Clinical trial NCT01619930: The Effects of Behavioral Activation and Physical Exercise on Depression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioral activation
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: Weekly during treatment period of 12 weeks
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: 24 hours
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: 12 months
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: 24 months
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: Monthly, 0-24 months
Secondary outcomes:
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 24 hours
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 12 months
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 24 months
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Monthly, 0-24 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: 24 hours
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: 12 months
measure: Change from baseline in the International Physical Activity Questionnaire (IPAQ)
timeFrame: 24 months
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 24 hours
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 12 months
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 24 months
measure: Change from baseline in MINI
timeFrame: Monthly, 0-24 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Psychology, Umeå University
state: Västerbotten
Study officials:
affiliation: Department of Psychology, Umeå University
name: Per Carlbring, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlbring P, Lindner P, Martell C, Hassmen P, Forsberg L, Strom 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.