Clinical trial NCT02377011: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression and Self-Harm
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Inventory (V2)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Beck Depression Inventory (V2)
timeFrame: Baseline to 12 months
measure: Time to Self-Harm
timeFrame: Baseline to 12 months
measure: Patient Health Questionnaire 9
timeFrame: Baseline to 12 months
measure: Beck hopelessness scale
timeFrame: Baseline to 12 months
measure: Columbia Suicide Severity Rating Scale
timeFrame: Baseline to 12 months
measure: Social functioning
timeFrame: Baseline to 12 months
measure: Quality of life
timeFrame: Baseline to 12 months
measure: Cost Effectiveness
timeFrame: Baseline to 12 months
measure: Qualitative Interviews
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Derbyshire Healthcare NHS Foundation Trust
state: Derbyshire
city: Derby
country: United Kingdom
facility: Derbyshire Hoispitals NHS Foundation Trust
state: Derbyshire
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital NHS Foundation Trust
state: Deryshire
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS foundation Trust.
state: Nottinghamshire
Study officials:
affiliation: CLAHRC-EM, University of Nottingham
name: Kapil Sayal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck AT. Beck Hopelessness Scale. The Psychological Corporation: San Antonio, Texas, 1988.
citation: Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.
citation: 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.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
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.
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
citation: Sayal K, Roe J, Ball H, Atha C, Kaylor-Hughes C, Guo B, Townsend E, Morriss R. Feasibility of a randomised controlled trial of remotely delivered problem-solving cognitive behaviour therapy versus usual care for young people with depression and repeat self-harm: lessons learnt (e-DASH). BMC Psychiatry. 2019 Jan 24;19(1):42. doi: 10.1186/s12888-018-2005-3.