Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Behavioral: Cognitive Behaviour Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Group receives four weekly sessions of CBT prior to experimental testing/ fMRI	Behavioral: Cognitive Behaviour Therapy; Other Names: CBT
No Intervention: Waiting Group; Group receives four weekly sessions of CBT after experimental testing/ fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional processing	Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)	Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical symptom severity - Global anxiety and depression (self-report)	Hamilton Anxiety and Depression Scale HADS	Baseline, after 4 weeks treatment/ waiting
Clinical symptom severity - Fear of physical sensations (self-report)	Body Sensations Questionnaire BSQ	Baseline, after 4 weeks treatment/ waiting
Clinical symptom severity - Agoraphobic fear (self-report)	Agoraphobic Cognitions Questionnaire ACQ	Baseline, after 4 weeks treatment/ waiting
Clinical symptom severity - Clinical severity and improvement (clinician-report)	Clinical Global Impression Scale CGI	Baseline, after 4 weeks treatment/ waiting

Collaborators and Investigators

• Sponsor: University of Oxford

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): September 4, 2013
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cognitive behaviour therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: 09/H0604/55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No