Headspace as a guided self-help mindfulness course for depression

The purpose of using outcome measures in feasibility studies is to investigate and evaluate a number of processes related to the intervention (intervention recruitment, retention, acceptability and preliminary indicators of effectiveness), rather than outcomes related to the effectiveness of the intervention. As such, feasibility studies need not include a primary outcome measure.

Outcomes will be reported as follows:

1. Number of people meeting inclusion criteria in the participating IAPT services and offered the study.
2. Of 1), the number of people consenting to take part in the study
3. Reasons for not agreeing to take part in the study (recorded by practitioners conducting initial assessments)
4. Demographics (gender, age, ethnicity) of people who decline to take part in the study. This information is asked as part of the routine initial assessment and will be recorded by practitioners conducing initial assessments and fed back to the research team.
5. Number of people completing the intervention (defined as listening to the guided mindfulness practices on at least 24 out of 30 sessions within 8 weeks, i.e., 80% of sessions completed). Usage data is collected automatically by the Headspace app.
6. Number of people attending at least 3 PWP sessions
7. Reasons for dropping out of the intervention (recorded by participants when completing post-intervention measures or by practitioners at the IAPT service)
8. Helpful and/or engaging aspects of the intervention (participants’ views). This will be recorded by participants when completing post-intervention measures (using open text boxes) and through qualitative telephone interviews with 10 participants conducted after the study by the RA (details below).
9. Helpful and/or engaging aspects of the intervention (PWP views). This will be recorded after the study by inviting PWPs to complete an anonymous online questionnaire (using open text boxes).
10. Unhelpful aspects of the intervention and/or barriers to engagement (participants’ views). This will be recorded by participants when completing post-intervention measures (using open text boxes) and through telephone interviews conducted after the study by the RA with 10 participants (details below).
11. Unhelpful aspects of the intervention and/or barriers to engagement (PWP views). This will be recorded after the study by inviting PWPs to complete an anonymous online questionnaire (using open text boxes)
12. Barriers and enablers to IAPT implementation (IAPT service lead/manager views). This will be recorded after the study by inviting IAPT service lead/manager to complete an anonymous online questionnaire (using open text boxes)
13. Pre-intervention to post-intervention Cohen’s d effect sizes and 95% confidence interventions on the primary effectiveness outcome (PHQ-9), secondary outcomes (GAD-7, SWEMWBS), and proposed mechanisms (FFMQ-15, SCS-SF, PSWQ, RRS). Details of these self-report measures are given below
14. Participant demographics (gender, age, ethnicity, marital status, level of education, previous experience of mindfulness) will be recorded at pre-intervention in order to describe the sample of participants

Self-report measures (administered twice unless otherwise noted: at pre-intervention and post-intervention):
1. Depression symptom severity (PHQ-9; Kroenke & Spitzer, 2002): 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 from 0 to 3. Scores under 10 are considered sub-clinical, 10-14 moderate, 15-19 moderately severe, and 20 or over severe. As well as being administered at baseline and post-intervention, this scale will be administered at each PWP session
2. Anxiety severity (GAD-7; Spitzer et al., 2006): the GAD-7 is a 7-item measure of the severity of generalised anxiety disorder. Items are rated on a four-point Likert scale from 0 to 3. Scores between 5-9 are considered to indicate mild anxiety, 10-14 moderate anxiety, and 15 and over severe anxiety. As well as being administered at baseline and post-intervention, this scale will be administered at each PWP session
3. Wellbeing: this will be measured using the Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS; Stewart-Brown et al., 2009)
4. Mindfulness: this will be measured using the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15; Baer et al., 2008)
5. Self-compassion: this will be measured using the 12-item short form of the Self-Compassion Scale (SCS-SF; Raes et al., 2011)
6. Worry: This will be measured using the 16-item Penn State Worry Questionnaire (Meyer et al., 1990)
7. Rumination: This will be measured using the 10-item Ruminative Responses Scale (Treynor et al., 2003)
8. System Usability Scale (Brooke, 1996): This 10-item measure (adapted to refer to Headspace) will be administered at post-intervention only to assess the usability of Headspace
9. PWP Rating Scale: This 4-item scale, adapted from the Session Rating Scale (Duncan et al., 2003), will be administered at post-intervention only to assess participants’ experience of the PWP-lead support sessions
10. Intervention Expectation Form: This 6-item measure will be administered at baseline only to assess participants’ expectations of Headspace
11. Lasting Effects Questionnaire: This questionnaire, adapted from Crawford et al. (2016), will be administered at post-intervention only to assess any negative effects resulting from using Headspace
12. Work and Social Adjustment Scale (Mundt et al., 2002): This 5-item self-report scale measures functional impairment attributable to an identified problem. This scale will not be recorded at baseline and post-intervention; it will be administered at each PWP session only

No secondary outcome measures.