Skip to main content
OpenTrials
Completed

NCT Number: NCT03807193

Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköpings universitet

Linköping, Östergötland County, 58183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-selected treatment

Behavioral

The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.

Predetermined treatment

Behavioral

The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.

Weekly support

Behavioral

The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.

Support on demand

Behavioral

The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.

Primary outcomes

  1. Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms

Secondary outcomes

  1. Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity

  2. Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment

    Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity

  3. Change from baseline in Beck Anxiety Inventory (BAI)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity

  4. Change from baseline in Patient Health Questionnaire (PHQ-9)

    Time frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment

    Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity

  5. Beck Depression II Inventory (BDI-II)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity

  6. Acceptance and Action Questionnaire II (AAQ-II)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility

  7. Brunnsviken Brief Quality of life scale (BBQ)

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life

  8. General self-efficacy scale

    Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment

    Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.