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

Phase 3

Completed

• Conditions: Anxiety; Depression; Parkinson's Disease; Insomnia
• Interventions: Behavioral: ICONTROL; Behavioral: ICBT

• Registration Number: NCT01545414
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICONTROL	ICONTROL	Internet-based treatment with a focus on relaxation training
ICBT	ICBT	Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation

Primary Outcome Measures

Name	Time	Method
Change (from baseline) in HADS	12 weeks (Post), 3 and 6 months (FU)	Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression

Secondary Outcome Measures

Name	Time	Method
Change (from baseline) in MADRS-S	12 weeks (Post), 3 and 6 months (FU)	Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression
Change (from baseline) in ISI	12 weeks (Post), 3 and 6 months (FU)	Insomnia Severity Index - self-report, to measure insomnia symptoms
Change (from baseline) in PDQ-8	12 weeks (Post), 3 and 6 months (FU)	The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients
Change (from baseline) in NMSQuest	12 weeks (Post), 3 and 6 months (FU)	Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD
Change (from baseline) in EQ-5D	12 weeks (Post), 3 and 6 months (FU)	EQ-5D, to measure general health and quality of life
Change (from baseline) in SDS	12 weeks (Post), 3 and 6 months (FU)	Sheehan Disability Scale, to measure everyday level of functioning

Trial Locations

Locations (1)

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO; 🇸🇪 Stockholm, Sweden