Peer-supported Internet Mediated Psychological Treatment
Primary Purpose
Psychological Phenomena and Processes, Behavior and Behavior Mechanisms, Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
iCBT with addition of peer-support
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Phenomena and Processes focused on measuring iCBT, Primary Care, Anxiety, Drop-out, Peer-support, Mixed method design
Eligibility Criteria
Inclusion Criteria:
- participants must have reached the age of 18
- have access to a computer with internet Connection
- speak and understand Swedish
- meet the diagnostic criteria for an anxiety disorder (social anxiety, GAD, panic disorder, obsessive-compulsive disorder, or unspecified anxiety disorder).
Exclusion Criteria:
- have started medication or have made major changes regarding their medication in the past few months
- have serious suicidal ideation or suicide plans
- are expected to have complex problems or be in need of other care
- are under any other psychological treatment during the time of the treatment period.
Sites / Locations
- Närhälsan, Primary care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iCBT with addition of peer-support (iCBT-PS)
Arm Description
Participants in the iCBT-PS, are guided by both a psychologist and a peer-support in the iCBT-program used in the study.
Outcomes
Primary Outcome Measures
Change 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).
Change 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.
Change in symptoms of psychological distress
Symptoms of psychological distress is measured with the CORE-10 (Barkham et al., 2012). Score ranges from 0 to 40, with higher scores indicating more psychological distress. The instrument consists of 10 items and has clinical cut-off scores for general psychological distress.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04244617
First Posted
January 20, 2020
Last Updated
January 25, 2020
Sponsor
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT04244617
Brief Title
Peer-supported Internet Mediated Psychological Treatment
Official Title
Peer-supported Internet Mediated Psychological Treatment for Adults With Anxiety Disorders in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the effect and experience of peer-support in internet mediated ACT (Acceptance and Commitment therapy) in an explorative pilot study with mixed method design conducted in primary care. Peer-supporters are certified support persons with personal experience of mental health problems and the process of rehabilitation, which becomes professionally active in care and support to patients in their recovery
Detailed Description
The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews in order to investigate the participant´s experience of treatment. Participants were recruited from patients who were referred to a central unit for internet- CBT (Cognitive Behavioral therapy) in primary care in Västra Götaland region, Sweden. Peer-supporters were recruited through a swedish patient organization. Participants were adults 18 years of age or older with an anxiety disorder.
All participants were interviewed by a psychologist with a diagnostic instrument, a structured interview called PRIME-MD, before starting treatment. After the interview, all patients who were offered iCBT and met the inclusion criteria were requested to participate in the study.
Patients who accepted inclusion were guided by both a psychologist and a peer-support in the iCBT treatment used in the study. The iCBT treatment program used is a transdiagnostic program aimed at treating people with mild to moderate anxiety problems.
Quantitative data about psychosocial symptoms were collected, and qualitative data about the participants experience of treatment were collected through semi-structured interviews.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Phenomena and Processes, Behavior and Behavior Mechanisms, Mental Disorder, Behavioral Disciplines and Activities
Keywords
iCBT, Primary Care, Anxiety, Drop-out, Peer-support, Mixed method design
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCBT with addition of peer-support (iCBT-PS)
Arm Type
Experimental
Arm Description
Participants in the iCBT-PS, are guided by both a psychologist and a peer-support in the iCBT-program used in the study.
Intervention Type
Behavioral
Intervention Name(s)
iCBT with addition of peer-support
Intervention Description
Peer-supporters and participants, as well as psychologists and participants, interact in the treatment program via asynchronous secure messages. Peer-supporters are able to give support and feedback on exercises. A reconciliation call via telephone is entered into the middle of the treatment and a follow-up call after completion of treatment conducted by the peer-support. The interaction between peer-supporters and participants is tracked by the psychologist.
Primary Outcome Measure Information:
Title
Change in Anxiety symptoms
Description
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).
Time Frame
Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Title
Change in Depressive symptoms
Description
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.
Time Frame
Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Title
Change in symptoms of psychological distress
Description
Symptoms of psychological distress is measured with the CORE-10 (Barkham et al., 2012). Score ranges from 0 to 40, with higher scores indicating more psychological distress. The instrument consists of 10 items and has clinical cut-off scores for general psychological distress.
Time Frame
Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program
Title
Changes in feelings of empowerment
Description
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.
Time Frame
Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participants must have reached the age of 18
have access to a computer with internet Connection
speak and understand Swedish
meet the diagnostic criteria for an anxiety disorder (social anxiety, GAD, panic disorder, obsessive-compulsive disorder, or unspecified anxiety disorder).
Exclusion Criteria:
have started medication or have made major changes regarding their medication in the past few months
have serious suicidal ideation or suicide plans
are expected to have complex problems or be in need of other care
are under any other psychological treatment during the time of the treatment period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Weineland, PhD
Organizational Affiliation
Department of psychology, University of Gothenburg, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Närhälsan, Primary care
City
Borås
State/Province
Västra Götaland Region
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share the data if a corresponding author or otherwise authorized person asks for it
Learn more about this trial
Peer-supported Internet Mediated Psychological Treatment
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