 screening questionnaire.

You may not qualify if:

• Current high risk for suicide according to the MINI Interview section C
• Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
• Currently receiving psychological treatment for depression in primary or specialised mental health care
• Being unable to comprehend the spoken and written language (Spanish)
• Not having access to a PC and fast Internet connection (i.e. broadband or comparable).

Sponsors & Collaborators

• Universitat Jaume I: lead
• University of Valencia: collaborator
• Universitat Politècnica de València: collaborator

Study Sites (1)

University Jaume I

Castellon, 12071, Spain

Location

Related Publications (30)

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MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cristina Botella, PhD

  Universitat Jaume I;CIBERObn ISC III, Spain

  PRINCIPAL INVESTIGATOR

• Rosa Baños, PhD

  Universitat de Valencia; CIBERObn ISC III, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: February 23, 2015
• Study Start: November 2, 2021
• Primary Completion: April 30, 2022
• Study Completion: February 1, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

ES (1)