Generalized Anxiety DisorderNCT03807193
Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support
A study testing Self-selected treatment, Predetermined treatment and Weekly support in people with Generalized Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Self-selected treatment, Predetermined treatment and Weekly support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- 12 Feb 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Self-selected treatment, Predetermined treatment, Weekly support, Support on demand
- Keywords
- Worry
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-selected treatmentBehavioural
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 treatmentBehavioural
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 supportBehavioural
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 demandBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed treatment, weekly support | Experimental | Receives a predetermined treatment program and have weekly support. Receives: Behavioral: Predetermined treatment; Behavioral: Weekly support |
| Fixed treatment, support on demand | Experimental | Receives a predetermined treatment program and have access to support on demand. Receives: Behavioral: Predetermined treatment; Behavioral: Support on demand |
| Selected treatment, weekly support | Experimental | Select their own treatment material and have weekly support. Receives: Behavioral: Self-selected treatment; Behavioral: Weekly support |
| Selected treatment, support on demand | Experimental | Select their own treatment material and have access to support on demand. Receives: Behavioral: Self-selected treatment; Behavioral: Support on demand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Secondary outcomes (8)
Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
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
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity
Measured: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Change from baseline in Beck Anxiety Inventory (BAI)
Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Change from baseline in Patient Health Questionnaire (PHQ-9)
Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity
Measured: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
Beck Depression II Inventory (BDI-II)
Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Acceptance and Action Questionnaire II (AAQ-II)
Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Brunnsviken Brief Quality of life scale (BBQ)
12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
General self-efficacy scale
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.
Measured: Baseline, 8 weeks, 24 months and 36 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start12 Feb 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807193
- Sponsor's protocol ID
- worry factorial
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03807193
- Acronym / sponsor ID
- worry factorial
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Fixed treatment, weekly support | Experimental | Behavioral: Predetermined treatment, Behavioral: Weekly supportReceives a predetermined treatment program and have weekly support. |
| Fixed treatment, support on demand | Experimental | Behavioral: Predetermined treatment, Behavioral: Support on demandReceives a predetermined treatment program and have access to support on demand. |
| Selected treatment, weekly support | Experimental | Behavioral: Self-selected treatment, Behavioral: Weekly supportSelect their own treatment material and have weekly support. |
| Selected treatment, support on demand | Experimental | Behavioral: Self-selected treatment, Behavioral: Support on demandSelect their own treatment material and have access to support on demand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-selected treatmentThe 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. | Behavioural | Selected treatment, support on demand, Selected treatment, weekly support |
| Predetermined treatmentThe 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. | Behavioural | Fixed treatment, support on demand, Fixed treatment, weekly support |
| Weekly supportThe participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology. | Behavioural | Fixed treatment, weekly support, Selected treatment, weekly support |
| Support on demandThe 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. | Behavioural | Fixed treatment, support on demand, Selected treatment, support on demand |
Primary outcome
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
8 secondary outcomes
Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
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
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
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
Beck Depression II Inventory (BDI-II)
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Acceptance and Action Questionnaire II (AAQ-II)
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
General self-efficacy scale
Time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-selected treatment, Predetermined treatment and Weekly support in people with Generalized Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Penn State Worry Questionnaire (PSWQ) (time frame: Baseline, 8 weeks, 24 months and 36 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.