NCT01619930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
319

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

June 12, 2012

Last Update Submit

October 31, 2016

Conditions

Depression

Keywords

DepressionBehavioral activation

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (11)

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    24 hours

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    12 months

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    24 months

  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Monthly, 0-24 months

  • Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    24 hours

  • +6 more secondary outcomes

Study Arms (9)

1a

EXPERIMENTAL

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)

Behavioral: Physical activity without motivational interviewing

1b

EXPERIMENTAL

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)

Behavioral: Physical activity without motivational interviewing

2a

EXPERIMENTAL

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)

Behavioral: Physical exercise with motivational interviewing

2b

EXPERIMENTAL

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)

Behavioral: Physical exercise with motivational interviewing

3a

EXPERIMENTAL

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)

Behavioral: Behavioral activation with rationale

3b

EXPERIMENTAL

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)

Behavioral: Behavioral activation with rationale

4a

EXPERIMENTAL

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)

Behavioral: Behavioral activation without rationale

4b

EXPERIMENTAL

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)

Behavioral: Behavioral activation without rationale

Phase 1 Waiting list control group

NO INTERVENTION

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.

Interventions

Physical activity without motivational interviewingBEHAVIORAL

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.

1a1b
Physical exercise with motivational interviewingBEHAVIORAL

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.

2a2b
Behavioral activation with rationaleBEHAVIORAL

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.

3a3b
Behavioral activation without rationaleBEHAVIORAL

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.

4a4b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90181, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 23374879BACKGROUND

  • Hlynsson JI, Kristjansson T, Andersson G, Carlbring P; ACTUA research group. Evaluating the necessity of booster sessions in relapse prevention for depression: a longitudinal study. Front Psychol. 2025 Jun 24;16:1568141. doi: 10.3389/fpsyg.2025.1568141. eCollection 2025.

    PMID: 40631058DERIVED

MeSH Terms

Conditions

Depression

Interventions

ExerciseMotivational Interviewing

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Per Carlbring, Professor

    Department of Psychology, Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2017

Study Completion

May 1, 2018

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

SE(1)