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ID
Source
Health condition
Well-being, depression, anxiety
Sponsors and support
Intervention
Outcome measures
Primary outcome
Well-being, measured with the Mental Health Continuum-Short Form (MHC-SF), timepoints: baseline, 3/6/12 months
Secondary outcome
Secondary outcomes:
- Stress, measured with the Perceived Stress Scale (PSS-10), timepoints: baseline, 3/6/12 months
- Depression, measured with the HADS-D, timepoints: baseline, 3/6/12 months
- Anxiety, measured with the HADS-A, timepoints: baseline, 3/6/12 months
Process variables/mediators:
- Self-compassion, measured with the Self-Compassion Scale-Short Form (SCS-SF), timepoints: baseline, 3/6/12 months
- Self-criticism and self-reassurance, measured with the Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS), timepoints: baseline, 3/6/12 months
- Positive and negative emotions, measured with the Positive and Negative Affect Schedule-Short Form (PANAS-SF), timepoints: baseline, 3/6/12 months
- Gratitude, measured with the Gratitude Questionnaire (GQ-6), timepoints: baseline, 3/6/12 months
Tertiair outcomes (to assess cost-effectiveness):
- Absenteeism and production losses, measured with six items from the Productivity and Disease Questionnaire (Prodisq), timepoints: baseline, 3 and 6 months
- Healthcare use, measured with 2 items from the questionnaire for healthcare use and production losses among psychological disorders (Tic-P), timepoints: baseline, 3 and 6 months
Additional variables:
- Socio-demographic characteristics (e.g. sex, age, education level, marital status), timepoints: baseline
- Positive and negative life events in the past 12 months, timepoints: baseline and 12 months
- Evaluation questionnaire concerning the duration and contents of the self-compassion intervention as well as the e-mail support, timepoints: 3 months (solely in the experimental condition)
Background summary
The effectiveness of a self-compassion based self-help intervention, with weekly e-mail guidance, in terms of well-being will be tested in a Randomised Controlled Trial (RCT) with two conditions: 1) an experimental condition, receiving the intervention, and 2) a waitlist control condition (who will receive the intervention after 6 months). The intervention is primarily based on compassion focused therapy and consists of a self-help book (7 lessons) and weekly email guidance. The email guidance is provided by two graduated psychologists and two Master students psychology, under supervision of a clinical psychologist. Anticipating a dropout rate of 20%, 206 adults (18 years or older) with mild to moderate levels of well-being will be recruited from the Dutch general population (103 per condition). There will be four measurements by means of online questionnaires: at baseline and 3, 6 and 12 months after baseline. The primary outcome measure is well-being. Secondary-outcome measures include stress, depression and anxiety. Mediators are self-compassion, self-criticism, self-reassurance, positive and negative emotions and gratitude. Also socio-demographics will be gathered, as well as data in the context of a cost-effectiveness analysis.
Study objective
The primary aim is to test the effectiveness of a self-compassion based guided self-help intervention in improving well-being, compared to a waitlist control group. It is hypothesised that the self-compassion based self-help intervention is superior to the waitlist control group.
Study design
Over a course of 1 year, there are 4 assessment times:
- Before the start of the intervention (T0, baseline)
- 3 months after baseline (T1)
- 6 months after baseline (T2)
- 12 months after baseline (T3)
Measurements will be conducted by means of online questionnaires.
Intervention
We will carry out a two-arm RCT with people (recruited from the general population in the Netherlands) randomly assigned to (1) self-compassion based self-help intervention, and (2) waitlist control group. Whereas participants in the experimental condition will receive the intervention immediately following randomisation, participants in the control condition will be placed on a waiting list and receive the intervention after 6 months.
The intervention is aimed at promoting well-being through strengthening people's abilities for self-compassion. It consists of a self-help book, based on compassion-focused therapy, with weekly email guidance.
The book has seven chapters. Each chapter (or module) deals with an important aspect of self-compassion and consists of both introductory texts and specific exercises.
Examples of themes include: self-criticism and self-compassion, emotion systems, resources for self-compassion, and developing kindness to oneself and others. Participants will be instructed to read one module per week in sequential order, and practise the recommended exercises of that module. Participants will have 7 – 9 weeks to complete the seven modules of the book to take holidays and other circumstances into account. Participants will receive email support after they have completed each module (seven times in total). On average, participants in the experimental group are expected to invest at least 2 to 4 hours per week during the intervention period.
Email counselling is performed by two master students psychology and two graduated psychologists, who are under supervision of a clinical psychologist. The main goal of the email support is to encourage the participants to read the scheduled modules and practise the recommended exercises. The participants will be asked to introduce themselves before the email sessions start. Participants are asked to send a weekly email at a fixed day in the week wherein they write about their experiences with the scheduled module and exercises. Within 2-3 days after receiving this email, the personal counselors will answer the emails. The counselors will be instructed to give feedback, paraphrase, motivate and ask questions about the progression of participants (e.g. “I read that you have invested quite some time in the recommended exercises of this week.”, “Could it be helpful for you to practise this exercise more regularly?”, “What have you discovered when you performed the exercises?”). Counselors will use positive reinforcement for signs of awareness, insights, improvement and change (e.g. “This seems a valuable experience for you, how exactly did you achieve that?, “What will be a next sign of progress?”, “That seems a helping thought to you.”). When there are reasons to assume that a participant has serious complaints, the participant will be referred to a general practitioner or a health care specialist. In an attempt to reduce intervention drop-out, reminders will be send to participants who do not send an email to their counselor.
Faculteit der Gedragswetenschappen | Vakgroep Psychologie, Gezondheid en Technologie |
Marion Spijkerman
Drienerlolaan 5 (Cubicus, kamer C140)
Enschede 7500 AE
The Netherlands
053 - 489 6545
m.p.j.spijkerman@utwente.nl
Faculteit der Gedragswetenschappen | Vakgroep Psychologie, Gezondheid en Technologie |
Marion Spijkerman
Drienerlolaan 5 (Cubicus, kamer C140)
Enschede 7500 AE
The Netherlands
053 - 489 6545
m.p.j.spijkerman@utwente.nl
Inclusion criteria
- Age 18 years or older
- Experiencing a low to moderate level of well-being, as determined by the Mental Health Continuum-Short Form (MHC-SF) (“languishers” or “moderately mentally healthy”)
- Access to a computer or tablet/iPad and a good Internet connection
- Possessing an e-mail address
- Sufficient proficiency of the Dutch language
- Able and willing to provide informed consent
Exclusion criteria
- Experiencing a high level of well-being ("flourishers"), as determined by the MHC-SF
- Moderate to severe depression and/or anxiety, as determined by the Hospital Anxiety and Depression Scale (score > 11 on HADS-A and/or HADS-D)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5304 |
| NTR-old | NTR5413 |
| Other | : Not applicable |