Peer-supported Internet Mediated Psychological Treatment

Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244617
• Other study ID #: Drn EPN: 845-18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Behavioral Disciplines and Activities
• Mental Disorder
• Mental Disorders
• Psychological Phenomena and Processes

Intervention

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.

Locations

Country	Name	City	State
Sweden	Närhälsan, Primary care	Borås	Västra Götaland Region

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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