Panic Disorder (With or Without Agoraphobia)NCT01606592

Psychotherapy Outcome and Self-selection Effects in Panic Disorder

A study testing Panic-Focused Psychodynamic Psychotherapy (PFPP) and Waiting-list in people with Panic Disorder (With or Without Agoraphobia), run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Panic Disorder (With or Without Agoraphobia)
What is being tested?: Panic-Focused Psychodynamic Psychotherapy (PFPP) and Waiting-list
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteSweden
Study dates: Jan 2010to Feb 2021
Phase: Interventional
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia
Age between 18 and 60
Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up
Ability to complete the active treatment phase (not including follow-ups) within 16 weeks

Who cannot join

Active substance dependence (6 months remission necessary)
Current psychosis, delusions, mania, or active addiction
Acute suicidality
A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered
Active involvement in a legal dispute related to their mental health issues
Three or more unexcused absences

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Lund University
Lund, SE-221 00

Other trials in Sweden

About this study

Official title: Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions

The efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. The basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.

Read the detailed description

After thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. In the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95 persons are offered, after adequate information, to choose which of the two they prefer. Twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT; SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.

Conditions: Panic Disorder (With or Without Agoraphobia)
Being tested: Panic Control Treatment (PCT), Panic-Focused Psychodynamic Psychotherapy (PFPP), Waiting-list
Medical subject headings: Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Panic Control Treatment (PCT)Behavioural
Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
Panic-Focused Psychodynamic Psychotherapy (PFPP)Behavioural
Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
Waiting-listOther
Sparse telephone contact during 12 weeks, then re-randomization

Study groups in NCT01606592
Study group	Role	What they receive
Randomized Panic Control Treatment	Experimental	Patients who have been randomized to the randomization condition are assigned to PCT Receives: Behavioral: Panic Control Treatment (PCT)
Randomized Panic-Focused Psychodynamic Psychotherapy	Experimental	Patients who have been randomized to the randomization condition are assigned to PFPP Receives: Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
Self-selected Panic Control Treatment	Experimental	Patients who have been randomized to the self-selection condition choose PCT Receives: Behavioral: Panic Control Treatment (PCT)
Self-selected Panic-Focussed Psychodynamic Psychotherapy	Experimental	Patients who have been randomized to the self-selection condition choose PFPP Receives: Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)
Waiting-list	Experimental	Patients who have been randomized to the waiting-list are offered sparse contact over telephone for 12 weeks and are then re-randomized to one of the other four arms Receives: Other: Waiting-list

What is being measured

The primary outcome is the main question the study is designed to answer.

Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
Measured: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in occupational status
Measured: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in absence from work due to sickness
Measured: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination

Secondary outcomes (4)

Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)
Measured: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in health care utilization (number of medical contacts, and emergency visits, medication)
Measured: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)
Measured: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)
Measured: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Feb 2021

First posted25 May 2012 (estimated)
Study startJan 2010
Primary completionJun 2019
Study completionFeb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Panic Disorder (With or Without Agoraphobia)Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01606592
Sponsor's protocol ID: POSE
Status last verified: Mar 2021
First submitted: 19 Mar 2012
Last updated: 12 Mar 2021
Results posted: No
Data monitoring committee: Yes

Publications

Nilsson T, Falkenstrom F, Perrin S, Svensson M, Johansson H, Sandell R. Exploring termination setback in a psychodynamic therapy for panic disorder. J Consult Clin Psychol. 2021 Sep;89(9):762-772. doi: 10.1037/ccp0000678.
PubMed 34591549
Svensson M, Nilsson T, Perrin S, Johansson H, Viborg G, Sandell R. Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why? Psychother Res. 2021 Jun;31(5):644-655. doi: 10.1080/10503307.2020.1839686. Epub 2020 Nov 5.
PubMed 33148129
Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S, Sandell R. Psychometric analysis of the Swedish panic disorder severity scale and its self-report version. Nord J Psychiatry. 2019 Jan;73(1):58-63. doi: 10.1080/08039488.2018.1554699. Epub 2019 Jan 14.
PubMed 30636466
Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.
PubMed 25873067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Panic Disorder (With or Without Agoraphobia) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
ClinicalTrials.gov ID: NCT01606592
Acronym / sponsor ID: POSE
Conditions: Panic Disorder (With or Without Agoraphobia)
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Region SkaneUniversity, hospital or other
Study start: Jan 2010 (actual)
Primary completion: Jun 2019 (actual)
Study completion: Feb 2021 (actual)
First posted: 25 May 2012 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Randomized Panic Control Treatment	Experimental	Behavioral: Panic Control Treatment (PCT)Patients who have been randomized to the randomization condition are assigned to PCT
Randomized Panic-Focused Psychodynamic Psychotherapy	Experimental	Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)Patients who have been randomized to the randomization condition are assigned to PFPP
Self-selected Panic Control Treatment	Experimental	Behavioral: Panic Control Treatment (PCT)Patients who have been randomized to the self-selection condition choose PCT
Self-selected Panic-Focussed Psychodynamic Psychotherapy	Experimental	Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)Patients who have been randomized to the self-selection condition choose PFPP
Waiting-list	Experimental	Other: Waiting-listPatients who have been randomized to the waiting-list are offered sparse contact over telephone for 12 weeks and are then re-randomized to one of the other four arms

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia
Age between 18 and 60
Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up
Ability to complete the active treatment phase (not including follow-ups) within 16 weeks

Key exclusion criteria (6 listed)

Active substance dependence (6 months remission necessary)
Current psychosis, delusions, mania, or active addiction
Acute suicidality
A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered
Active involvement in a legal dispute related to their mental health issues

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Panic Control Treatment (PCT)Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.	Behavioural	Randomized Panic Control Treatment, Self-selected Panic Control Treatment
Panic-Focused Psychodynamic Psychotherapy (PFPP)Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.	Behavioural	Randomized Panic-Focused Psychodynamic Psychotherapy, Self-selected Panic-Focussed Psychodynamic Psychotherapy
Waiting-listSparse telephone contact during 12 weeks, then re-randomization	Other	Waiting-list

Primary outcome

Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in occupational status
Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in absence from work due to sickness
Time frame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination

4 secondary outcomes

Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)
Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in health care utilization (number of medical contacts, and emergency visits, medication)
Time frame: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)
Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)
Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination

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 12 Mar 2021.
Derived from this study: PubMed 34591549Nilsson T, Falkenstrom F, Perrin S, Svensson M, Johansson H, Sandell R. Exploring termination setback in a psychodynamic therapy for panic disorder. J Consult Clin Psychol. 2021 Sep;89(9):762-772. doi: 10.1037/ccp0000678.
Derived from this study: PubMed 33148129Svensson M, Nilsson T, Perrin S, Johansson H, Viborg G, Sandell R. Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why? Psychother Res. 2021 Jun;31(5):644-655. doi: 10.1080/10503307.2020.1839686. Epub 2020 Nov 5.
Derived from this study: PubMed 30636466Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S, Sandell R. Psychometric analysis of the Swedish panic disorder severity scale and its self-report version. Nord J Psychiatry. 2019 Jan;73(1):58-63. doi: 10.1080/08039488.2018.1554699. Epub 2019 Jan 14.
Derived from this study: PubMed 25873067Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.

Related trials for Panic Disorder (With or Without Agoraphobia)

Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Active, not recruiting
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
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Recruiting
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Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD)
Not yet recruiting
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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.

Rolf Sandell, PhD principal investigator

Lund University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Panic-Focused Psychodynamic Psychotherapy (PFPP) and Waiting-list in people with Panic Disorder (With or Without Agoraphobia), run by Region Skane at 1 site in Sweden.

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 4 inclusion and 6 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 12 Mar 2021. 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 Sweden. 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.

What does the primary outcome measure?

Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997) (time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01606592, which also lists 4 linked publications.

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 12 Mar 2021.