The Effects of Behavioral Activation and Physical Exercise on Depression

Umeå University

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Behavioral activation with rationale; Behavioral: Behavioral activation without rationale; Behavioral: Physical activity without motivational interviewing; Behavioral: Physical exercise with motivational interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT01619930

ACTUA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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319 participants in 9 patient groups

1a

Experimental group

Description:

In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)

Treatment:

Behavioral: Physical activity without motivational interviewing

1b

Experimental group

Description:

In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)

Treatment:

Behavioral: Physical activity without motivational interviewing

2a

Experimental group

Description:

In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)

Treatment:

Behavioral: Physical exercise with motivational interviewing

2b

Experimental group

Description:

In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)

Treatment:

Behavioral: Physical exercise with motivational interviewing

3a

Experimental group

Description:

In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)

Treatment:

Behavioral: Behavioral activation with rationale

3b

Experimental group

Description:

In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)

Treatment:

Behavioral: Behavioral activation with rationale

4a

Experimental group

Description:

In phase 1, group 4 undergoes behavioral activation without added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)

Treatment:

Behavioral: Behavioral activation without rationale

4b

Experimental group

Description:

In phase 1, group 4 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)

Treatment:

Behavioral: Behavioral activation without rationale

Phase 1 Waiting list control group

No Intervention group

Description:

Control group during phase 1, in parallel with treatment groups 1-4. Weekly self-report measurements, the results of which are conveyed in the form of individualized feedback. After 12 weeks, the participants of the control group (n = 100) are randomized to one four phase 1 active treatment groups (1-4) and receive treatment accordingly.