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NCT Number: NCT01606592

Psychotherapy Outcome and Self-selection Effects in Panic Disorder

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.

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Key information

Conditions

Panic Disorder (With or Without Agoraphobia) Anxiety Disorders Mental Disorders Panic Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University

Lund, SE-221 00, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Panic Control Treatment (PCT)

Behavioral

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)

Behavioral

Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.

Waiting-list

Other

Sparse telephone contact during 12 weeks, then re-randomization

Primary outcomes

  1. 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

  2. Change in occupational status

    Time frame: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2021
First posted
May 25, 2012
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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