Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 179 for:    "Panic Disorder"

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
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Panic Disorder Behavioral: Cognitive Behaviour Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Clinical symptom severity - Global anxiety and depression (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]
    Hamilton Anxiety and Depression Scale HADS

  2. Clinical symptom severity - Fear of physical sensations (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]
    Body Sensations Questionnaire BSQ

  3. Clinical symptom severity - Agoraphobic fear (self-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]
    Agoraphobic Cognitions Questionnaire ACQ

  4. Clinical symptom severity - Clinical severity and improvement (clinician-report) [ Time Frame: Baseline, after 4 weeks treatment/ waiting ]
    Clinical Global Impression Scale CGI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03251235     History of Changes
Other Study ID Numbers: 09/H0604/55
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oxford:
cognitive behaviour therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders