Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
Primary Purpose
Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behaviour Therapy
Sponsored by
About this trial
This is an interventional basic science trial for Panic Disorder focused on measuring cognitive behaviour therapy
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70
- Sufficiently fluent in English to understand the task and instructions
- PDSS score of at least 6
- At least two full panic attacks or limited symptoms attacks last 4 weeks
Exclusion Criteria:
- CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3 days)
- Current or past history of alcohol/ drug abuse
- Serious medical conditions (e.g., epilepsy, heart or respiratory problems)
- Done the task before
- Waiting group: under current psychotherapeutic treatment
- Pregnancy
- Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement, metal implants
- Severe claustrophobia that limits ability to participate in fMRI scanning
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Waiting Group
Arm Description
Group receives four weekly sessions of CBT prior to experimental testing/ fMRI
Group receives four weekly sessions of CBT after experimental testing/ fMRI
Outcomes
Primary Outcome Measures
Emotional processing
Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)
Secondary Outcome Measures
Clinical symptom severity - Global anxiety and depression (self-report)
Hamilton Anxiety and Depression Scale HADS
Clinical symptom severity - Fear of physical sensations (self-report)
Body Sensations Questionnaire BSQ
Clinical symptom severity - Agoraphobic fear (self-report)
Agoraphobic Cognitions Questionnaire ACQ
Clinical symptom severity - Clinical severity and improvement (clinician-report)
Clinical Global Impression Scale CGI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03251235
Brief Title
Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
Official Title
Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
September 4, 2013 (Actual)
Study Completion Date
February 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
cognitive behaviour therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Group receives four weekly sessions of CBT prior to experimental testing/ fMRI
Arm Title
Waiting Group
Arm Type
No Intervention
Arm Description
Group receives four weekly sessions of CBT after experimental testing/ fMRI
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behaviour Therapy
Other Intervention Name(s)
CBT
Primary Outcome Measure Information:
Title
Emotional processing
Description
Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)
Time Frame
Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting
Secondary Outcome Measure Information:
Title
Clinical symptom severity - Global anxiety and depression (self-report)
Description
Hamilton Anxiety and Depression Scale HADS
Time Frame
Baseline, after 4 weeks treatment/ waiting
Title
Clinical symptom severity - Fear of physical sensations (self-report)
Description
Body Sensations Questionnaire BSQ
Time Frame
Baseline, after 4 weeks treatment/ waiting
Title
Clinical symptom severity - Agoraphobic fear (self-report)
Description
Agoraphobic Cognitions Questionnaire ACQ
Time Frame
Baseline, after 4 weeks treatment/ waiting
Title
Clinical symptom severity - Clinical severity and improvement (clinician-report)
Description
Clinical Global Impression Scale CGI
Time Frame
Baseline, after 4 weeks treatment/ waiting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70
Sufficiently fluent in English to understand the task and instructions
PDSS score of at least 6
At least two full panic attacks or limited symptoms attacks last 4 weeks
Exclusion Criteria:
CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3 days)
Current or past history of alcohol/ drug abuse
Serious medical conditions (e.g., epilepsy, heart or respiratory problems)
Done the task before
Waiting group: under current psychotherapeutic treatment
Pregnancy
Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement, metal implants
Severe claustrophobia that limits ability to participate in fMRI scanning
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30341276
Citation
Reinecke A, Thilo KV, Croft A, Harmer CJ. Early effects of exposure-based cognitive behaviour therapy on the neural correlates of anxiety. Transl Psychiatry. 2018 Oct 19;8(1):225. doi: 10.1038/s41398-018-0277-5.
Results Reference
derived
Learn more about this trial
Neural Effects of Cognitive-behaviour Therapy in Panic Disorder
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