Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective
      intervention, but the brain mechanisms driving recovery are largely unknown. In this
      experimental medicine study, it will be investigated to what degree CBT affects neural
      markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes
      which might be crucial in the process of recovery as opposed to those seen following full
      treatment completion. Patients with panic disorder will be recruited and randomly allocated
      to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group
      not receiving any interventions until after the experimental procedure.
    

Detailed description: 
      PURPOSE The primary purpose is to enhance our understanding of the mechanisms essential in
      effective treatment of panic disorder.

      METHODS Design: The present study has a between-subjects design, including a waiting group of
      participants with panic symptoms and a treatment group of participants with panic symptoms
      who will receive cognitive-behavioural treatment before being tested.

      Participants: Twenty-eight volunteers with panic symptoms will be recruited. For participants
      who do meet the basic study criteria a phone screening appointment (10 - 30 mins) will be
      arranged to further screen for relevant inclusion and exclusion criteria. They will then be
      invited to the Department of Psychiatry for the pre-assessment session.

      Treatment: Within the study, the investigators will offer participants a brief CBT course of
      4 sessions, offered by the Lupina service. The Lupina Service forms part of the OBMH primary
      care Counselling & Psychology Service, based at the Warneford Hospital. It provides intensive
      individual CBT for panic disorder and agoraphobia and is staffed by trained graduate
      volunteer therapists. Potential therapists are psychology graduates with prior mental health
      experience, who are given 2 days' intensive training in CBT for panic disorder and
      agoraphobia by Alison Croft, Consultant Clinical Psychologist. They then receive group
      supervision of their clinical cases. Service evaluation indicates equivalent clinical
      outcomes for volunteer therapists relative to qualified clinical psychologists.

      Procedure: Participants will be randomly allocated to either the treatment group or the
      waiting group. On arrival to the pre-assessment session, participants will be given a copy of
      the information sheet (previously seen during the online screening and e-mailed/ posted to
      them). They will be invited to fill out the consent form. Screening for past or previous
      psychiatric illness will be achieved using a structured clinical interview (SCID). In
      addition, participants will be asked to complete a battery of questionnaires. They will also
      be familiarised with the procedure occurring on the scanning day. Any outstanding questions
      the participant has will be addressed. The visit lasts about 1 to 1 ½ hrs. After the
      pre-assessment, a 4 weeks follow-up appointment (post-assessment) will be arranged with all
      participants. Half of the participants will be referred for treatment in the LUPINA group
      during that time. At the post-assessment 4 weeks later, the participants will be asked to
      come to the OCMR (Oxford Clinical Resonance Imaging) Department at the John Radcliffe
      Hospital. The visit will last a total of 2½ to 3 hrs and include a scanning session lasting 1
      to 1 ½ hrs. Subjective mood will be assessed on the day of the scan using the State form of
      the State-Trait Anxiety Inventory, a Mood Visual Analogue Scale and the Positive and Negative
      Affect Schedule. In addition, subjects will again complete the questionnaires from the
      pre-assessment. After the scan, participants will work on two behavioural computer tasks
      using emotional faces and word stimuli to assess facial recognition and attention outside the
      scanner. At the end of the session, patients from the waiting group will be offered the
      taster-CBT treatment within the LUPINA service.
    

Intervention name(s): Cognitive Behaviour Therapy
Intervention type(s): Behavioral
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: cognitive behaviour therapy