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

Karolinska Institute

Status and phase: Completed; Phase 3

Conditions: Insomnia; Parkinson's Disease; Depression; Anxiety

Treatments: Behavioral: ICBT; Behavioral: ICONTROL

Study type: Interventional

Funder types: Other

Identifiers

NCT01545414

ICBT Parkinson

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

ICBT

Experimental group

Description:

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

Treatment:

Behavioral: ICBT

ICONTROL

Active Comparator group

Description:

Internet-based treatment with a focus on relaxation training

Treatment:

Behavioral: ICONTROL

SMT

No Intervention group

Description:

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