Internet-CBT for Parkinsons Disease

Parkinson Disease Clinical Trial

— Patrik  

Official title:

Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627885
• Other study ID #: 2015/1938-31/4
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: January 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Internet-based Cognitive Behavioral Therapy (ICBT) will be given as an adjunct to the Standard Medical Treatment. ICBT will be compared to Standard Medical Treatment alone (SMT).

A secondary aim is make a preliminary evaluation of the ICBT-program with less and less active therapist support. It is hypothesized that both active treatments will be superior to SMT in improving quality of life and functioning and that ICBT with full therapist support will be superior to ICBT with lower level of therapist support.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed Parkinson disease

• WSAS score of over 17

• Access to a internet connected device and a mobile phone capable of receiving SMS

Exclusion Criteria:

• 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:

• 5 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Internet-based CBT
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.

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

Locations

Country	Name	City	State
Sweden	Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (self-rated)		5 weeks (Mid) and 10 weeks (Post)
Other	Adverse Events (therapist-rated)	Therapist use data from treatment to rate occurrences of Adverse events	5 weeks (Mid) and 10 weeks (Post)
Other	Adverse Events (interviewer-rated)	Blind assessor asks about Adverse Events during whole treatment	10 weeks (Post)
Other	Client Satisfaction	Client Satisfaction Questionnaire-8	10 weeks (Post)
Other	Clinical Global Impression - Severity scale		10 weeks (Post)
Other	Clinical Global Impression - Improvement scale		10 weeks (Post)
Other	Use of other treatments	Use of other treatments during treatment period, self-rated	10 weeks (Post)
Primary	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	Change (from baseline) in IPAQ	International Physical Activity Questionnaire. Self-administered, measures physical activity	Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in SVAQ	Swedish Valued Activity Questionnaire. Self-administered, measures valued activities	Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in WHODAS-2	World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability	Baseline, 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in PDQ-8	Parkinson's Disease Questionnaire-8. Self-administered, measures functioning and well-being patients with Parkinsons disease	Baseline, 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in BBQ	Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life	Baseline, 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in HADS	The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.	Baseline, 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in ISI	Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems	Baseline, 10 weeks (Post) and up to 2 (FU) measures
Secondary	Change (from baseline) in SSES6	Stanford Self-Efficacy for Managing Chronic Disease. Self-administered, measures self efficacy in relation to a chronic disease	Baseline, 10 weeks (Post) and up to 2 (FU) measures