Peer-supported Internet Mediated Psychological Treatment

NCT04244617 | Completed

• 1 other identifier: Drn EPN: 845-18
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

iCBT with addition of peer-support (iCBT-PS)

EXPERIMENTAL

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

Interventions

iCBT with addition of peer-support BEHAVIORAL

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.

iCBT with addition of peer-support (iCBT-PS)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Närhälsan, Primary care

Borås, Västra Götaland County, Sweden

Location

MeSH Terms

Conditions

Behavior; Mental Disorders; Motor Activity; Anxiety Disorders

Study Officials

• Sandra Weineland, PhD

  Department of psychology, University of Gothenburg, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: March 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

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

Locations

SE (1)