CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 161 enrolled
Drug / intervention
Integrated GP Carebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02444520
NCT02444520N/ACompleted

Persistent Physical Symptoms Reduction Intervention: a Systems Change and Evaluation (PRINCE) - Integrated GP Care for Persistent Physical Symptoms: a Feasibility & Cluster Randomised Controlled Trial

King's College London·interventional·Posted May 14, 2015·Updated May 9, 2019

In Brief

A clinical study evaluating Integrated GP Care for Persistent Physical Symptoms. Completed, enrolled 161 participants across 1 site.

Detailed Summary

PRINCE primary is cluster randomised waiting list controlled trial to evaluate the feasibility of an integrated approach to care in general practice for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with no obvious underlying organic. 240 patients with PPS recruited from 8-12 GP practices in London will be randomised to the integrated care approach plus treatment as usual (TAU) or TAU alone. The integrated GP approach consists of providing GPs with a short cognitive behaviour therapy (CBT) skills training, ongoing supervision, as well as written and audio-visual materials/guidelines. In addition, participants randomised to the intervention group will receive tailored CBT-based self-help materials (i.e. written and audio-visual materials).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 14, 2015
Enrollment StartMay 1, 2015
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.1 years ago

Interventions

Integrated GP Carebehavioral

The overall aims of the intervention are to help the patient: 1. develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem; 2. understand factors that may be maintaining the problem; 3. learn how to modify the behavioral and cognitive responses which may be maintaining the problem; 4. adopt a healthy sleep routine which can promote healthy living. Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed.