Patient-driven Internet Delivered Psychological Treatment

NCT ID: NCT04688567

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-03-30

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)?

Conditions

Anxiety Disorders and Symptoms; Internet-Based Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient-driven iCBT

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

Group Type: EXPERIMENTAL

Patient-driven iCBT

Intervention Type: BEHAVIORAL

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)

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

Group Type: ACTIVE_COMPARATOR

Standardized iCBT (TAU)

Intervention Type: BEHAVIORAL

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.

Interventions

Patient-driven iCBT

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linnea Nissling, Phd-student

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Gothenburg, Sweden

Martin Kraepelien, PhD

Role: STUDY_DIRECTOR

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

Viktor Kaldo, Professor

Role: STUDY_DIRECTOR

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

Dominique Hange, Docent

Role: STUDY_DIRECTOR

General Medicine, School of Public Health and Community Medicine, Sahlgrenska Academy, Sweden

Anna Larsson, Psy M

Role: STUDY_DIRECTOR

Research, Development, Education and Innovation, Primary Health Care, Region Västra Götaland,Sweden

Sandra Weineland, Docent

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Gothenburg, Sweden

Locations

Department of Psychology, University of Gothenburg

Gothenburg, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34603972 (View on PubMed)

Other Identifiers

Dnr: 2019-03786

Identifier Type: -

Identifier Source: org_study_id