Clinical trial NCT03807193: Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support
Official title: Self-selected or Predetermined Internet-based Cognitive Behavior Therapy for Generalized Anxiety Disorder With Weekly Support or Support on Demand: A Factorial Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Worry
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2019-01-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial design with four cells:

Cell one: Predetermined treatment program with weekly support Cell two: Predetermined treatment program with support on demand Cell three: Self-selected treatment program with weekly support Cell four: Self-selected treatment program with support on demand
Primary purpose: TREATMENT

Brief summary: This study evaluates two types of internet-based treatments for generalized anxiety disorder and two types of support. The treatments are a predetermined program for generalized anxiety disorder and a self-selected treatment. The different types of support are either a weekly contact trough a secure message system or support on demand.

Detailed description: Generalized anxiety disorder (GAD) is characterize by and excessive and uncontrollable worry that is present more days than not. The disorder is best described as a chronic condition with periods with more or less symptoms. The disorder is highly disabling with low quality of life for the individual and is associated with and high costs for society. Previous studies on internet-based cognitive behavior therapy for GAD has shown positive effects but there are still room for improvement.

The aim of this study is to evaluate two different internet-based treatments as well as two types of support through the use of a factorial design. The participants will be recruited trough advertising. After registration on the study's website the potential participants will be asked to answer screening questionnaires and demographic data for an initial screening. Those meeting inclusion criteria will be contacted for a diagnostic interview based Mini-International Neuropsychiatric Interview (M.I.N.I.). If meeting the study's inclusion criteria and not the exclusion criteria the participant will be included in the study and randomized to one of the four arms. The four arms are: Predetermined treatment program with weekly support, Predetermined treatment program with support on demand, Self-selected treatment with weekly support, Self-selected treatment with support on demand.

The predetermined treatment program is designed for treatment of worry and generalized anxiety disorder. It is based on newer forms of cognitive behavior therapy and includes mindfulness and acceptance. In the self-selected treatment the participants will select treatment interventions with the help of a manual and encouraged to choose interventions that they feel address their specific problems. The interventions that will be available are all based on standard cognitive behavior therapy techniques. The weekly support will be scheduled and delivered by clinical psychology students under supervision. This contact will be based on reports from the participants on the weeks work with the program and exercises. The support on demand will be also be delivered by clinical psychology students under supervision. This support takes place if and when the participant ask for support. Treatment will be 8 weeks long and both treatments will be delivered through the same platform. Contact with the participants will be trough written messages on a secure platform.

After the eight weeks of treatment the participants will be asked to answer the same measures as before the treatment as well as questions regarding how they experience the treatment. Follow up data will be collected at later points.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* fulfilling criteria for generalized anxiety syndrome
* 45 points or more on PSWQ
* Able to read and write in Swedish
* Have daily access to a computer and internet

Exclusion Criteria:

* Alcohol or substance abuse
* Acute suicidal
* Ongoing psychological treatment
* Ongoing medication for anxiety or depression that is planned to be adjusted during the time of the treatment given in the study
* Complex psychiatric illness that highly disabling

Primary outcomes:
measure: Change from baseline in Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
Secondary outcomes:
measure: Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
measure: Change from baseline in Beck Anxiety Inventory (BAI)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
measure: Beck Depression II Inventory (BDI-II)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
measure: Acceptance and Action Questionnaire II (AAQ-II)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
measure: General self-efficacy scale
timeFrame: Baseline, 8 weeks, 24 months and 36 months after treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköpings universitet
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: PRINCIPAL_INVESTIGATOR
References: