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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
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Panic Disorder focused on measuring cognitive behaviour therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 31, 2017
    Last Updated
    August 11, 2017
    Sponsor
    University of Oxford
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    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

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    Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

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