NCT03061448

Brief Summary

The purpose of this study is examine if an internet-based exposure therapy based on inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst patients who suffer from panic disorder and agoraphobia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 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

February 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

February 19, 2017

Last Update Submit

August 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Panic Disorder Severity Scale - Self rated (PDSS-SR)

    Change in panic symptoms from baseline to Week 8

    Week 0, Week 8

Secondary Outcomes (12)

  • Credibility/Expectancy Questionnaire (CEQ)

    Week 2

  • Client Satisfaction Questionnaire (CSQ)

    Week 8

  • Adverse events scale

    Week 8

  • Patient Health Questionnaire (PHQ-9)

    Week 0, Week 8

  • Anxiety Sensitivity Index (ASI)

    Week 0, Week 8

  • +7 more secondary outcomes

Study Arms (2)

Inhibitory learning based treatment

EXPERIMENTAL

The experimental group will go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of inhibitory learning, i.e. the participant is instructed to stay in the frightening situation until his/her expectancy has been maximally violated.

Behavioral: Internet-based cognitive-behavior therapy

Habituation based treatment

ACTIVE COMPARATOR

The active comparator group will also go through Internet-based treatment. The exposure treatment is 8 weeks long and based on the principles of emotional processing theory, i.e. the participant is instructed to stay in the frightening situation until anxiety has declined (habituated).

Behavioral: Internet-based cognitive-behavior therapy

Interventions

Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.

Habituation based treatmentInhibitory learning based treatment

Eligibility Criteria

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

You may qualify if:

  • Outpatients
  • ≥ 18 years
  • Situated in Sweden
  • Informed consent
  • Panic Disorder Severity Scale - self rated score more than 6 points

You may not qualify if:

  • Substance dependence during the last six months
  • Post traumatic stress disorder, bipolar disorder or psychosis
  • Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
  • MADRS-S score above 25 points
  • Psychotropic medication changes within one months prior to treatment that could affect target symptoms.
  • Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Study Officials

  • Erik M Andersson, PhD

    Karolinska Institutet

    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
PhD, psychologist

Study Record Dates

First Submitted

February 19, 2017

First Posted

February 23, 2017

Study Start

February 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations