Psychotherapy Outcome and Self-selection Effects in Panic Disorder

Region Skane

Status: Completed

Conditions: Panic Disorder (With or Without Agoraphobia)

Treatments: Other: Waiting-list; Behavioral: Panic Control Treatment (PCT); Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01606592

POSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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216 participants in 5 patient groups

Randomized Panic Control Treatment

Experimental group

Description:

Patients who have been randomized to the randomization condition are assigned to PCT

Treatment:

Behavioral: Panic Control Treatment (PCT)

Randomized Panic-Focused Psychodynamic Psychotherapy

Experimental group

Description:

Patients who have been randomized to the randomization condition are assigned to PFPP

Treatment:

Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)

Self-selected Panic Control Treatment

Experimental group

Description:

Patients who have been randomized to the self-selection condition choose PCT

Treatment:

Behavioral: Panic Control Treatment (PCT)

Self-selected Panic-Focussed Psychodynamic Psychotherapy

Experimental group

Description:

Patients who have been randomized to the self-selection condition choose PFPP

Treatment:

Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)

Waiting-list

Experimental group

Description:

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

Treatment:

Other: Waiting-list