NCT01532219

Brief Summary

The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders 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
100

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

February 9, 2012

Last Update Submit

April 23, 2013

Conditions

DepressionAnxiety

Outcome Measures

Primary Outcomes (8)

  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9)

    Two weeks before the treatment starts

  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)

    Two weeks before the treatment starts

  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9)

    At treatment start (0 weeks)

  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)

    At treatment start (0 weeks)

  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9)

    At treatment termination (10 weeks)

  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)

    At treatment termination (10 weeks)

  • 9-item Patient Health Questionnaire Depression Scale (PHQ-9)

    At treatment follow-up (7 months)

  • 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)

    At treatment follow-up (7 months)

Secondary Outcomes (8)

  • Emotional Processing Scale (EPS-25)

    Two weeks before the treatment starts

  • Emotional Processing Scale (EPS-25)

    At treatment start (0 weeks)

  • Emotional Processing Scale (EPS-25)

    At treatment termination (10 weeks)

  • Five Facets of Mindfulness Questionnaire (FFMQ)

    Two weeks before the treatment starts

  • Five Facets of Mindfulness Questionnaire (FFMQ)

    At treatment start (0 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Internet-delivered Psychodynamic Treatment

EXPERIMENTAL

Participants in the experimental condition will receive 8 text-modules delivered as guided self-help, via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail. The treatment is a short-term psychodynamic treatment psychodynamic treatment.

Behavioral: Internet-delivered Psychodynamic Treatment

Internet-delivered structured support

ACTIVE COMPARATOR

Participants in the active control condition will receive a structured support treatment via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail.

Behavioral: Internet-delivered structured support

Interventions

Internet-delivered Psychodynamic TreatmentBEHAVIORAL

Ten weeks of guided self-help + therapist contact, via the Internet.

Internet-delivered Psychodynamic Treatment
Internet-delivered structured supportBEHAVIORAL

Ten weeks of therapist contact, via the Internet.

Internet-delivered structured 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, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
  • or higher on the PHQ-9 or on the GAD-7 at pre-treatment

You may not qualify if:

  • Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
  • Severe psychiatric condition (e.g. psychosis or bipolar disorder)
  • Alcohol abuse (more than 16 on the AUDIT)
  • Suicidal (measured in diagnostic interview)
  • Changed medication during the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University, Department of Behavioral Sciences and Learning

Linköping, 58183, Sweden

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

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

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 14, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

SE(1)