Clinical trial NCT04244617: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-01-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Anxiety symptoms
timeFrame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
measure: Change in Depressive symptoms
timeFrame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
measure: Change in symptoms of psychological distress
timeFrame: Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program
measure: Changes in feelings of empowerment
timeFrame: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Närhälsan, Primary care
state: Västra Götaland Region
Study officials:
affiliation: Department of psychology, University of Gothenburg, Sweden
name: Sandra Weineland, PhD
role: STUDY_CHAIR
References: