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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02615483
Enrollment
114
Registered
2015-11-26
Start date
2015-11-30
Completion date
2019-03-31
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Lumbar Spine Fusion

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.

Interventions

OTHERWeb-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.

Sponsors

Central Jutland Regional Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety and Depression3 months after surgeryThe change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)

Secondary

MeasureTime frameDescription
Functional outcome3, 6,12 months after surgeryOswestry Disability Index (ODI)
Self-perceived health status3, 6, 12 months after surgeryEQ-5D
Back and leg pain3, 6, 12 months after surgeryLow Back Pain Rating Scale (LBPRS)
Anxiety and Depression6, 12 months after surgeryHADS

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026