Anxiety Disorders and SymptomsNCT04688567

Patient-driven Internet Delivered Psychological Treatment

A study testing Patient-driven iCBT and Standardized iCBT (TAU) in people with Anxiety Disorders and Symptoms and Internet-Based Intervention, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety Disorders and Symptoms, Internet-Based Intervention
What is being tested?: Patient-driven iCBT and Standardized iCBT (TAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteSweden
Study dates: 1 Nov 2019to 30 Mar 2021
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

Has reached the age of 18
Has access to a computer with internet connection
Speak and understand Swedish
Meets the diagnostic criteria for an anxiety disorder (social anxiety, GAD (Generalized Anxiety Disorder), panic disorder, obsessive-compulsive disorder or unspecified anxiety disorder)

Who cannot join

has started medication for mental illness or made major changes regarding the medication during the past 4 weeks
has serious suicidal thoughts or suicidal plans
has complex comorbidity or is in need of other care for mental illness in addition to iCBT
is receiving other psychological treatment during the treatment period

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Psychology, University of Gothenburg
Gothenburg

Other trials in Sweden

About this study

Official title: Patient-driven Internet Delivered Psychological Treatment in a Primary Care Context: a Randomized Controlled Trial

The effect of iCBT for adults with anxiety disorders is well-known. However, drop-out rates are common. In recent years more focus has been directed to the importance of patients being active agents in their own care and to increase the patient´s involvement in health care. Studies show that involving patients´ in treatment decisions and management of their own health care can contribute to better treatment outcomes and more appropriate use of health care service.

Few studies have evaluated patient involvement in iCBT-treatment. This study aims to evaluate the effect of patient-driven iCBT-treatment for patients with anxiety disorders seeking primary care in a randomized controlled trial. The study investigates the effect of patient-driven iCBT treatment of perceptions of being able to control the treatment and on drop-out from treatment. In addition, secondary research questions investigate measures of empowerment, anxiety and depression symptoms, general disability, satisfaction with treatment and feelings of being able to cope with one's mental illness in patient-driven iCBT.

Read the detailed description

The following research questions will be examined:

Primary research questions:

Is there a difference between participants in patient-driven digital psychological treatment, compared to standardized internet CBT, in perceptions of how much they've been able to control their treatment (measured with a questionnaire developed by the researchers for this study)?
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on frequency of completers and completed modules among adults with anxiety disorders? Secondary research questions:
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on the experience of empowerment, (measured by the "Empowerment Scale"), for adults with anxiety disorders?
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on anxiety (measured with GAD-7), depression (measured with MADRS-S), general disability (measured with WHODAS 2.0) and steps in "valued direction" (measured with "Bull´s Eye compass") for adults with anxiety disorders? Associations:
Is there a correlation between perceptions of how much one has been able to control the treatment (measured with a questionnaire developed by the researchers for this study), feelings of being able to cope with one's mental illness (measured with Patient Enablement Instrument), how satisfied participants are with their treatment (measured vid CSQ-8), perceptions of empowerment (measured with the "Empowerment Scale") and changes in anxiety symptoms (measured with GAD-7)?
Does perceptions of how much participants have been affected by the pandemic of Covid-19 in their daily life correlate with anxiety symptoms (measured with GAD-7) 3 months after termination of treatment? Mediation:
What is the mediating effect of empowerment, measured by the "Empowerment Scale", on changes in anxiety symptoms (measured with GAD-7)?

Conditions: Anxiety Disorders and Symptoms, Internet-Based Intervention
Being tested: Patient-driven iCBT, Standardized iCBT (TAU)
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient-driven iCBTBehavioural
1. Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment by the time of the randomization call. The participant can choose which of the available treatment programs (targeting anxiety, worry, stress, sleep disorders or depression) they want to undergo, how many modules in the treatment program they want to complete and in what order, for how many weeks they want to complete the treatment as well as how much telephone contact and how much written contact they want to have with their therapist.
Standardized iCBT (TAU)Behavioural
1. Patients who are randomized to the control condition (standardized iCBT) undergo the usual iCBT program available for anxiety disorders for 8 weeks. The psychologist provide weekly feedback on the patient's exercises and interact with the patient via secure encrypted messages in the treatment program. A follow-up telephone call takes place at the middle of treatment and at the end of the treatment.

