Clinical trial NCT02638792: Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry
Official title: Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Worry
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 311
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 more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.

Detailed description: Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome

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

Duration: Ten weeks

Primary Endpoint:

Difference in worry symptoms between the treatment groups at 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 via the internet.

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

Number of Subjects: 300

Eligibility criteria: Inclusion Criteria:

* Outpatients
* ≥ 18 years
* Situated in Sweden
* Informed consent
* PSWQ 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 CBT for pathological worry the last 2 years.

Primary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up.
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale (MADRS-S)
timeFrame: Week 0, Week 10, 4 and 12 months follow-up
measure: Euroqol, EQ-5D
timeFrame: Week 0, Week 10, 4 and 12 months follow-up
measure: Cognitive Avoidance Questionnaire (CAQ)
timeFrame: Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment
measure: Intolerance of uncertainty scale
timeFrame: Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment
measure: Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Week 0, Week 10, 4 and 12 months follow-up
measure: Brunnsviken Quality of Life Questionnaire (BBQ)
timeFrame: Week 0, Week 10, 4 and 12 months follow-up
measure: Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)
timeFrame: Week 0 - Week 10 (weekly measurements)
measure: The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness
timeFrame: Week 0 - Week 10 (weekly measurements)
measure: Patient Health Questionnaire-2
timeFrame: Week 0 - Week 10 (weekly measurements)
measure: Adverse Events
timeFrame: Week 3, week 8, week 10, 4 and 12 months follow-up
Other outcomes:
measure: Treatment credibility scale
timeFrame: Week 2
measure: Working alliance scale
timeFrame: Week 5
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Intitutet
Study officials:
affiliation: Karolinska Institutet
name: Erik M Andersson, PhD, Psych.
role: PRINCIPAL_INVESTIGATOR
References: