Mood disorders were the most prevalent psychiatric hospital discharge diagnosis in women in Scotland in 2012 . In 2011/12 the total cost of antidepressant medication prescribed in Scotland was £31.4 million . There is evidence for the role of social and environmental influences on the development and course of depressive disorders . The World Health Organization states that, in the majority of cases, depression can be effectively treated within primary care . However, fewer than 50% of patients receive the necessary medication or psychotherapeutic treatments . This treatment gap may have occurred for a number of reasons, including non-recognition of the problem, non-presentation as a result of a fear of stigma, or limited knowledge about treatment options.
Community surveys have confirmed that members of the public give higher endorsements to self-help, voluntary sector and local support networks than for more formal treatment approaches . Interventions that emphasize community-based recruitment, self-referral and delivery of treatment courses via a voluntary sector group may engage people who would otherwise not receive appropriate help for depression within the health service, and may reduce the burden on the health service by providing an alternative treatment path for those who are already engaged. Voluntary sector groups are popular and provide important peer support. However, there may be advantages of adding in an evidence-based structure and content to the group sessions to enhance outcomes from this delivery approach.
Cognitive behavioral therapy
The National Institute for Health and Clinical Excellence (NICE) recommends cognitive behavioral therapy (CBT) for mild-to-moderate depression . Traditional CBT consists of 12 to 20 1-hour sessions with a mental health expert and can be delivered in primary care settings . However, it remains difficult to provide this high-intensity (HI) specialist CBT due to the large volume of patients with low mood, and as a result waiting lists are long. An alternative is to supplement HI delivery with low-intensity (LI) CBT . Several separate strands of LI delivery exist, including CBT delivered using bibliotherapy (written self-help books) and computerized CBT (cCBT) , as well as LI forms of classes/groups and behavioral activation. These are recommended as part of stepped-care approaches before HI CBT for mild-to-moderate depression. NICE  and Gellatly and colleagues  recommend that including guidance/support in using bibliotherapy and cCBT significantly improves outcomes for those with depression using these approaches. Crucially, the support does not need to be delivered by a mental health or CBT expert and the focus can be on supportive monitoring .
Such support is often provided on an individual basis by workers such as self-help coaches or psychological wellbeing practitioners. Self-help strategies with support may be as effective as HI specialist CBT for some , and are also a preferred treatment option for many users . Voluntary sector support is also viewed as attractive and avoids a formal mental health label and diagnosis. However, LI working usually relies on one-to-one support either face-to-face or by phone, and is still relatively time consuming.
An alternative is to provide access to specialist delivered face-to-face group therapy led by expert mental health practitioners. Existing HI specialist group CBT approaches include behavioral therapy groups consisting of 12 sessions, initially held twice weekly  attended by 6 to 10 adults and led by two highly trained group leaders. Such approaches are helpful  but are very therapist-intensive and access for patients is restricted.
Currently there are few face-to-face LI classes available and none have been adequately tested in a randomized controlled trial (RCT) setting. White has tested large psycho-educational classes for anxiety ; however, these do not specifically target depression. Brown and colleagues  reported the results of a large group class based on a widely used CBT book about confidence. Their classes included a high proportion of people with depression and focused on teaching how to apply a written self-help resource (bibliotherapy) for self-confidence, ‘Overcoming Low Self-esteem’. They were, however, delivered in a single one-off class with no on-going guidance or support for the application of the CBT self-help resources. NICE  identifies no LI guided CBT classes and no studies of LI-CBT classes that address depression and include health economic outcomes. It recommends classes with smaller numbers of attendees, rather than large group classes, and separately recommends the use of guided CBT self-help resources for guided/supported use by individuals.
This will be the first study to bring together these different strands by evaluating CBT self-help resources specifically for depression delivered with LI support/guidance via short, weekly, face-to-face, small group classes delivered through the voluntary sector. Our project draws on current NICE guidelines and offers the possibility of rapid access and larger throughput of numbers coupled with delivery by non-specialist trainers. The classes will be delivered by voluntary sector workers with a non-National Health Service (NHS) label (the mental health charity Action on Depression (AOD) - formerly Depression Alliance Scotland) in order to appeal to a wide range of people including those currently attending the NHS as well as those who are not. They will also allow self-referral, an approach which has been successfully used previously by Brown and colleagues  and which found that approximately one-third of the sample had mild depression, 37% had moderate/severe depression and 18% were in the ‘extremely severe depression’ category according to baseline Beck Depression Inventory  scores.
The Living Life to the Full classes
The Living Life to the Full (LLTTF) classes contain eight life skills sessions that teach a range of CBT-based life skills in a classroom setting based in a locally accessible location such as a library or hotel. Classes are attended by up to 16 people and last 90 minutes. Each weekly class focuses on a different common problem faced by people when they feel low or anxious. The class content is: 1) Why do I feel so bad? 2) I can’t be bothered doing anything. 3) Why does everything always go wrong? 4) I’m not good enough (low confidence). 5) How to fix almost everything. 6) The things you do that mess you up. 7) Are you strong enough to keep your temper? 8) Ten things you can do to help you feel happier straight away. The classes use everyday terms and avoid professional terminology. They are designed to encourage an individualized plan to be made at the end of each session using a Plan, Do, Review structure . Each class consists of slides, course leader notes/scripts, worksheets and a linked booklet that summarizes the topic and includes work tasks to facilitate practice at home. The classes offer guided CBT for depression delivered over a series of eight class-based sessions delivered over eight weeks. Each class is delivered using a mix of didactic teaching, question and answer discussion and tasks in groups or pairs. There are currently no equivalent classes using the same model of delivery. This accessibility is reinforced by the language used (that is, the “class” not “group”, “life skills training” instead of “CBT” and “low mood and stress” rather than “depression and anxiety”). The way of communicating CBT is highly accessible  and effective [21, 22]. The language used in the classes includes everyday terms to describe symptoms such as stress, distress and low mood rather than the more formal diagnostic terms depressive disorder, depression and anxiety, and so on. The aim is to be inclusive and appealing to participants who are being recruited through a community-based initiative.
A ninth session, Planning for the Future and Reunion, is held 6 weeks after the final class. The class takes place about 6 weeks after the core 8-week course as it is thought that this is an appropriate duration for participants to integrate/apply the skills they have learned in the course in their everyday lives. The revision class therefore serves as a booster session to keep participants on track with the intervention, as they are advised to continue using the resources after the group support ends for optimal benefit.
Results of pilot studies
The classes are used in Scotland as part of the Widening Access to Self-help project an extension of the Scottish Government funded Doing Well by People with depression program  and have proved popular and accessible. An independent Health and Social Board national pilot study conducted by AWARE Defeat Depression, a charity in Northern Ireland, evaluated 46 groups (356 individuals) who took part in the classes. The General Health Questionnaire-12  found only 9.8% of participants self-rated as ‘Happy’ at the start of the intervention compared to over 60% at the end, which was a statistically significant change (P < 0.001). Additionally, 77% rated themselves as being in the ‘Depressed’ category before the program, with only 21% depressed post-intervention. The classes also significantly improved knowledge and understanding in relation to stress and low mood. In Scotland, we have recently run a pilot of the face-to-face classes also with statistically significant improvements in low mood. Also, the Equally Connected Equality Team at NHS Lothian ran the LLTTF classes as a pilot in Black and Minority Ethnic settings. They found that 100% of respondents agreed or strongly agreed that the classes had been helpful .
However, to date there have been no large RCTs of the classes and NICE has identified a need for such studies with a health economic component to be completed. We have, therefore, recently undertaken a pilot RCT using the same design as the current application. This has allowed us to test and be confident of our recruitment process, establish power and test the delivery of the intervention and research. In a previous pilot in Glasgow and Northern Ireland (with course delivery by the charities AOD and AWARE), we successfully screened and randomized 53 participants using the same planned recruitment strategy. Mean differences at the primary follow-up point (3 months) have informed our power calculation (see below).
We have therefore successfully tested recruitment, questionnaire delivery and data collection, randomization and delivery of the face-to-face classes in the community. This substantive RCT differs in so far as it has been modified to include a 6 month rather than 12 week primary endpoint and is powered to definitively answer the question of whether the LLTTF course is an effective treatment for low mood. The 6 month primary follow-up point will allow a longer-term impact of the intervention to be assessed and groups can be compared at this time point whilst the delayed access control (DAC) remain a control group. As this is a long-term follow-up point, participants may seek additional support prior to follow-up; data on services accessed during the study will be collected at 6 months using the Client Service Receipt Inventory (CSRI).
This is an RCT comparing class-delivered guided CBT self-help using the LLTTF classes, with a DAC who will receive the intervention after 6 months. We will follow-up participants until 6 months, which represents a reasonable level of sustainability. Our trial experience and recent review makes us feel that the delayed treatment arm as opposed to treatment as usual is necessary to maximize recruitment and retention for this population . To address stigma and encourage self-referral (known to address the treatment gap), both recruitment and delivery will take place in community settings and recruit directly through community-based adverts supplemented with advertisements through AOD.
The aim of this substantive study is to recruit people experiencing significant depression, and to include both those already receiving NHS support as well as those who are not. We will include both those with clinically diagnosed major depression as well as those with significantly raised mood scores. We will describe the population in detail in terms of mood severity and clinical diagnosis. The study will assess the effectiveness of LLTTF in reducing symptoms of depression and anxiety and in improving social functioning. Effectiveness will be measured using standardized outcome measures that address a broad range of outcomes. The cost effectiveness of this intervention will also be investigated using the CSRI  to estimate personal and healthcare costs and the EuroQuol EQ5D  as a measure of quality of life.
Do the LLTTF classes result in an improvement in symptoms of depression and anxiety at 6 months compared to a DAC group, as measured by the patient health questionnaire-9 (PHQ9)  and generalized anxiety disorder 7 (GAD7) .
Do the LLTTF classes result in an improvement in symptoms of depression and anxiety at 6 months compared to DAC, as measured by the PHQ9 and GAD7 for those with a baseline PHQ9 score of 10+ and those with a score of 5 to 9?
Do the LLTTF classes result in an improvement in social function at 6 months compared to DAC as measured by the Work and Social Adjustment Scale (WSAS) ?
Are the LLTTF classes cost effective?
Are the LLTTF classes satisfactory to participants?