Randomised Controlled Trial of Cognitive Behavioural Therapy for the Treatment of Anxiety and Depression in Parkinson’s Disease

Not Applicable

• Conditions: Parkinson's Disease; Depression; Anxiety; Mental Health - Depression; Mental Health - Anxiety; Neurological - Parkinson's disease

• Registration Number: ACTRN12610000455066
• Lead Sponsor: Curtin University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1) At least 6-months post-diagnosis of Parkinson’s Disease
2) Stable use of antiparkinsonism medications
3) Meet the criteria for depression and/or any anxiety disorder as outlined in the American Psychiatric Association's
Diagnostic and Statistical Manual of Mental Disorders Version 4; Text-Revision (DSM-IV-TR)
4) If on antidepressant medication, this must have been stabilised (same medication and dosage) for at least 3 months prior to baseline assessment
5) If on antidepressant medication, agreement to remain on the same medication and dosage over the duration of the study where possible
6) Agreement to not pursue other psychological treatments during the course of the study and over the 6-month follow-up period.

Exclusion Criteria

1) Undergoing concurrent psychological treatment
2) Individuals who exhibit cognitive impairment (defined as a Mini Mental State Examination score < 24)
3) Meet DSM-IV-TR criteria for Psychosis
4) Show high suicide risk (defined as meeting the diagnosis for Current Suicidality as assessed by the Mini Neuropsychiatric Interview; MINI)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression (as measured by the Depression scale of the Depression, Anxiety and Stress Scale-21; DASS-21)[Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.]

Secondary Outcome Measures

Name	Time	Method
Anxiety (as measured by the Anxiety scale of the Depression, Anxiety and Stress Scale-21; DASS-21)[Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.];Stress (as measured by the Stress scale of the Depression, Anxiety and Stress Scale-21; DASS-21)[Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.];Parkinson's Disease specific Quality of Life (as measured by the Parkinson's Disease Questionnaire-39; PDQ-39).[Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.];Depressive and Anxious cognitions (as measured by the Cognitive Check-List; CCL)[Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.]