NCT01545414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

March 1, 2012

Last Update Submit

February 12, 2015

Conditions

Parkinson's DiseaseDepressionAnxietyInsomnia

Keywords

Self-help treatmentInternet treatmentCognitive Behavioral TherapyInternet-based Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Change (from baseline) in MADRS-S

    12 weeks (Post), 3 and 6 months (FU)

  • Change (from baseline) in ISI

    12 weeks (Post), 3 and 6 months (FU)

  • Change (from baseline) in PDQ-8

    12 weeks (Post), 3 and 6 months (FU)

  • Change (from baseline) in EQ-5D

    12 weeks (Post), 3 and 6 months (FU)

  • Change (from baseline) in SDS

    12 weeks (Post), 3 and 6 months (FU)

  • +1 more secondary outcomes

Study Arms (3)

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

ICBTBEHAVIORAL

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

ICBT
ICONTROLBEHAVIORAL

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

ICONTROL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson's Disease
  • At least mild to moderate depression or anxiety defined as HADS-A or HADS-D \> 7

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Stockholm, Sweden

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseDepressionAnxiety DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Viktor Kaldo, Ph.D.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

SE(1)