Patient-driven Internet Delivered Psychological Treatment

Vastra Gotaland Region

Status: Completed

Conditions: Anxiety Disorders and Symptoms; Internet-Based Intervention

Treatments: Behavioral: Patient-driven iCBT; Behavioral: Standardized iCBT (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT04688567

Dnr: 2019-03786

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Patient-driven iCBT

Experimental group

Description:

Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment program

Treatment:

Behavioral: Patient-driven iCBT

Standardized iCBT (TAU)

Active Comparator group

Description:

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

Treatment:

Behavioral: Standardized iCBT (TAU)