Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

NCT03251235 | Completed

• 1 other identifier: 09/H0604/55
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panic Disorder

Keywords

cognitive behaviour therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical symptom severity - Global anxiety and depression (self-report)

  Baseline, after 4 weeks treatment/ waiting

• Clinical symptom severity - Fear of physical sensations (self-report)

  Baseline, after 4 weeks treatment/ waiting

• Clinical symptom severity - Agoraphobic fear (self-report)

  Baseline, after 4 weeks treatment/ waiting

• Clinical symptom severity - Clinical severity and improvement (clinician-report)

  Baseline, after 4 weeks treatment/ waiting

Study Arms (2)

Treatment Group

EXPERIMENTAL

Group receives four weekly sessions of CBT prior to experimental testing/ fMRI

Behavioral: Cognitive Behaviour Therapy

Waiting Group

NO INTERVENTION

Group receives four weekly sessions of CBT after experimental testing/ fMRI

Interventions

Cognitive Behaviour Therapy BEHAVIORAL

Also known as: CBT

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Related Publications (1)

• 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.

  PMID: 30341276 DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 16, 2017
• Study Start: January 1, 2011
• Primary Completion: September 4, 2013
• Study Completion: February 1, 2016
• Last Updated: August 16, 2017

Record last verified: 2017-08