Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease

Depression Clinical Trial

Official title:

Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545414
• Other study ID #: ICBT Parkinson
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2012
• Last updated: February 12, 2015
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's Disease

• At least mild to moderate depression or anxiety defined as HADS-A or HADS-D > 7

Exclusion Criteria:

• Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview

• Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)

• Difficulties that hamper the use of a computer

• The patient states difficulties in finding enough time for treatment

• Too low cognitive functioning defined as MoCA < 24

• Too severe depression, defined as MADRS-S over 30

• Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Insomnia
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• ICBT
12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
• ICONTROL
12 weeks of Internet-based treatment with a focus on relaxation training

Locations

Country	Name	City	State
Sweden	Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (from baseline) in HADS	Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in MADRS-S	Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in ISI	Insomnia Severity Index - self-report, to measure insomnia symptoms	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in PDQ-8	The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in EQ-5D	EQ-5D, to measure general health and quality of life	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in SDS	Sheehan Disability Scale, to measure everyday level of functioning	12 weeks (Post), 3 and 6 months (FU)	No
Secondary	Change (from baseline) in NMSQuest	Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD	12 weeks (Post), 3 and 6 months (FU)	No

External Links

•   The public page of the Internet-CBT treatment platform