Table 4 Timing and purpose of changes to protocol

RSES replaced RSQ

17/2/20

Pre-registration

To improve methods (e.g., in light of new information)

CIPD replaced SCID

17/2/20

Pre-registration

To reduce or save research costs

BCSS added

17/2/20

Pre-registration

To improve methods (e.g., in light of new information)

CSRI added

17/2/20

Pre-registration

To improve methods (e.g., in light of new information)

Randomisation sequence parameters changed

17/2/20

Pre-registration

To improve methods (e.g., in light of new information)

English docs updated with Scottish REC changes

26/9/20

Pre-randomisation

To align English & Scottish REC approved protocols

COVID-19 information sheet introduced

3/12/20

Pre-randomisation

To mitigate pandemic health risks

Remote consent introduced

3/12/20

Pre-randomisation

To mitigate pandemic health risks

Remote clinical procedures introduced

3/12/20

Pre-randomisation

To mitigate pandemic health risks

Remote research assessments introduced

3/12/20

Pre-randomisation

To mitigate pandemic health risks

COVID-19 protocol introduced

3/12/20

Pre-randomisation

To mitigate pandemic health risks

Newspaper recruitment advert launched

8/2/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment

Bus stop recruitment adverts launched

17/5/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment

Recruitment window in Lothian extended

1/7/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment

Lothian research staff reduced

1/7/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment via rebudgeting of research costs

English site opening delayed (without extending recruitment window)

1/7/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment

Independent statistician replaced by PJT

1/7/21

Post 1st randomisation

To mitigate the effect of the pandemic on recruitment via rebudgeting of research costs

CIPD dropped at 8 and 24 weeks

1/7/21

Post 1st randomisation

To fix an error

English site closure delayed (without extending recruitment window)

8/6/22

Post 1st randomisation

To mitigate the effects of NHS staffing problems and the pandemic on recruitment

Recruitment window in Lothian extended

8/6/22

Post 1st randomisation

To mitigate pandemic health risks, its effects on recruitment, and the effect of NHS staffing problems

More than 20 participants allowed to participate in self-stigma or jumping to conclusions trials

20/8/22

Post 1st randomisation

To mitigate the effects of the pandemic and low prevalence of self-esteem on recruitment, and to ensure best use of research and treatment costs

Preferential allocation to self-esteem trial introduced

20/8/22

Post 1st randomisation

To mitigate the impact of the low prevalence of low self-esteem on recruitment

Previous participants allowed to return to take part in 1 of the other trials (if eligible)

20/8/22

Post 1st randomisation

To mitigate the effects of the pandemic and low prevalence of self-esteem on recruitment, and to ensure best use of research and treatment costs

Randomisation to treatment or control allowed to happen before clinical session 1 in some cases

27/9/22

Post 1st randomisation

To improve feasibility

Lothian sample size increased by 1 (45 to 46)

6/10/22

Post 1st randomisation

To fix an error

Study end date extended in all sites (without extending recruitment window)

6/10/22

Post 1st randomisation

To mitigate the effect of NHS staffing problems and to complete other tasks