LIGHTMind 2: Low-intensity guided help through mindfulness

INTERVENTION: This is a parallel groups, superiority pragmatic RCT with 1:1 allocation to MBCT‐SH or CBT‐SH with blinded assessments at all time points. Participants are blind to the hypothesised direction of effects. The study includes qualitative evaluation of participants’ experiences of both self‐help interventions with a focus on better understanding barriers and facilitators to engaging in self‐help interventions in IAPT. Four hundred and ten people meeting eligibility criteria for major depressive disorder or mixed anxiety and depression are randomly allocated to receive MBCT‐SH or CBT‐SH, along with six sessions of support from a psychological wellbeing practitioner. Participants complete measures at baseline, 16 weeks post‐randomisation (post‐intervention) and 42 weeks post randomisation (6‐months follow‐up). In addition, 32 participants are interviewed about their experiences. All potential participants complete a standard IAPT initial assessment. This includes completion of the PHQ‐9. Potential participants (i.e. those scoring 10‐19 inclusive on the PHQ‐9) are offered the study. Potential participants not meeting eligibility criteria are not be offered the study and are offered usual care by the IAPT service. If eligible and interested in the study, potential participants are given a copy of the Participant Information Sheet. Potential participants speak with a member of the research team to answer questions about the study and to complete the consent form (if appropriate). As assessment and intervention is typically offered by telephone at Step 2 in IAPT, participants are offered the choice of having the consent meeting by phone or in person. The consent form is presented online for participants to complete during the meeting (with hard copy option available). Potential participants not wanting to take part in the study are referred back to the person who conducted their initial IAPT assessment for usual care to be offered by the service. Once the participant has CONDITION: Specialty: Mental Health, Primary sub‐specialty: Depression; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders, Mental Health/ Neurotic, stress‐related and somatoform disorders ; Mental and Behavioural Disorders ; Depression PRIMARY OUTCOME: Depression symptom severity at post‐intervention. The PHQ‐9 is a 9‐item self‐report measure of depression symptom severity used in all IAPT services. Items are rated on a four‐point scale. The primary outcome for this study is change in PHQ‐9 score from baseline to 16 weeks post‐randomisation INCLUSION CRITERIA: 1. Be aged 18 years or over 2. Meet diagnostic criteria on the revised Clinical Interview Schedule (CIS‐R) for a primary diagnosis of a depressive episode, or mixed anxiety and depression 3. Score 10 or more on the PHQ‐9 at their initial IAPT assessment (the cut‐off for a major depressive episode); and 4. Have sufficient literacy skills to read and understand the self‐help materials SECONDARY OUTCOME: 1. Depression symptom severity is measured using the change in PHQ‐9 score from baseline to follow‐up (42 weeks post‐randomisation) is a secondary outcome for the study at follow‐up; 2. Generalised anxiety is measured using the GAD‐7 is a 7‐item measure of generalised anxiety used in IAPT. Items are rated on a 4‐point scale and the measure has excellent psychometric properties from baseline to post‐intervention and from baseline to follow‐up ; 3. Wellbeing is measured using the short version of the Warwick Edinburgh Mental Wellbeing Scale consists of 7 questions rated on a 5‐point scale designed to measure wellbeing from baseline to post‐intervention and from baseline to follow‐up are secondary outcomes; 4. Functioning is measured using the Work and Social Adjustment Scale (WSAS) is a 5‐item measure of daily occupational and social functioning that is used routinely in IAPT from baseline to post‐intervention and from baseline to follow‐up are secondary outcomes; 5. Mindfulness is measured using the 15‐item version of the Five‐Facet Mindfulness Questionnaire. from baseline to post‐intervention and from baseline to follow‐up are secondary outcomes; 6. Service use is measured using the a self‐report version of the Adult Service Use Schedule (ADSUS) will be used to collect data on resource used to estimate costs and will take the health and social services perspective at collected at baseline, post‐intervention (16 weeks post‐randomisation) and follow‐up (42 weeks post‐randomisation); 7. Health‐related quality of life is measured using the EQ‐5D is a five‐dimension, generic, preference‐based measure of health‐related quality of life covering mobility, self‐care, usual activities, pain/discomfort and anxiety/depression.at baseline, post‐intervention (16 weeks post‐randomisation) and follow‐up (42 weeks post‐randomisation).; ; Qualitative Evaluation:; The aim of the qualitative element of the study is to ascertain facilitators and barriers to treatment completion for each intervention given the well‐established problem with drop‐out from IAPT. Thirty‐two telephone interviews will be conducted with eight participants interviewed from each of the following four groups; (1) MBCT‐SH intervention completers, (2) MBCT‐SH intervention drop‐outs, (3) CBT‐SH intervention completers, (4) CBT‐SH intervention drop‐outs. This strategy will ensure that participants are interviewed in equal numbers from each intervention arm and that an equal number of intervention drop‐outs and completers are interviewed. Interviews will take place following the post‐intervention assessment in order to accurately capture participants’ experiences using the Change Interview.