NCT00845260

Brief Summary

Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2004

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

February 17, 2009

Last Update Submit

February 17, 2009

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

  • Panic Disorder Severity Scale (PDSS)

    Pre, post at 6-month follow-up

Secondary Outcomes (1)

  • Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)

    Pre, post and 6-month follow-up

Study Arms (2)

Internet CBT

EXPERIMENTAL

Internet-based cognitive behavior therapy (CBT).

Behavioral: Internet-based cognitive behavior therapy (CBT).

Group CBT

EXPERIMENTAL

Group cognitive behavior therapy (CBT).

Behavioral: Group CBT

Interventions

Internet-based cognitive behavior therapy (CBT).BEHAVIORAL

Self-help program and guidance by psychologist via e-mail during 10 weeks.

Internet CBT
Group CBTBEHAVIORAL

Group cognitive behavior therapy (CBT) during 10 weeks.

Group CBT

Eligibility Criteria

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

You may qualify if:

  • Primary Panic Disorder with or without Agoraphobia (PD/A)

You may not qualify if:

  • active substance abuse
  • physiological etiology of panic symptoms
  • under 18 years of age
  • severe depression or suicidal ideation.
  • if on drugs for PD, not having had a constant dosage for 2 months
  • undergoing other cognitive behavioral treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5

Stockholm, 171 76, Sweden

Location

Related Publications (2)

  • Lonsdorf TB, Ruck C, Bergstrom J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99. doi: 10.1186/1471-244X-10-99.

    PMID: 21110842DERIVED

  • Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54. doi: 10.1186/1471-244X-10-54.

    PMID: 20598127DERIVED

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Nils Lindefors, MD, PhD, professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

December 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

SE(1)