Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03251235|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder||Behavioral: Cognitive Behaviour Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.|
|Primary Purpose:||Basic Science|
|Official Title:||Neural Effects of Cognitive-behaviour Therapy in Panic Disorder|
|Actual Study Start Date :||January 1, 2011|
|Actual Primary Completion Date :||September 4, 2013|
|Actual Study Completion Date :||February 1, 2016|
Experimental: Treatment Group
Group receives four weekly sessions of CBT prior to experimental testing/ fMRI
Behavioral: Cognitive Behaviour Therapy
Other Name: CBT
No Intervention: Waiting Group
Group receives four weekly sessions of CBT after experimental testing/ fMRI
- Emotional processing [ Time Frame: Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting ]Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)
- Clinical symptom severity - Global anxiety and depression (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]Hamilton Anxiety and Depression Scale HADS
- Clinical symptom severity - Fear of physical sensations (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]Body Sensations Questionnaire BSQ
- Clinical symptom severity - Agoraphobic fear (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]Agoraphobic Cognitions Questionnaire ACQ
- Clinical symptom severity - Clinical severity and improvement (clinician-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]Clinical Global Impression Scale CGI