Peer-supported Internet Mediated Psychological Treatment

Peer-supported Internet Mediated Psychological Treatment for Adults With Anxiety Disorders in Primary Care

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

Study Overview

• Status: Completed
• Conditions: Mental Disorder; Behavior and Behavior Mechanisms; Psychological Phenomena and Processes; Behavioral Disciplines and Activities
• Intervention / Treatment: Behavioral: iCBT with addition of peer-support

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland Region
    • Borås, Västra Götaland Region, Sweden
      • Närhälsan, Primary care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iCBT with addition of peer-support (iCBT-PS); Participants in the iCBT-PS, are guided by both a psychologist and a peer-support in the iCBT-program used in the study.

Behavioral: iCBT with addition of peer-support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
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.	Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
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.	Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program
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.	Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Study Chair: Sandra Weineland, PhD, Department of Psychology, University of Gothenburg, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 25, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 25, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety; Primary Care; Drop-out; Peer-support; iCBT; Mixed method design
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: Drn EPN: 845-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will share the data if a corresponding author or otherwise authorized person asks for it
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No