NCT01324050

Brief Summary

The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 2, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

March 25, 2011

Last Update Submit

August 1, 2011

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • Beck Depression Inventory (BDI)

    Two weeks before the treatment starts

  • Beck Depression Inventory (BDI)

    At treatment start (0 weeks)

  • Beck Depression Inventory (BDI)

    At treatment termination (10 weeks)

Secondary Outcomes (10)

  • Beck Anxiety Inventory (BAI)

    Two weeks before the treatment starts

  • Beck Anxiety Inventory (BAI)

    At treatment termination (10 weeks)

  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)

    Two weeks before treatment starts

  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)

    At treatment termination (10 weeks)

  • Quality of Life Inventory (QOLI)

    Two weeks before treatment starts

  • +5 more secondary outcomes

Study Arms (2)

Internet-based Psychodynamic Therapy

EXPERIMENTAL
Behavioral: Internet-delivered psychodynamic therapy for depression

Internet-delivered therapist support

ACTIVE COMPARATOR
Behavioral: Internet-delivered therapist support

Interventions

Internet-delivered psychodynamic therapy for depressionBEHAVIORAL

This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.

Internet-based Psychodynamic Therapy
Internet-delivered therapist supportBEHAVIORAL

This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.

Internet-delivered therapist support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Major Depressive Disorder
  • or more on MADRS-S

You may not qualify if:

  • Severe depression (more than 35 on MADRS-S or based on interview)
  • Severe psychiatric condition (e.g. psychosis or bipolar disorder)
  • Suicidal (measured in diagnostic interview)
  • Changed medication during the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linköping University, Department of Behavioral Sciences and Learning

Linköping, Sweden

Location

Linköping University

Linköping, Sweden

Location

Related Publications (2)

  • Johansson R, Nyblom A, Carlbring P, Cuijpers P, Andersson G. Choosing between Internet-based psychodynamic versus cognitive behavioral therapy for depression: a pilot preference study. BMC Psychiatry. 2013 Oct 18;13:268. doi: 10.1186/1471-244X-13-268.

    PMID: 24139066DERIVED

  • Johansson R, Ekbladh S, Hebert A, Lindstrom M, Moller S, Petitt E, Poysti S, Larsson MH, Rousseau A, Carlbring P, Cuijpers P, Andersson G. Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PLoS One. 2012;7(5):e38021. doi: 10.1371/journal.pone.0038021. Epub 2012 May 29.

    PMID: 22741027DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gerhard Andersson, PhD

    Department of Behavioral Sciences and Learning, Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 25, 2011

First Posted

March 28, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 2, 2011

Record last verified: 2011-01

Locations

SE(2)