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NCT Number: NCT04244617

Peer-supported Internet Mediated Psychological Treatment

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

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Key information

Conditions

Psychological Phenomena and Processes Anxiety Disorders Behavior Behavior and Behavior Mechanisms Behavioral Disciplines and Activities Mental Disorder Mental Disorders Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Närhälsan, Primary care

Borås, Västra Götaland County, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Anxiety symptoms

    Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

    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).

  2. Change in Depressive symptoms

    Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

    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.

  3. Change in symptoms of 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

    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.

  4. Changes in feelings of empowerment

    Time frame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

    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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2020
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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