Depression and Self-HarmeDASHNCT02377011
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
A study testing Problem solving cognitive behaviour therapy (PS CBT) in people with Depression and Self-Harm, run by University of Nottingham at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Depression and Self-Harm
- What is being tested?
- Problem solving cognitive behaviour therapy (PS CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield, Deryshire, S44 5BL
Derbyshire Healthcare NHS Foundation Trust
Derby, Derbyshire, DE22 3LZ
Derbyshire Hoispitals NHS Foundation Trust
Derby, Derbyshire, DE22 3NE
Nottinghamshire Healthcare NHS foundation Trust.
Nottingham, Nottinghamshire, NG3 6AA
About this study
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
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.
Read the 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:
- 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.
- 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.
- 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.
- 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).
- Conditions
- Depression and Self-Harm
- Being tested
- Problem solving cognitive behaviour therapy (PS CBT)
- Medical subject headings
- Depression, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem solving cognitive behaviour therapy (PS CBT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| PS CBT | Experimental | 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 Receives: Behavioral: Problem solving cognitive behaviour therapy (PS CBT) |
| Treatment as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (9)
Beck Depression Inventory (V2)
Measured: Baseline to 12 months
Time to Self-Harm
Time to self-harm, assessed through a self-report measure and verified through medical records where possible
Measured: Baseline to 12 months
Patient Health Questionnaire 9
Depressive symptoms on the PHQ-9 (Kroenke et al, 2001)
Measured: Baseline to 12 months
Beck hopelessness scale
Hopelessness measured on the Beck hopelessness scale (Beck, 1988)
Measured: Baseline to 12 months
Columbia Suicide Severity Rating Scale
Suicidality measured on the Columbia Suicide Severity Rating Scale (CSSRS; Posner et al, 2011).
Measured: Baseline to 12 months
Social functioning
Social functioning measured using the work and social adjustment scale (WSAS; Mundt et al, 2002).
Measured: Baseline to 12 months
Quality of life
Quality of life measured using EQ-5D (EuroQol Group, 1990).
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
Qualitative Interviews
Explore reasons why individuals may or may not engage with the study and the PS CBT intervention
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depression and Self-HarmStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kapil Sayal, PhD, Principal investigator, CLAHRC-EM, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377011
- Sponsor's protocol ID
- CLAHRC-EM 14059
- Acronym
- eDASH
- Status last verified
- Jun 2016
- First submitted
- 25 Feb 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beck AT. Beck Hopelessness Scale. The Psychological Corporation: San Antonio, Texas, 1988.
Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.
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.
PubMed 18647396EuroQol 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.
PubMed 10109801Whittaker 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.
PubMed 22278284Witt 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.
PubMed 33884617Sayal 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.
PubMed 30678674
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02377011
- Acronym / sponsor ID
- eDASH / CLAHRC-EM 14059
- Conditions
- Depression and Self-Harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS CBT | Experimental | Behavioral: Problem solving cognitive behaviour therapy (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 |
| Treatment as Usual | No intervention | –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. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem solving cognitive behaviour therapy (PS CBT) | Behavioural | PS CBT |
Primary outcome
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.
9 secondary outcomes
Beck Depression Inventory (V2)
Time frame: Baseline to 12 months
Time to Self-Harm
Time frame: Baseline to 12 months
Patient Health Questionnaire 9
Time frame: Baseline to 12 months
Beck hopelessness scale
Time frame: Baseline to 12 months
Columbia Suicide Severity Rating Scale
Time frame: Baseline to 12 months
Social functioning
Time frame: Baseline to 12 months
Quality of life
Time frame: Baseline to 12 months
Cost Effectiveness
Time frame: Baseline to 12 months
Qualitative Interviews
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- BackgroundBeck AT. Beck Hopelessness Scale. The Psychological Corporation: San Antonio, Texas, 1988.
- BackgroundBeck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation, 1996.
- Background: PubMed 18647396Bee 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.
- Background: PubMed 10109801EuroQol 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.
- Background: PubMed 22278284Whittaker 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.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 30678674Sayal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kapil Sayal, PhD principal investigator
CLAHRC-EM, University of Nottingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem solving cognitive behaviour therapy (PS CBT) in people with Depression and Self-Harm, run by University of Nottingham at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (V2) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377011, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.