Clinical trial NCT02331537: Internet-based Exposure Therapy for Excessive Worry
Official title: Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Worry
Rumination
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.

Detailed description: Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.

Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.

Duration: Ten weeks

Primary Endpoint: Change in worry symptoms from baseline to Week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).

Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)

Safety Parameters: Adverse Events is assessed weekly via the internet.

Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points

Number of Subjects: 140

Eligibility criteria: Inclusion Criteria:

* Outpatients
* ≥ 18 years
* Situated in Sweden
* Informed consent
* Penn State Worry Questionnaire score more than 56 points

Exclusion Criteria:

* Substance dependence during the last six months
* Post traumatic stress disorder, bipolar disorder or psychosis
* Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
* MADRS-S score above 25 points
* Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
* Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years

Primary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Week 0, Week 10, Long term follow-up at 4-, and 12-months after treatment has ended
Secondary outcomes:
measure: Meta Cognitions Questionnaire (MCQ-30)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Euroqol (EQ-5D)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Spontaneous Use of Imagery Scale (SUIS)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Cognitive Avoidance Questionnaire (CAQ)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
measure: Intolerance of Uncertainty Scale (IUS)
timeFrame: Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik M Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: