Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression

Not Applicable

Completed

• Conditions: Anxiety; Depression; Lumbar Spine Fusion
• Interventions: Other: Web-based platform

• Registration Number: NCT02615483
• Lead Sponsor: Central Jutland Regional Hospital

Brief Summary

The purpose of the present study is to investigate the effect of a Web- based Platform (WP) on anxiety and depression and health economics among patients undergoing lumbar spine fusion (LSF).

Detailed Description

This study will seek to reduce pre- and postoperative anxiety, depression and functional impairments using alternative cognitive and educative methods, targeting the underlying factors for development of anxiety and depression.

It is known that there is a rationale behind using Cognitive Behavioural Therapy (CBT) in order to reduce pre- and postoperatively anxiety and depression. The main assumption within CBT is that patients´ perceptions create their thoughts and beliefs, which influence their feelings and subsequently their behaviour. The features of WP in this study will seek in several ways to exceed this expected behaviour modification. The preliminary choices of features on the WP are made in order to prevent catastrophic images and thereby reduce anxiety and depression. The WP will offer patients non-catastrophic images through animated information mirroring the course of treatment, which will aim to influence their beliefs, feelings and their behaviour.

To examine the effect of the WP versus conventional information and course of rehabilitation, on patients' degree of anxiety and depression, a randomized controlled trial will be preformed. A total of 114 patients scheduled for elective instrumented LSF will be included and randomly assigned to the control group or to the intervention group receiving access to the WP.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Primary Completion: 2018-08
• Study Completion: 2019-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion

Exclusion Criteria

• Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based platform	Web-based platform	Access to a web-based platform

Primary Outcome Measures

Name	Time	Method
Anxiety and Depression	3 months after surgery	The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)

Secondary Outcome Measures

Name	Time	Method
Functional outcome	3, 6,12 months after surgery	Oswestry Disability Index (ODI)
Back and leg pain	3, 6, 12 months after surgery	Low Back Pain Rating Scale (LBPRS)
Anxiety and Depression	6, 12 months after surgery	HADS
Self-perceived health status	3, 6, 12 months after surgery	EQ-5D

Trial Locations

Locations (1)

Centre og Elective Surgery, Regional Hospital Silkeborg; 🇩🇰 Silkeborg, Denmark