Clinical trial NCT04688567: Patient-driven Internet Delivered Psychological Treatment
Official title: Patient-driven Internet Delivered Psychological Treatment in a Primary Care Context: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Internet-Based Intervention
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-12-30
Enrollment: 56
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 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.

Detailed description: The following research questions will be examined:

Primary research questions:

1. 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)?
2. 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:
3. 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?
4. 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:
5. 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)?
6. 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:
7. What is the mediating effect of empowerment, measured by the "Empowerment Scale", on changes in anxiety symptoms (measured with GAD-7)?

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Questions of perceptions in how much one has been able to control the treatment
timeFrame: At the end of treatment (after 8-16 weeks depending on treatment condition)
measure: Adherence to treatment
timeFrame: At the end of treatment (after 8-16 weeks depending on treatment condition)
Secondary outcomes:
measure: Changes in feelings of empowerment
timeFrame: 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
measure: Perceptions of being able to cope with one's mental illness
timeFrame: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
measure: Satisfaction with treatment
timeFrame: At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up
measure: Changes in Anxiety symptoms
timeFrame: 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
measure: Changes in Depressive symptoms
timeFrame: 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
measure: Changes in General disabillity
timeFrame: 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
measure: Changes in steps towards "valued direction"
timeFrame: 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
measure: 10. Questions about how much one has been affected by the pandemic of Covid-19
timeFrame: By 3 months follow up
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Psychology, University of Gothenburg
Study officials:
affiliation: Department of Psychology, University of Gothenburg, Sweden
name: Linnea Nissling, Phd-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Sweden
name: Martin Kraepelien, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Sweden
name: Viktor Kaldo, Professor
role: STUDY_DIRECTOR
affiliation: General Medicine, School of Public Health and Community Medicine, Sahlgrenska Academy, Sweden
name: Dominique Hange, Docent
role: STUDY_DIRECTOR
affiliation: Research, Development, Education and Innovation, Primary Health Care, Region Västra Götaland,Sweden
name: Anna Larsson, Psy M
role: STUDY_DIRECTOR
affiliation: Department of Psychology, University of Gothenburg, Sweden
name: Sandra Weineland, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.