The Effects of Behavioral Activation and Physical Exercise on Depression

Depression Clinical Trial

Official title:

The Effects on Depression of Internet-administered Behavioural Activation and Physical Exercise With Treatment Rationale and Relapse Prevention: Study Protocol for a Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01619930
• Other study ID #: ACTUA
• Status: Active, not recruiting
• Phase: N/A
• First received: June 12, 2012
• Last updated: October 31, 2016
• Start date: August 2012
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 319
• Est. completion date: May 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Physical activity without motivational interviewing
Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback.
• Physical exercise with motivational interviewing
Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback. An initial motivational interview (MI) per telephone is also conducted, to explore the intrinsic motivation to change in participants.
• Behavioral activation with rationale
A behavioral activation program, based on the TRAP-TRAC model according to which suffering individuals are trapped in a vicious circle of avoidance and ever fewer reinforcers, leading to increasing discomfort. To break free of this vicious circle, patients have to replace avoidance patterns with alternative coping strategies. Unlike previous applications of this program done in the U.S., this study will feature an internet-based administration. Approximately 15 minutes of electronic therapist support will be included per week.
• Behavioral activation without rationale
A behavioral activation program without TRAP-TRAC rationale, but with some encouragement provided ("Activate yourself and feel better!"). Approximately 15 minutes of electronic therapist support will be included per week.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Carlbring P, Lindner P, Martell C, Hassmén P, Forsberg L, Ström L, Andersson G. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial. Trials. 2013 Feb 2;14:35. doi: 10.1186/1745-6215-14-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Patient Health Questionnaire (PHQ-9)	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).	Weekly during treatment period of 12 weeks	No
Primary	Change from baseline in Patient Health Questionnaire (PHQ-9)	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).	24 hours	No
Primary	Change from baseline in Patient Health Questionnaire (PHQ-9)	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).	12 months	No
Primary	Change from baseline in Patient Health Questionnaire (PHQ-9)	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).	24 months	No
Primary	Change from baseline in Patient Health Questionnaire (PHQ-9)	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).	Monthly, 0-24 months	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	24 hours	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	12 months	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	24 months	No
Secondary	Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)	7-item screening form for Generalized Anxiety Disorder.	Monthly, 0-24 months	No
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity.	24 hours	No
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity.	12 months	No
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity.	24 months	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	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.	24 hours	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	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.	12 months	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	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.	24 months	No
Secondary	Change from baseline in MINI	The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.	Monthly, 0-24 months	No