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Completed

NCT Number: NCT02615483

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre og Elective Surgery, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web-based platform

Other

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.

Primary outcomes

  1. Anxiety and Depression

    Time frame: 3 months after surgery

    The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)

Secondary outcomes

  1. Functional outcome

    Time frame: 3, 6,12 months after surgery

    Oswestry Disability Index (ODI)

  2. Self-perceived health status

    Time frame: 3, 6, 12 months after surgery

    EQ-5D

  3. Back and leg pain

    Time frame: 3, 6, 12 months after surgery

    Low Back Pain Rating Scale (LBPRS)

  4. Anxiety and Depression

    Time frame: 6, 12 months after surgery

    HADS

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Nov 26, 2015
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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