RCT of the Clinical and Cost Effectiveness of Cognitive Behaviour Therapy (CBT) Delivered Remotely Versus Treatment as Usual in Adolescents and Young Adults With Depression Who Repeatedly Self-harm

Depression and Self-Harm Clinical Trial

— eDASH  

Official title:

Randomised Controlled Trial of the Clinical and Cost Effectiveness of NICE Recommended Problem Solving Cognitive Behaviour Therapy (PS CBT) Delivered Remotely Versus Treatment as Usual in Adolescents and Young Adults With Depression Who Repeatedly Self-harm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377011
• Other study ID #: CLAHRC-EM 14059
• Status: Completed
• Phase: N/A
• First received: February 25, 2015
• Last updated: January 16, 2018
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial to test the whether remote delivery of cognitive based therapy (CBT) is clinically and cost effective when compared to treatment as usual in adolescents and young adults with depression who self-harm.

Description:

Self harm is one of the five leading causes of admission to acute hospital with rates increasing by nearly 50% from 2003-2009 (South West Public Health Observatory, 2012). Re-admission within 30 days is frequent. People who repeatedly self harm are at high risk for suicide and and as a result suicide, self-harm and crisis are priorities for CCGs and HWBs in the East Midlands.

The NICE Clinical Guideline 133 on longer-term treatment of self-harm recommends between 3 to 12 sessions of psychological treatment involving problem solving and alternative coping. Presently however, the biggest at risk group for self-harm and suicide is not offered any psychological treatment.

Studies have shown that mobile phones are a highly acceptable method of engaging adolescents with depression in psychological treatments such as CBT (Whittaker et al 2012). Furthermore a systematic review has show that treatment delivery via remote technology is just as effective as face-to-face in people with anxiety or depression (Bee et al, 2008).

The study therefore has the following aims and objectives:

1. To optimise and determine the acceptability and feasibility of engaging and retaining patients with depression who repeatedly self-harm in a remotely delivered (through video calling/telephone) CBT intervention over 10 sessions.

2. To outline the barriers and drivers to delivering both the study and the remotely delivered PS CBT intervention and how barriers to the interventions are addressed through a network of practice or other means.

3. If the recruitment and retention into the study and the remotely delivered PS therapy are feasible and acceptable, then we will determine the clinical effectiveness and cost effectiveness of the intervention versus treatment as usual.

4. If the intervention (pilot study) proves to be clinically effective and cost effective then the barriers and drivers to implementation in all counties in the East Midlands will be explored using a network of practice linking with NHS organisations, strategic clinical networks, and the AHSN (see qualitative analysis of barriers and drivers to the implementation of the intervention below).

The main hypothesis of this study is:

Adolescents and young adults who receive problem solving cognitive behaviour therapy (plus treatment as usual) will report greater reduction in their depressive symptoms (as measured using Beck depression inventory 2) from baseline to 6 months in comparison to those receiving treatment as usual.

Secondary objectives will be to observe a change over 12 months on measures of depression, hopelessness and suicidality.

Study configuration:

This study will compare two groups: participants will be randomly assigned to the TAU group (control group) or the remotely delivered PS CBT (and TAU) group (intervention group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

Inclusion Criteria:

• >2 self-harm episodes.

• With high levels of unipolar depressive symptoms (BDI-2 score of 17 or more).

• Sufficient understanding of English (spoken and written).

• Ability to give informed consent

Exclusion Criteria:

• Clinical judgement of high level of suicide risk, other risk to self or others requiring other urgent approaches e.g. admission to mental health unit.

• Other severe mental illness e.g. psychosis, bipolar disorder, substance use disorder or organic mental disorder e.g. secondary to head injury as the primary mental health problem as determined by a structured psychiatric interview (SCID).

• Currently receiving structured psychological therapy

Related Conditions & MeSH terms

• Depression
• Depression and Self-Harm
• Depressive Disorder

Intervention

Behavioral:
• Problem solving cognitive behaviour therapy (PS CBT)

Locations

Country	Name	City	State
United Kingdom	Chesterfield Royal Hospital NHS Foundation Trust	Chesterfield	Deryshire
United Kingdom	Derbyshire Healthcare NHS Foundation Trust	Derby	Derbyshire
United Kingdom	Derbyshire Hoispitals NHS Foundation Trust	Derby	Derbyshire
United Kingdom	Nottinghamshire Healthcare NHS foundation Trust.	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.

Beck AT. Beck Hopelessness Scale. The Psychological Corporation: San Antonio, Texas, 1988.

Bee PE, Bower P, Lovell K, Gilbody S, Richards D, Gask L, Roach P. Psychotherapy mediated by remote communication technologies: a meta-analytic review. BMC Psychiatry. 2008 Jul 22;8:60. doi: 10.1186/1471-244X-8-60. Review. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Whittaker R, Merry S, Stasiak K, McDowell H, Doherty I, Shepherd M, Dorey E, Parag V, Ameratunga S, Rodgers A. MEMO--a mobile phone depression prevention intervention for adolescents: development process and postprogram findings on acceptability from a randomized controlled trial. J Med Internet Res. 2012 Jan 24;14(1):e13. doi: 10.2196/jmir.1857. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (V2)	The difference of change in self-rated depression as measured by Beck depression inventory (version 2) from baseline to 6 months, between the control and intervention group.	Baseline to 6 months
Secondary	Beck Depression Inventory (V2)		Baseline to 12 months
Secondary	Time to Self-Harm	Time to self-harm, assessed through a self-report measure and verified through medical records where possible	Baseline to 12 months
Secondary	Patient Health Questionnaire 9	Depressive symptoms on the PHQ-9 (Kroenke et al, 2001)	Baseline to 12 months
Secondary	Beck hopelessness scale	Hopelessness measured on the Beck hopelessness scale (Beck, 1988)	Baseline to 12 months
Secondary	Columbia Suicide Severity Rating Scale	Suicidality measured on the Columbia Suicide Severity Rating Scale (CSSRS; Posner et al, 2011).	Baseline to 12 months
Secondary	Social functioning	Social functioning measured using the work and social adjustment scale (WSAS; Mundt et al, 2002).	Baseline to 12 months
Secondary	Quality of life	Quality of life measured using EQ-5D (EuroQol Group, 1990).	Baseline to 12 months
Secondary	Cost Effectiveness	A modified version of the Client Service Receipt Inventory (CSRI; Beecham & Knapp, 2001): to measure costs, service utilisation, income and related matters to analyse cost effectiveness.	Baseline to 12 months
Secondary	Qualitative Interviews	Explore reasons why individuals may or may not engage with the study and the PS CBT intervention	Baseline to 12 months