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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Parkinson's Disease; Insomnia; Anxiety
• Intervention / Treatment: Behavioral: ICBT; Behavioral: ICONTROL

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICBT; Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation	Behavioral: ICBT; 12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Active Comparator: ICONTROL; Internet-based treatment with a focus on relaxation training	Behavioral: ICONTROL; 12 weeks of Internet-based treatment with a focus on relaxation training
No Intervention: SMT; Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change (from baseline) in ISI	Insomnia Severity Index - self-report, to measure insomnia symptoms	12 weeks (Post), 3 and 6 months (FU)
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)
Change (from baseline) in EQ-5D	EQ-5D, to measure general health and quality of life	12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in SDS	Sheehan Disability Scale, to measure everyday level of functioning	12 weeks (Post), 3 and 6 months (FU)
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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Viktor Kaldo, Ph.D., Karolinska Institutet

Publications and helpful links

Helpful Links

• The public page of the Internet-CBT treatment platform

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Internet treatment; Self-help treatment; Internet-based Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Depressive Disorder; Parkinson Disease; Anxiety Disorders
• Other Study ID Numbers: ICBT Parkinson