NCT02627885

Brief Summary

The aim of the study is to investigate if an Internet-based psychological treatment based on principles from Cognitive Behavioral Therapy can increase function and quality of life for patients with Parkinson disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

December 9, 2015

Last Update Submit

January 5, 2020

Conditions

Parkinson Disease

Keywords

internet treatmentcognitive behavioral therapylevel of functioningquality of life

Outcome Measures

Primary Outcomes (1)

  • Change (from baseline) in WSAS

    The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning

    Baseline, nine weekly measure while in treatment, then the primary endpoint is after 10 weeks of treatment (Post), and there will also be up to two follow-up (FU) measures within 3 years from treatment completion

Secondary Outcomes (8)

  • Change (from baseline) in IPAQ

    Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures

  • Change (from baseline) in SVAQ

    Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures

  • Change (from baseline) in WHODAS-2

    Baseline, 10 weeks (Post) and up to 2 (FU) measures

  • Change (from baseline) in PDQ-8

    Baseline, 10 weeks (Post) and up to 2 (FU) measures

  • Change (from baseline) in BBQ

    Baseline, 10 weeks (Post) and up to 2 (FU) measures

  • +3 more secondary outcomes

Other Outcomes (7)

  • Adverse Events (self-rated)

    5 weeks (Mid) and 10 weeks (Post)

  • Adverse Events (therapist-rated)

    5 weeks (Mid) and 10 weeks (Post)

  • Adverse Events (interviewer-rated)

    10 weeks (Post)

  • +4 more other outcomes

Study Arms (2)

ICBT

ACTIVE COMPARATOR

Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment

Behavioral: Internet-based CBT

SMT

OTHER

Standard Medical Treatment for Parkinsons Disease only

Other: SMT

Interventions

Internet-based CBTBEHAVIORAL

Through the use of CBT material at an Internet-platform, we aim for behavioral changes in the subjects to improve everyday level of functioning and quality of life.

ICBT
SMTOTHER

Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions

SMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed Parkinson disease
  • WSAS score of over 17
  • Access to a internet connected device and a mobile phone capable of receiving SMS

You may not qualify if:

  • Substance or alcohol abuse
  • Psychotic Disorder or Bipolar disorder
  • Other psychiatric disorder that requires immediate attention or hinders the offered ICBT treatment
  • Practical obstacles such as difficulties using the technology required to participate in the study, not having the time to actively wok with the treatment, or having symptoms from Parkinson to severe to be able to actively participate in the study
  • High suicide risk, defined as:
  • or 6 points on the question about Suicidal thoughts on the Montgomery-Asberg Depression Scale (MADRS)
  • A standardized clinical interview on suicidal thoughts if the score on the above question is 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, Sweden

Location

Related Publications (1)

  • Kraepelien M, Schibbye R, Mansson K, Sundstrom C, Riggare S, Andersson G, Lindefors N, Svenningsson P, Kaldo V. Individually Tailored Internet-Based Cognitive-Behavioral Therapy for Daily Functioning in Patients with Parkinson's Disease: A Randomized Controlled Trial. J Parkinsons Dis. 2020;10(2):653-664. doi: 10.3233/JPD-191894.

    PMID: 32176657DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Viktor Kaldo, Ph. D

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Docent)

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 11, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

SE(1)