AgoraphobiaNCT01446172
Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia
An observational study of Agoraphobia, run by Modum Bad at 1 site in Norway.
Trial summary
While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Agoraphobia
- How many people
- 132 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with panic disorder with or without agoraphobia and/or agoraphobia without history of panic disorder who have accepted treatment at an inpatient psychiatric hospital
Who may be able to join
- Meet the DSM-IV kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia
Who cannot join
- psychosis
- dementia
- substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Panic Disroder and Agoraphobia
While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned.
The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy.
Read more
In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments.
The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.
- Conditions
- Agoraphobia
- Keywords
- Long term outcome
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cognitive, schema focused, guided mastery, exposure | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgoraphobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446172
- Sponsor's protocol ID
- Hedley-1
- Status last verified
- Apr 2012
- First submitted
- 3 Oct 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Panic Disroder and Agoraphobia
- ClinicalTrials.gov ID
- NCT01446172
- Acronym / sponsor ID
- Hedley-1
- Conditions
- Agoraphobia
- Keywords
- Long term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned.
The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy.
In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments.
The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive, schema focused, guided mastery, exposure | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with panic disorder with or without agoraphobia and/or agoraphobia without history of panic disorder who have accepted treatment at an inpatient psychiatric hospital
Key inclusion criteria (1 listed)
- Meet the DSM-IV kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia
Key exclusion criteria (3 listed)
- psychosis
- dementia
- substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Agoraphobia, run by Modum Bad at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.