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
Condition: Depression and Self-Harm
MeSH terms: Depression; Depressive Disorder; Self-Injurious Behavior
Study type: Interventional

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).
    

Intervention name(s): Problem solving cognitive behaviour therapy (PS CBT)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment