The Effects of Behavioral Activation and Physical Exercise on Depression

Not Applicable

• Conditions: Depression

• Registration Number: NCT01619930
• Lead Sponsor: Umeå University

Brief Summary

The purpose of this study is to compare an internet-based behavioral activation program with a physical activation program, as treatments for mild to moderate depression. The added effect of rationale and motivational interviewing will also be studied, as well as the effects of relapse prevention program.

Detailed Description

BACKGROUND:

Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

METHODS/DESIGN:

This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

DISCUSSION:

The results of this study will constitute an important contribution to the body of knowledge of the respective interventions.

Study Timeline

• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Study Start: 2012-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01
• Primary Completion: 2017-01
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

• Satisfy DSM-IV (or DSM-V) criteria for depression, with depression being primary diagnosis
• Scoring within the interval 15-35 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• Living in Sweden and being able to read Swedish
• Access to computer with internet connection

Exclusion Criteria

• Currently receiving other psychological treatment
• Non-stable use of psychoactive medication
• Deemed to suffer from a too severe depression
• Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Patient Health Questionnaire (PHQ-9)	Monthly, 0-24 months	The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the International Physical Activity Questionnaire (IPAQ)	24 months	The International Physical Activity Questionnaire is a measure of physical activity.
Change from baseline in Quality Of Life Inventory (QOLI)	24 months	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	Monthly, 0-24 months	7-item screening form for Generalized Anxiety Disorder.
Change from baseline in MINI	Monthly, 0-24 months	The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.

Trial Locations

Locations (1)

Department of Psychology, Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden