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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615483
• Other study ID #: 654902
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2021
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Lumbar Spine Fusion

Intervention

Other:
• Web-based platform
The WP is based on a conducted literature review and results form a previous study conducted in the regional context of the study. Information on the WP is animated based on the current literature stating that educative animation video optimises patients' acquisition of knowledge. The intention is to offer the patients the advantages in gaining knowledge in familiar surroundings and at a pace matching their needs and wishes. The WP contains animated and written information mirroring the course of treatment, frequently asked questions and answers, it contains animated training support, a diary in order to keep track of training and development of pain and finally a social feature, a web-café.

Locations

Country	Name	City	State
Denmark	Centre og Elective Surgery, Regional Hospital Silkeborg	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and Depression	The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)	3 months after surgery
Secondary	Functional outcome	Oswestry Disability Index (ODI)	3, 6,12 months after surgery
Secondary	Self-perceived health status	EQ-5D	3, 6, 12 months after surgery
Secondary	Back and leg pain	Low Back Pain Rating Scale (LBPRS)	3, 6, 12 months after surgery
Secondary	Anxiety and Depression	HADS	6, 12 months after surgery