ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 692 for:    BDI | "Depression"

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 (eDASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02377011
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Depression and Self-Harm Behavioral: Problem solving cognitive behaviour therapy (PS CBT) Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: PS CBT

Problem solving cognitive behaviour therapy (PS CBT) will be delivered remotely by means of telephone or video calling by a cognitive behaviour therapist in addition to their usual care.

The duration of the intervention will be 10 sessions. Research measures will be completed at baseline, 3,6,9 and 12 months

Behavioral: Problem solving cognitive behaviour therapy (PS CBT)
No Intervention: Treatment as Usual
Participants will not receive any CBT therapy in addition to their usual care. Research measures will be completed at baseline,3,6,9 and 12 months.



Primary Outcome Measures :
  1. Beck Depression Inventory (V2) [ Time Frame: Baseline to 6 months ]
    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.


Secondary Outcome Measures :
  1. Beck Depression Inventory (V2) [ Time Frame: Baseline to 12 months ]
  2. Time to Self-Harm [ Time Frame: Baseline to 12 months ]
    Time to self-harm, assessed through a self-report measure and verified through medical records where possible

  3. Patient Health Questionnaire 9 [ Time Frame: Baseline to 12 months ]
    Depressive symptoms on the PHQ-9 (Kroenke et al, 2001)

  4. Beck hopelessness scale [ Time Frame: Baseline to 12 months ]
    Hopelessness measured on the Beck hopelessness scale (Beck, 1988)

  5. Columbia Suicide Severity Rating Scale [ Time Frame: Baseline to 12 months ]
    Suicidality measured on the Columbia Suicide Severity Rating Scale (CSSRS; Posner et al, 2011).

  6. Social functioning [ Time Frame: Baseline to 12 months ]
    Social functioning measured using the work and social adjustment scale (WSAS; Mundt et al, 2002).

  7. Quality of life [ Time Frame: Baseline to 12 months ]
    Quality of life measured using EQ-5D (EuroQol Group, 1990).

  8. Cost Effectiveness [ Time Frame: Baseline to 12 months ]
    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.

  9. Qualitative Interviews [ Time Frame: Baseline to 12 months ]
    Explore reasons why individuals may or may not engage with the study and the PS CBT intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377011


Locations
United Kingdom
Derbyshire Healthcare NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3LZ
Derbyshire Hoispitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3NE
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield, Deryshire, United Kingdom, S44 5BL
Nottinghamshire Healthcare NHS foundation Trust.
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Kapil Sayal, PhD CLAHRC-EM, University of Nottingham

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02377011     History of Changes
Other Study ID Numbers: CLAHRC-EM 14059
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: June 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Self-Injurious Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders