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

NCT ID: NCT01545414

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Parkinson's Disease Depression Anxiety Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICBT

Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation

Group Type EXPERIMENTAL

ICBT

Intervention Type BEHAVIORAL

12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation

ICONTROL

Internet-based treatment with a focus on relaxation training

Group Type ACTIVE_COMPARATOR

ICONTROL

Intervention Type BEHAVIORAL

12 weeks of Internet-based treatment with a focus on relaxation training

SMT

Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ICBT

12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation

Intervention Type BEHAVIORAL

ICONTROL

12 weeks of Internet-based treatment with a focus on relaxation training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Viktor Kaldo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viktor Kaldo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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http://www.internetpsykiatri.se

The public page of the Internet-CBT treatment platform

Other Identifiers

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ICBT Parkinson

Identifier Type: -

Identifier Source: org_study_id

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