Internet-CBT (Cognitive Behavioral Therapy) for Depressio... | NCT01545414

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

NCT01545414

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Parkinson's Disease
Depression
Anxiety
Insomnia

Interventions

ICBT
ICONTROL

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Name	Class
Region Stockholm	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICBT	Experimental	Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation	Behavioral: ICBT
ICONTROL	Active Comparator	Internet-based treatment with a focus on relaxation training	Behavioral: ICONTROL
SMT	No Intervention	Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICBT	Behavioral	12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation	ICBT

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Viktor Kaldo, Ph.D.	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO		Stockholm			Sweden

Label	URL
The public page of the Internet-CBT treatment platform	View source

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D003863	Depression
D001008	Anxiety Disorders
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided