Condition category
Mental and Behavioural Disorders
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
14/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression is a serious and growing global health problem and previous research has shown that psychological therapies are as effective as medication in its treatment. In the UK, the NHS has developed a programme called Improving Access to Psychological Therapies (IAPT), which aims to widen patients’ choice of available therapies for depression and anxiety. The options offered by IAPT follow national recommendations (as outlined by the National Institute of Clinical Excellence [NICE] depression guidelines), which highlight short-term psychodynamic psychotherapy (STPP) as one of the treatment types that can be effective for adults with depressive illness. There are several forms of STPP, one of which is Dynamic Interpersonal Therapy (DIT). While there is evidence that short-term psychodynamic psychotherapy is generally effective, the DIT package specifically continues to be perfected so it is important to investigate it through a full, large-scale research study and broaden the evidence for its effectiveness within IAPT services. The REDIT study is a research study designed precisely to investigate the effectiveness of Dynamic Interpersonal Therapy (DIT) as a depression treatment within IAPT services. The study will compare the outcomes of patients diagnosed with depression who are receiving immediate DIT with those of patients on an enhanced wait list (including elements of low-intensity routine care) followed by DIT after a period of approximately 16 weeks. The current study is a 'pilot' study, which will help prepare the way for an even larger trial of DIT to be conducted in the future.

Who can participate?
100 adults (aged 18 years and above) will be invited to join the REDIT study because they have a depressive illness and are attending IAPT services in one of the two sites in London where the study is being held (Newham and Tower Hamlets).

What does the study involve?
Each of these 100 eligible participants will be randomly allocated either to receive either immediate DIT for 16 weeks, or to be on the enhanced wait list for 16 weeks and then receive DIT.
Taking part in REDIT is voluntary at all times, so if you do decide to take part you can choose to withdraw (either from their treatment, from the research appointments or both) at any time without providing a reason. If you consent to being in the study, and where the study is considered suitable for you after the first research assessment and clinical assessment, you would meet with a researcher three times in total (separately but in addition to your appointments with the therapist) to enable him/her to collect the necessary research information. The information that the research team will be interested in gaining from you will relate to your feelings, mood and depressive symptoms: this means that the researcher will ask questions and will also provide some questionnaires for you to complete. After the first meeting with the researcher, if you are eligible for the study, you will be randomly allocated to one of the treatment conditions in the study and will then meet with the researcher twice more: 8 weeks after being allocated to treatment (i.e. half-way through the treatment course) and then again 17-18 weeks after allocation (i.e. at the end of the treatment course). REDIT participants will also be invited to take part in a sub-branch of the study if they would like to: this involves having some MRI pictures done of the brain while doing a few simple tasks on a computer. This part of the study is called ‘fMRI-REDIT’. The aim of it is to help us understand the relationship between how the brain works and depression. We are especially interested to see whether some patterns in the way the brain behaves might affect how well different people respond to treatment for depression within the main REDIT study. Studies like this one are important, because the more we can understand about the brain and how it works when a person experiences depression, the more suitable and effective therapies can then hopefully be developed. The ‘fMRI’ in fMRI-REDIT stands for ‘functional magnetic resonance imaging’. This is a method used to scan a person’s brain using a special scanner, in order to see how the brain reacts while he or she does various activities: for example, choosing between two objects on a screen, completing a puzzle, and so on. Typically, the pictures of your brain will show which parts are most active depending on the task you are doing. This is slightly different to magnetic resonance imaging – ‘MRI’ – which produces a picture of how the brain is structured rather than how it behaves. This part of the study is also completely voluntary and participants can choose only to stick with the main REDIT study if they prefer, or consent separately to the MRI part as well.

What are the possible benefits and risks of participating?
Whichever treatment you receive within the REDIT study, you will be given regular, structured support and will be monitored closely throughout your time in the study. The REDIT study will help us to explore and improve the way that DIT is used in routine practice. It will also set the ground for an even bigger study in the future that will give us more information to monitor the effectiveness of this treatment. You might feel good to know that you have contributed to this research and that studies such as REDIT will ultimately lead to better service provisions for others in the future. Some individuals can find it upsetting talking about their thoughts and feelings - both with their therapist and/or the researcher - but this usually gets better as treatment progresses. All information gathered by the researcher during your research appointment with them is strictly confidential, but if there is anything that you do not wish to discuss, or if you wish to interrupt the interview for any reason, the researcher will talk to you about this and pause or stop if asked to do so.

Where is the study run from?
Two sites in London where the study is being held (Newham and Tower Hamlets).

When is the study starting and how long is it expected to run for?
December 2010 to December 2016

Who is funding the study?
The Department of Health is supporting the central coordination of the study through the Anna Freud Centre and University College London.

Who is the main contact?
Ms Sally Parkinson
Sally.Parkinson@annafreud.org

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sally Parkinson

ORCID ID

Contact details

Anna Freud Centre
12 Maresfield Gardens
London
NW3 5SU
United Kingdom
+44 20 7443 2282
Sally.Parkinson@annafreud.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11833

Study information

Scientific title

Psychodynamic Psychotherapy in Primary Care: A Randomised Study to evaluate the effectiveness of Dynamic Interpersonal Therapy (DIT)

Acronym

REDIT

Study hypothesis

The aim of this study is to investigate the effectiveness of Dynamic Interpersonal Therapy (DIT) as a depression treatment within IAPT services.

Ethics approval

NRES Committee London - City & East, 05/04/2011, ref: 11/LO/0250

Study design

Single-blind multi-site randomised controlled feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression

Intervention

Participants were randomised to either the DIT or the ‘enhanced waiting list’ condition using a minimization algorithm with an 80% bias to minimize imbalance. Minimisation criteria included severity of depression (above or below median for site) and age (above or below median age for site).

Dynamic Interpersonal Therapy (DIT)
Dynamic Interpersonal Therapy (DIT) is a form of brief psychodynamic psychotherapy (16 sessions) developed for treating depression. It can help people with emotional and relationship problems. It explores difficult things in the past that continue to affect the way people feel and behave in the present. The therapy takes place over 16 weeks.

Enhanced Waiting List Condition
Enhanced waiting list participants will have contact with a psychological well-being practitioner once a fortnight. This will include help with general well-being & support, anxiety/panic management advice, sleep hygiene, employment support, learning cognitive restructuring techniques and other elements as necessary for 16 weeks.

Participants were followed up mid-treatment (8 weeks), at the end of treatment (approx. 16 weeks), and post-treatment (52 and 86 weeks).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome as of 14/06/2016:
Depression severity is measured using a semi-structured interview, the Hamilton Depression Rating Scale (HDRS-17) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks).

Original primary outcome:
Hamilton Depression Rating Scale (HDRS-17) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)

Secondary outcome measures

Secondary outcome as of 14/06/2016:
1. Depression severity is measured using the Beck Depression Inventory (BDI-II) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
2. Psychological distress is measured using the Brief Symptom Inventory (BSI) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
3. Quality of life is measured using EuroQOL (EQ-5D) questionnaire at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
4. Comorbidity of a range of psychiatric diagnoses are measured using the MINI+ interview (MINI International Neuropsychiatric Interview) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
5. Reflective functioning is measured using the Reflective Function Questionnaire (RFQ-54) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
6. Social adjustment is measured using the Revised Social Adjustment Scale (SAS-r) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks)
7. Interpersonal difficulties are measured using the Inventory of Interpersonal Problems (IIP-64) questionnaire at baseline, end-of-treatment (approx.. 16 weeks), and long-term follow-ups (52 and 86 weeks)
8. Adult attachment is measured using the Experiences in Close Relationships - Revised (ECR-R) questionnaire at baseline, end-of-treatment (approx.. 16 weeks), and long-term follow-ups (52 and 86 weeks)

Original secondary outcome measures:
1. Beck Depression Inventory (BDI-II) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)
2. Brief Symptom Inventory (BSI) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)
3. EuroQOL (EQ-5D) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)
4. MINI+ (Mini-International MINI international neuropsychiatric interview) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)
5. Reflective Function Questionnaire (RFQ-54) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)
6. Revised Social Adjustment Scale (SAS-r) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks)

Overall trial start date

01/12/2010

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years, male or female
2. Current diagnosis of Major depressive disorder (MDD) with or without dysthymic disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
3. Hamilton Depression Rating Scale score above 14
4. Patient Health Questionnaire (PHQ) score above 10
5. Confirmed need for high-intensity treatment either at triage, following referral, or by low-intensity worker and supervisor

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Current psychotic symptoms or bipolar disorder
2. Current use of antipsychotic medication
3. Complex Personality Disorder
4. Historic or current self-injury/parasuicide
5. Historic or current eating disorder
6. Current excessive use of drugs/alcohol
7. Non-English speaking
8. Participation in another depression clinical trial within the last year where subject has received CBT
9. Previous unsuccessful CBT treatment
10. Clinical contra-indication to short-term psychotherapy (e.g. attachment history - multiple separations, serious ongoing trauma in childhood, multiple care-givers - suggesting the need for longer term psychotherapy)
11. Evidence of pervasive use of help
12. Highly unstable or insecure life arrangements (e.g. domestic violence)

Recruitment start date

01/11/2012

Recruitment end date

28/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anna Freud Centre
London
NW3 5SU
United Kingdom

Sponsor information

Organisation

Tavistock and Portman NHS Foundation Trust (UK)

Sponsor details

c/o Alessandra Lemma
The Tavistock Centre
120 Belsize Lane
London
NW3 5BA
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR (UK) -Research for Patient Benefit Programme Grant Codes: PB-PG-0610-22287

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

After completing long-term follow-ups, the study will be published in a peer reviewed journal.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/06/2016: Further details about what the treatment involves in the intervention arm of the study and details of follow up have been added to the interventions section, and the primary and secondary outcome measures sections have been updated. Additionally, the overall trial dates have been changed from 20/06/2012 - 20/06/2013 to 01/12/2010 - 31/06/2016 and the recruitment dates have been changed from 20/06/2012 - 20/06/2013 to 01/11/2012 - 28/01/2015. The study contact has also been updated from Ms Tara McFarquhar to Ms Sally Parkinson. 09/06/2016: No publications found, verifying study status with principal investigator.