Study groups in NCT04688567
Study group	Role	What they receive
Patient-driven iCBT	Experimental	Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment program Receives: Behavioral: Patient-driven iCBT
Standardized iCBT (TAU)	Active comparator	Patients who are randomized to the control condition undergo the usual iCBT program available for anxiety disorders for a standardized time period of 8 weeks Receives: Behavioral: Standardized iCBT (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

Questions of perceptions in how much one has been able to control the treatment
Perceptions in how much one has been able to control the treatment is measured by a questionnaire developed by the researchers for this study. The questionnaire consists of 9 items and each item is answered on a seven-point scale, from "Not at all" to "To a large extent".
Measured: At the end of treatment (after 8-16 weeks depending on treatment condition)
Adherence to treatment
Adherence to treatment is measured by counting number of completed modules in the treatment program for each participant
Measured: At the end of treatment (after 8-16 weeks depending on treatment condition)

Secondary outcomes (8)

Changes in feelings of empowerment
Empowerment is measured with the Empowerment Scale (Rogers, Chamberlin, Ellison \& Crean, 1997). The scale consists of 28 items which are answered on a four-point likert scale. Score ranges between 28 and 112. Higher scores indicates that the person feels more empowered.
Measured: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Perceptions of being able to cope with one's mental illness
Perceptions of being able to cope with one's mental illness is measured with the Patient Enablement Instrument (PEI; Howie, Heaney \& Maxwell, 1997). The instrument consists of 6 items and are graded on a three-point scale. Score ranges between 0-12, with higher score indicating higher patient enablement.
Measured: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Satisfaction with treatment
Satisfaction with treatment is measured by The Client Satisfaction Questionnaire- 8 item version (CSQ-8; Attkisson \& Greenfield, 1998). The questionnaire consists of 8 items and are graded on a four-point scale. Scores ranges from 8-32, with higher scores indicating higher satisfaction.
Measured: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in Anxiety symptoms
Anxiety is measured with the GAD-7 instrument (Generalized Anxiety Disorder 7 item scale). The scale consists of 7 items. The score ranges from 0 to 21, with higher scores indicating more anxiety symptoms. There are thresholds for mild, medium and severe anxiety (Spitzer, Kroenke, Williams \& Löwe 2006).
Measured: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in Depressive symptoms
Symptoms of depression is measured with Madrs-s (Montgomery Åsberg Depression Rating Scale; Montgomery \& Åsberg, 1979). The instrument consists of 9 items. Scores ranges from 0 to 60, with higher scores indicating more depressive symptoms. There are cut-off points for symptom severity.
Measured: Baseline (Pre-treatment), middle of treatment, At the end of treatment (after 8-16 weeks depending on the treatment condition) and by 3 months follow up
Changes in General disabillity
General disability is measured with the 12-item version of the generic assessment tool WHO Disability Assessment Schedule (WHODAS 2.0; Rhem, Ustun, Saxena, Nelson, Chatterji, Ivis \& Adlaf, 1999). Scores range from 12-60, with a higher score indicating higher disability. The instrument has established normative data.
Measured: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in steps towards "valued direction"
Steps towards "valued direction" is measured with "the Bull´s Eye Values Survey" (Lundgren, Louma, Dahl, Strohsal \& Melin, 2012).
Measured: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
10. Questions about how much one has been affected by the pandemic of Covid-19
Perceptions about how much one has been affected by the pandemic of Covid-19 is measured by a questionnaire developed by the researchers for this study. The questionnaire consists of 7 items that is answered on a seven-point scale. 1 indicating= To a very large extent for the worse; 4= not at all / not relevant; 7= to a very large extent for the better.
Measured: By 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201930 Mar 2021

First posted30 Dec 2020
Study start1 Nov 2019
Primary completion30 Mar 2021
Study completion30 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
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: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04688567
Sponsor's protocol ID: Dnr: 2019-03786
Status last verified: Apr 2023
First submitted: 17 Dec 2020
Last updated: 1 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share the data if a corresponding author or otherwise authorized person asks for it

Publications

Nissling L, Kraepelien M, Kaldo V, Hange D, Larsson A, Persson M, Weineland S. Effects of patient-driven iCBT for anxiety in routine primary care and the relation between increased experience of empowerment and outcome: A randomized controlled trial. Internet Interv. 2021 Sep 21;26:100456. doi: 10.1016/j.invent.2021.100456. eCollection 2021 Dec.
PubMed 34603972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-driven Internet Delivered Psychological Treatment in a Primary Care Context: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04688567
Acronym / sponsor ID: Dnr: 2019-03786
Conditions: Anxiety Disorders and Symptoms, Internet-Based Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Vastra Gotaland RegionOther government
Study start: 1 Nov 2019 (actual)
Primary completion: 30 Mar 2021 (actual)
Study completion: 30 Mar 2021 (actual)
First posted: 30 Dec 2020 (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.

Detailed description

The following research questions will be examined:

Primary research questions:

Is there a difference between participants in patient-driven digital psychological treatment, compared to standardized internet CBT, in perceptions of how much they've been able to control their treatment (measured with a questionnaire developed by the researchers for this study)?
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on frequency of completers and completed modules among adults with anxiety disorders? Secondary research questions:
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on the experience of empowerment, (measured by the "Empowerment Scale"), for adults with anxiety disorders?
What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on anxiety (measured with GAD-7), depression (measured with MADRS-S), general disability (measured with WHODAS 2.0) and steps in "valued direction" (measured with "Bull´s Eye compass") for adults with anxiety disorders? Associations:
Is there a correlation between perceptions of how much one has been able to control the treatment (measured with a questionnaire developed by the researchers for this study), feelings of being able to cope with one's mental illness (measured with Patient Enablement Instrument), how satisfied participants are with their treatment (measured vid CSQ-8), perceptions of empowerment (measured with the "Empowerment Scale") and changes in anxiety symptoms (measured with GAD-7)?
Does perceptions of how much participants have been affected by the pandemic of Covid-19 in their daily life correlate with anxiety symptoms (measured with GAD-7) 3 months after termination of treatment? Mediation:
What is the mediating effect of empowerment, measured by the "Empowerment Scale", on changes in anxiety symptoms (measured with GAD-7)?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Patient-driven iCBT	Experimental	Behavioral: Patient-driven iCBTParticipants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment program
Standardized iCBT (TAU)	Active comparator	Behavioral: Standardized iCBT (TAU)Patients who are randomized to the control condition undergo the usual iCBT program available for anxiety disorders for a standardized time period of 8 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Has reached the age of 18
Has access to a computer with internet connection
Speak and understand Swedish
Meets the diagnostic criteria for an anxiety disorder (social anxiety, GAD (Generalized Anxiety Disorder), panic disorder, obsessive-compulsive disorder or unspecified anxiety disorder)

Key exclusion criteria (4 listed)

has started medication for mental illness or made major changes regarding the medication during the past 4 weeks
has serious suicidal thoughts or suicidal plans
has complex comorbidity or is in need of other care for mental illness in addition to iCBT
is receiving other psychological treatment during the treatment period

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
Patient-driven iCBT1) Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment by the time of the randomization call. The participant can choose which of the available treatment programs (targeting anxiety, worry, stress, sleep disorders or depression) they want to undergo, how many modules in the treatment program they want to complete and in what order, for how many weeks they want to complete the treatment as well as how much telephone contact and how much written contact they want to have with their therapist.	Behavioural	Patient-driven iCBT
Standardized iCBT (TAU)2) Patients who are randomized to the control condition (standardized iCBT) undergo the usual iCBT program available for anxiety disorders for 8 weeks. The psychologist provide weekly feedback on the patient's exercises and interact with the patient via secure encrypted messages in the treatment program. A follow-up telephone call takes place at the middle of treatment and at the end of the treatment.	Behavioural	Standardized iCBT (TAU)

Primary outcome

Questions of perceptions in how much one has been able to control the treatment
Time frame: At the end of treatment (after 8-16 weeks depending on treatment condition)
Perceptions in how much one has been able to control the treatment is measured by a questionnaire developed by the researchers for this study. The questionnaire consists of 9 items and each item is answered on a seven-point scale, from "Not at all" to "To a large extent".
Adherence to treatment
Time frame: At the end of treatment (after 8-16 weeks depending on treatment condition)
Adherence to treatment is measured by counting number of completed modules in the treatment program for each participant

8 secondary outcomes

Changes in feelings of empowerment
Time frame: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Perceptions of being able to cope with one's mental illness
Time frame: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Satisfaction with treatment
Time frame: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in Anxiety symptoms
Time frame: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in Depressive symptoms
Time frame: Baseline (Pre-treatment), middle of treatment, At the end of treatment (after 8-16 weeks depending on the treatment condition) and by 3 months follow up
Changes in General disabillity
Time frame: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
Changes in steps towards "valued direction"
Time frame: Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
10. Questions about how much one has been affected by the pandemic of Covid-19
Time frame: By 3 months follow up

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 1 May 2023.
Derived from this study: PubMed 34603972Nissling L, Kraepelien M, Kaldo V, Hange D, Larsson A, Persson M, Weineland S. Effects of patient-driven iCBT for anxiety in routine primary care and the relation between increased experience of empowerment and outcome: A randomized controlled trial. Internet Interv. 2021 Sep 21;26:100456. doi: 10.1016/j.invent.2021.100456. eCollection 2021 Dec.
Individual participant dataSharing planned: Yes. We will share the data if a corresponding author or otherwise authorized person asks for it

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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.

Linnea Nissling, Phd-student principal investigator

Department of Psychology, University of Gothenburg, Sweden

Martin Kraepelien, PhD study director

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Sweden

Viktor Kaldo, Professor study director

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Patient-driven iCBT and Standardized iCBT (TAU) in people with Anxiety Disorders and Symptoms and Internet-Based Intervention, run by Vastra Gotaland Region 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 4 inclusion and 4 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 1 May 2023. 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?

Questions of perceptions in how much one has been able to control the treatment (time frame: At the end of treatment (after 8-16 weeks depending on treatment condition)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688567, which also lists 1 linked publication.

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 1 May 2023.