Patient-driven Internet Delivered Psychological Treatment

NCT04688567 | Completed

• 1 other identifier: Dnr: 2019-03786
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders and Symptoms; Internet-Based Intervention

Outcome Measures

Primary Outcomes (2)

• 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".

  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

  At the end of treatment (after 8-16 weeks depending on treatment condition)

Secondary Outcomes (8)

• Changes in feelings of empowerment

  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

  At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up

• Satisfaction with treatment

  At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up

• Changes in Anxiety symptoms

  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

  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

Study Arms (2)

Patient-driven iCBT

EXPERIMENTAL

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

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

Behavioral: Standardized iCBT (TAU)

Interventions

Patient-driven iCBT 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.

Patient-driven iCBT

Standardized iCBT (TAU) 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.

Standardized iCBT (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Department of Psychology, University of Gothenburg

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34603972 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Linnea Nissling, Phd-student

  Department of Psychology, University of Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

• Martin Kraepelien, PhD

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

  STUDY DIRECTOR

• Viktor Kaldo, Professor

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

  STUDY DIRECTOR

• Dominique Hange, Docent

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

  STUDY DIRECTOR

• Anna Larsson, Psy M

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

  STUDY DIRECTOR

• Sandra Weineland, Docent

  Department of Psychology, University of Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The groups are predetermined based on the tool randomizer.org and blinded to the researcher assigning the participants to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 30, 2020
• Study Start: November 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)