NCT01312116

Brief Summary

The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

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

January 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

March 7, 2011

Last Update Submit

March 9, 2011

Conditions

Keywords

Internet treatmentGADguided self-help

Outcome Measures

Primary Outcomes (1)

  • Penn State Worry Questionnaire (PSWQ)

    Change from baseline in anxiety symptoms to two weeks post treatment.

    Two weeks pre treatment to two weeks post treatment.

Secondary Outcomes (7)

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

    Two weeks pre treatment to two weeks post treatment

  • Quality of Life Inventory (QOLI)

    Two weeks pre treatment to two weeks post treatment

  • Beck Depression Inventory (BDI)

    Two weeks pre treatment to two weeks post treatment

  • Beck Anxiety Inventory (BAI)

    Two weeks pre treatment to two weeks post treatment

  • Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)

    Two weeks pre treatment to two weeks post treatment

  • +2 more secondary outcomes

Study Arms (3)

Internet-delivered CBT

EXPERIMENTAL

Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help

Behavioral: iCBT

Internet-delivered PDT

EXPERIMENTAL

Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help

Behavioral: iPDT

Control condition

NO INTERVENTION

Wait-list condition, received treatment 3 months after initial treatment period

Interventions

iCBTBEHAVIORAL

Internet-delivered cognitive behavior therapy, 8 weeks

Internet-delivered CBT
iPDTBEHAVIORAL

Internet-delivered psychodynamic therapy, 8 weeks

Internet-delivered PDT

Eligibility Criteria

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

You may qualify if:

  • fulfill the diagnostic criteria for GAD according to DSM-IV
  • have access to the Internet
  • have good knowledge of the Swedish language

You may not qualify if:

  • recent (during last 6 weeks) change in psychiatric medication
  • presently in any other psychological treatment
  • severe depression
  • suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Östergötland County, 581 83, Sweden

Location

Related Links

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Gerhard Andersson, Professor

    Linkoeping University

    STUDY DIRECTOR

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 7, 2011

First Posted

March 10, 2011

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2010

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations