The READY feasibility trial is taking place in Hertfordshire, Bedfordshire, and Norfolk with GP involvement. The intervention will be delivered by registered exercise professionals (REP), employed by local physical activity providers (e.g. Watford FC Community and Sports Trust, Active Luton, Norwich City FC Community Sports Foundation), in local community venues (e.g. sports facilities and community halls).

The inclusion criteria includes help-seeking young people aged 13–17 years with a Children’s Depression Inventory (CDI 2[44]) score between 17 and 36 (mild to moderate symptoms), who understand their role in the trial and are able to complete trial activities, who can get to the intervention venue, consent to participate, with the consent form being completed for parent/carer for under 16 s and consent of parent/carer to provide data and take part in the study, and both young person and parent/carer able to complete the questionnaires in English. Current treatment with antidepressants or other drug(s) or psychological therapy is allowed.

The exclusion criteria includes being considered unsuitable by the clinician screening for eligibility, their current treatment or co-morbid conditions presenting contraindications to engaging in the RCT or exercise, active psychosis, significant substance abuse, self-harm, or suicidal ideation presenting significant risk (assessed as part of the Development and Wellbeing Assessment (DAWBA)).

The intervention sessions will run twice a week for 12 weeks, with a 15–20 min ‘healthy living’ behaviour change portion of the session (in all arms), followed by the exercise or social portion of the sessions. The proposed exercises are based on research by Weston et al. [45] who developed an exercise protocol from qualitative data collected at focus groups from adolescent school children. It incorporates activities which will appeal to both males and females and has been designed with the consultation of a range of young people.

This is composed of high-intensity exercises of alternating training sessions [45, 46] (e.g. basketball, football, boxing drills—see Table 1 for full breakdown) beginning with a 10-min warm up, culminating with a 5-min whole body cool down. Young people will perform four repetitions of 45 s of maximal effort exercise (> 90% predicted maximal heart rate) with 90 s rest in between each repetition (approximately 9 min). This will increase by 2 min and 15 s every 2 weeks (e.g. one repetition of 45 s of exercise and 90 s rest) for the first 6 weeks and 4 min 30 s (e.g. two repetitions of 45 s of exercise and 90 s rest) in the last 6 weeks. The final 2 weeks will be 12 repetitions (27 min of exercise). Heart rate monitors will be used to tailor each person’s maximum intensity and measure exertion in each session [47].

Exercise session outline

10 min warm up

Boxing (4 reps of 45 s and 90 s rest)

5 min cool down

Total time: 24 min

10 min warm up

Walking football (7.5 min halves)

2 min rest at half time

5 min cool down

Total time: 32 min

10 min warm up

Circuit training to music (4 reps of 45 s and 90 s rest)

5 min cool down

Total time: 24 min

10 min warm up

Walking netball (7.5 min halves)

2 min rest at half time

5 min cool down

Total time: 32 min

10 min warm up

Football (4 reps of 45 s and 90 s rest)

5 min cool down

Total time: 24 min

10 min warm up

Walking basketball (7.5 min halves)

2 min rest at half time

5 min cool down

Total time: 32 min

10 min warm up

Basketball (4 reps of 45 s and 90 s rest)

5 min cool down

Total time: 24 min

10 min warm up

Walking dodgeball (7.5 min halves)

2 min rest at half time

5 min cool down

Total time: 32 min

10 min warm up

Choice/combination (5 reps of 45 s and 90 s rest)

5 min cool down

Total time: 26 min 15 s

10 min warm up

Walking choice (9 min halves)

2 min rest at half time

5 min cool down

Total time: 35 min

10 min warm up

Boxing (5 reps of 45 s and 90 s rest)

5 min cool down

Total time: 26 min 15 s

10 min warm up

Walking choice (9 min halves)

2 min rest at half time

5 min cool down

Total time: 35 min

10 min warm up

Circuit training to music (5 reps of 45 s and 90 s rest)

5 min cool down

Total time: 26 min 15 s

10 min warm up

Walking choice (9 min halves)

2 min rest at half time

5 min cool down

Total time: 35 min

10 min warm up

Football (5 reps of 45 s and 90 s rest)

5 min cool down

Total time: 26 min 15 s

10 min warm up

Walking choice (9 min halves)

2 min rest at half time

5 min cool down

Total time: 35 min

10 min warm up

Basketball (6 reps of 45 s and 90 s rest)

5 min cool down

Total time: 28 min 30 s

10 min warm up

Walking choice (10.5 min halves)

2 min rest at half time

5 min cool down

Total time: 38 min

10 min warm up

Choice/combination (6 reps of 45 s and 90 s rest)

5 min cool down

Total time: 28 min 30 s

10 min warm up

Walking choice (10.5 min halves)

2 min rest at half time

5 min cool down

Total time: 38 min

10 min warm up

Boxing (6 reps of 45 s and 90 s rest)

5 min cool down

Total time: 28 min 30 s

10 min warm up

Walking choice (10.5 min halves)

2 min rest at half time

5 min cool down

Total time: 38 min

10 min warm up

Circuit training to music (6 reps of 45 s and 90 s rest)

5 min cool down

Total time: 28 min 30 s

10 min warm up

Walking choice (10.5 min halves)

2 min rest at half time

5 min cool down

Total time: 38 min

10 min warm up

Football (8 reps of 45 s and 90 s rest)

5 min cool down

Total time: 33 min

10 min warm up

Walking choice (13.5 min halves)

2 min rest at half time

5 min cool down

Total time: 44 min

10 min warm up

Basketball (8 reps of 45 s and 90 s rest)

5 min cool down

Total time: 33 min

10 min warm up

Walking choice (13.5 min halves)

2 min rest at half time

5 min cool down

Total time: 44 min

10 min warm up

Choice/combination (8 reps of 45 s and 90 s rest)

5 min cool down

Total time: 33 min

10 min warm up

Walking choice (13.5 min halves)

2 min rest at half time

5 min cool down

Total time: 44 min

10 min warm up

Boxing (8 reps of 45 s and 90 s rest)

5 min cool down

Total time: 33 min

10 min warm up

Walking choice (13.5 min halves)

2 min rest at half time

5 min cool down

Total time: 44 min

10 min warm up

Circuit training to music (10 reps of 45 s and 90 s rest)

5 min cool down

Total time: 37 min 30 s

10 min warm up

Walking choice (16.5 min halves)

2 min rest at half time

5 min cool down

Total time: 50 min

10 min warm up

Football (10 reps of 45 s and 90 s rest)

5 min cool down

Total time: 37 min 30 s

10 min warm up

Walking choice (16.5 min halves)

2 min rest at half time

5 min cool down

Total time: 50 min

10 min warm up

Basketball (10 reps of 45 s and 90 s rest)

5 min cool down

Total time: 37 min 30 s

10 min warm up

Walking choice (16.5 min halves)

2 min rest at half time

5 min cool down

Total time: 50 min

10 min warm up

Choice/combination (10 reps of 45 s and 90 s rest)

5 min cool down

Total time: 37 min 30 s

10 min warm up

Walking choice (16.5 min halves)

2 min rest at half time

5 min cool down

Total time: 50 min

10 min warm up

Boxing (12 reps of 45 s and 90 s rest)

5 min cool down

Total time: 42 min

10 min warm up

Walking choice (2 × 10 min and 2 × 9 min quarters)

1 min rest between

5 min cool down

Total time: 57 min

10 min warm up

Circuit training to music (12 reps of 45 s and 90 s rest)

5 min cool down

Total time: 42 min

10 min warm up

Walking choice (2 × 10 min and 2 × 9 min quarters)

1 min rest between

5 min cool down

Total time: 57 min

10 min warm up

Football (12 reps of 45 s and 90 s rest)

5 min cool down

Total time: 42 min

10 min warm up

Walking choice (2 × 10 min and 2 × 9 min quarters)

1 min rest between

5 min cool down

Total time: 57 min

10 min warm up

Basketball (12 reps of 45 s and 90 s rest)

5 min cool down

Total time: 42 min

10 min warm up

Walking choice (2 × 10 min and 2 × 9 min quarters)

1 min rest between

5 min cool down

Total time: 57 min

On arrival, participants get changed. They will also put the heart rate monitor on, and this will be demonstrated in an earlier session

High-intensity interval training exercises

Boxing

Reps can include any of the following:

• Ten jabs, followed by running to the end of the sports hall and back

• Ten hooks, followed by five squat thrusts

• Fast upper cuts

• Ten jabs, followed by five-star jumps

• Fast jabs

• Ten side steps, followed by running to the end of the sports hall and back

• Five combination punches (hook and jab), followed by running to the end of the sport hall and back

• Ten of favourite punch action, followed by ten tuck jumps

Circuit training to music

• Full star jumps

• Tuck jumps

• Stationary high knees runs

• Jumping with one hand in the air

• Hop on one leg

• Push ups

• Sit ups

• High leg kicks

• Fast side kicks

• Fast side to side twists

Football

• Ten toe touches, followed by running to a cone and back

• Running up to kick the ball ten times, followed by five burpees

• Sprinting around cones in the sports hall

• Kicking a football into a goal then running to end of the sports hall and back. Performing fast feet movements through cones then running to end of the sport hall and back

• Jumping up to head a football five times then running to the end of the sports hall and back

• Running around the sports hall following a square or diagonal course

Basketball

• Receiving and returning a chest pass, followed by running to a cone and back

• Running around in a square and receiving and returning a bounce pass on one corner of the square

• Bouncing a ball five times then running to the end of the hall and back

• Receiving a shoulder pass, followed by running to a cone and back

This is composed of low-intensity exercise of alternating training sessions [48] (e.g. walking football, walking netball). These activities elicit a heart rate between 40 and 50% maximal effort based on the activity compendium [49]. The sessions will follow the same warm up and cool down as the high intensity, but the overall exercise session will be longer (to energy match to high intensity). The first 2 weeks will start at 15 min of exercise with a 2-min break in the middle. This will increase by 3 min every 2 weeks for the first 6 weeks, and 6 min every 2 weeks for the second 6 weeks. The last 2 weeks will therefore consist of 38 min of exercise (including the break).

A pilot study was conducted to ensure that the low- and high-intensity arms will exert an equivalent amount of energy, using a standardised protocol [Bottoms, Howlett, Chater, Jones, Jones, Wyatt, et al. Energy matching of a high intensity exercise protocol with a low intensity exercise protocol in adolescents. Under Review.]. This will ensure that any differences between groups will be down to intensity of exercise rather than the amount of energy expended. Following walking on a treadmill at a comfortable speed for 5 min, 24 participants (15 boys and 9 girls) completed the low-intensity exercise protocol for 10 min (walking football), rested until their heart rate had returned to baseline, and then completed the high-intensity interval exercise protocol (boxing), for 9 min. Nine minutes of the high-intensity exercise (e.g. four repetitions of 45 s of exercise and 90 s rest) was the equivalent of approximately 12 min of continuous low-intensity exercise.

Social activities will include board and team games (e.g. giant Jenga), and group discussions, with the exact activities agreed upon by the group. The purpose of these control activities is to provide a comparative length of time (to the exercise groups) and social context, which does not involve exercise, to estimate any potential social benefits for depression of the two exercise conditions. The Healthy Living session will be the same as other trial arms to avoid introducing variables other than supervised exercise sessions into the study design. Young people in all three arms will be encouraged to engage in physical activity after the intervention ends to maintain their exercise levels.

This model of delivery is based on feedback from young people, the team’s experience, and the importance of adherence [50].

Behaviour change techniques (BCT [51];) have been derived using the Behaviour Change Wheel approach, incorporating the COM-B system [52] and the Theoretical Domains Framework (TDF [53]) used as a theoretical base for the ‘Healthy Living’ component of the intervention, e.g. [54]. There are two main objectives of the 15–20 min Healthy Living sessions: (1) to help ensure the young people attend the sessions and engage with the intervention; and (2) to encourage the sustainability of physical activity engagement after the intervention has ended.

These sessions will address key BCTs, delivered through the REPs using Motivational Interviewing and Health Coaching, to promote engagement and enable young people to drive their own goals, learning, and behaviour. The BCTs will use theoretical drivers from the COM-B and TDF to target barriers and facilitators to Capability, Opportunity, and Motivation (see Table 2 for full mapping of theoretical content). Barriers, highlighted by our consultations with young people, include a lack of ‘head space’ or stamina for exercise (Psychological and Physical Capability), lack of social support (Social Opportunity), negative beliefs about exercise (Reflective Motivation), and emotions that lead to avoidance (Automatic Motivation). Potential facilitators were suitable environments (Physical Opportunity) to increase access, manageable sized groups (6–10 young people) and peer support (Social Opportunity), setting goals and increasing positive expectations about exercise (Reflective Motivation). Motivational interviewing (MI) and health coaching will be used to deliver BCTs that will target these barriers and facilitators to enhance intrinsic motivation [57, 58], and address potential depression-related barriers using aspects of behavioural activation, such as activity scheduling and reducing avoidance.

Intervention content mapped from the COM-B to the TDF, intervention functions, policy categories, and behaviour change techniques (BCTs) (based on [51, 53, 55, 56]).

1.1 Goal setting (behaviour)

1.4 Action planning

3.1 Social support (unspecified)

3.2 Social support (practical)

3.3 Social support (emotional)

The intervention sessions will be delivered primarily by a REP, with a minimum of level 3 qualifications or equivalent, contracted to local community sport and physical activity organisations. A mental health support worker (MHSW) (e.g. an assistant psychologist) will assist the REP in delivering the sessions and will be employed by the local NHS trust. Prior to attending training deliverers will complete the online Good Clinical Practice training from the NIHR [59]. The REPs and MHSWs will then attend 3 days of training (spread over approximately 4 weeks): day 1 will focus on good clinical practice, running the exercise sessions, heart rate monitoring, and research skills related to outcome assessment and data management; the second day will focus on encouraging attendance, adherence, and engagement with the sessions, and longer-term behaviour change; the third day will focus on consolidating the exercise, delivery, behaviour change, and research skill, and mental health training for physical activity promotion.

The training day on behaviour change will cover the ‘healthy living’ behaviour change session content and communication skills using motivational interviewing [60], and how to deliver the BCTs with an emphasis on expressing empathy and being client-focused [61]. This training will highlight the need to engage the young people in the discussions, resist telling them what to do (the righting reflex), allowing focus on what is desired and achievable, to understand their perspective, evoke a sense of empowerment, ensure they feel supported, and have a plan going forward [62]. Core communication skills to support effective group discussions [57, 63] such as RULE (Resist the righting reflex; Understand your client’s motivation; Listen to your client; Empower your client) and OARS (Open-ended questions, Affirmations, Reflective listening, Summaries) will be covered and linked to the delivery of the BCTs. Throughout the delivery period, the REPs and MHSWs will have four further half-day ‘supervision’ workshops to reflect on challenging and successful group discussions and to get expert and peer review of their intervention delivery.

The outcomes for this feasibility trial are:

Referral rate recorded as the number of young people referred for screening via any route by the end of recruitment

Recruitment rate recorded as the number of eligible participants who consent to participate in the study by the end of recruitment

Attrition rate recorded as the number of participants who consent to participate that do not remain in the study until the end of follow-up at 26 weeks post randomisation

Attendance rate at the intervention sessions as a proportion of the total number of sessions by 12 weeks

Heart rate as measured using a heart rate monitor at each exercise session up to 12 weeks

Physical activity measured using an accelerometer as proportion of time active at baseline, 14 weeks, and 26 weeks

Adherence to the intervention protocol as captured by the intervention logs and rated against the adherence checklist by members of the study team at weekly intervention sessions and at 14 and 26 weeks

Proportion of missing data will be reported as the percentage of recorded outcomes against those expected after account for withdrawal for each outcome separately at 26 weeks

Adverse event rate recorded as the frequency, type (injury or clinical progression of depression), and severity of event by treatment arm at 26 weeks

Estimate of resource use as measured through observation and study-specific questionnaire at 26 weeks

Reach and representativeness measured by the proportions of young people who are screened for participation and are randomised in comparison to the characteristics of local populations by the end of recruitment

A traffic-light system, relating to recruitment, retention, adherence, and completion will inform whether we “stop”, “proceed”, or “proceed but with protocol changes” [64]. This system will be judged on criteria including young people’s attendance at sessions > 66% and questionnaire completion > 80% at 14 weeks. Additional process evaluation outcomes are the acceptability of the interventions and questionnaires, barriers and facilitators to engagement of young people, evaluating recruitment methods, and adherence to the intervention protocol by deliverers (fidelity).

Figure 1 shows the flowchart detailing study processes, highlighting the stages leading from participant eligibility assessment to final data analysis.

Study flowchart

Eighty-one eligible young people from three English counties (27/county; Hertfordshire, Bedford, and Norfolk) were selected. This sample size was selected to enable 20 participants per arm to attend the intervention sessions (assuming 33% dropout) and allows for each of the 3 interventions to be completed at each of the 3 study sites, giving 9 groups in total. Each group needs to have 9 participants to ensure that at any given session at least 6 participants are present (allowing for 33% no show/drop out). As this is a feasibility study it is not powered to detect a difference in clinical outcomes between the two intervention arms and the social control arm. Therefore, no power calculation has been performed. A sample size of 81 participants will allow us to gain experience in running each intervention at each site. It will also allow us to estimate the outcome completion rate to within ± 6% assuming a completion rate of 80% using an 80% confidence interval.

Young people will be recruited from Child and Adolescent Mental Health Services (CAMHS; Tiers 2 and 3), other Tier 2 services, and GP practices (Tier 1). Tier 2 services may be provided by NHS Trusts, but in some areas they are provided by the third sector (e.g. in Norfolk and Suffolk, Point 1 provide these services). The main organisation at each site is likely to be CAMHS (with responsibility to ensure clinical safety), with independent Tier 2 and GP practices acting as participant identification centres (PIC). The English counties involved are Hertfordshire (Hertfordshire Partnership University NHS Foundation Trust and Hertfordshire Community Trust), Norfolk (Norfolk & Suffolk NHS Foundation Trust), and Bedford (East London NHS Foundation Trust). These sites will be involved in recruitment to the study including screening and gaining consent from participants and collection of study outcome measures at baseline and follow-up. Effort was made to base the study across counties that would broaden the characteristics of the sample in terms of race/ethnicity and indices of deprivation.

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