Plain English Summary
Background and study aims
Sleep problems and mental health complaints go hand-in-hand, with sleeping problems associated with many, if not all, mental health problems. This association is particularly apparent between insomnia (problems falling to sleep and staying asleep) and feelings of paranoia (when a person believes that harm is occurring, or is going to occur, to him or her, and that the persecutor has the intention to cause harm). Indeed, both sleeping problems and paranoid thinking are relatively common in both those with a clinical diagnosis and in the general population. This association raises an intriguing possibility that the present study aims to explore: can interventions for insomnia lead to improvements in paranoia? To answer this question, the aim of this study is to test the impact of a self-help intervention designed to improve insomnia on paranoia and associated experiences such as depression, stress and anxiety. The prediction is that by improving insomnia and helping people sleep better, they will also experience less paranoia alongside reduced feelings of depression, stress and anxiety.
Who can participate?
Anyone over the age of 18
What does the study involve?
Participants are randomly allocated to one of three groups: the intervention group, a sleep diary group, and a waiting list group. Participants in the intervention group are asked to log into the intervention website and follow the instructions presented to them. They complete six modules over 6 weeks, each offering information and practical exercises to help them to sleep better. These participants are also asked to complete a daily sleep diary to record the times that they go to bed and get up each day, the number of times that they wake each night, how they feel in the morning (ranging from 1 – ‘very tired’ to 5 – ‘very refreshed’), and their caffeine consumption. Participants who complete the daily sleep diary can access their responses on the intervention website in a section called ‘Sleep Stats’. Here their responses are displayed using graphs, tables and charts so that participants can track their progress throughout the study. Participants in the sleep diary group complete the same sleep dairy for 6 weeks, but do not have access to any other aspect of the intervention. Participants in the waiting list group receive no intervention in the first instance so that we can compare the effects of the intervention to doing nothing at all. However, after the study has finished, participants in the waiting list group are offered access to the full intervention. Levels of insomnia, paranoia, depression, stress and anxiety are measured before the intervention started, immediately after the intervention, and 4- and 18-weeks after the intervention.
What are the possible benefits and risks of participating?
Participants benefit from receiving an online insomnia intervention for free, which may help them to improve their sleep and access information about their sleep. Participants also benefit from contributing to research that may help patients in the future. There are no risks involved in this study.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
April 2014 to August 2015
Who is funding the study?
Investigator funded
Who is the main contact?
Dr Alexander Scott
Trial website
Contact information
Type
Public
Primary contact
Dr Alexander Scott
ORCID ID
http://orcid.org/0000-0001-7426-7099
Contact details
ScHARR
The University of Sheffield
30 Regent Court
Sheffield
S1 4DA
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The relationship between insomnia, negative affect, and paranoia: a parallel-group randomised controlled trial
Acronym
Study hypothesis
An online, cognitive behavioural therapy based intervention for insomnia will lead to reductions in negative affect and paranoia.
Ethics approval
Research Ethics Committee in the Department of Psychology at the University of Sheffield, 15/01/2014
Study design
Parallel-group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Insomnia, paranoia, negative affect
Intervention
Participants are randomised into three groups: the intervention group; a group who completed only a daily sleep diary (active control); and a wait-list control group who received nothing. All participants in each group were in the trial for a total of 24 weeks (6 week intervention delivery period followed by follow-up points at 4-weeks and 18-weeks post intervention)
The intervention group received the full, 6-week CBT intervention designed to target factors that contribute to the formation and maintenance of insomnia, adapted from that developed by Lancee, van den Bout, van Straten and Spoormaker (2012). The intervention was self-administered via a website (i.e., did not involve any contact with the researchers) and provided psychoeducational materials detailing good sleep hygiene practices and information about sleep, as well as exercises based on the principles of CBT that aimed to challenge common misconceptions and maladaptive thought processes about sleep. Participants in this group also completed a daily sleep diary documenting how they slept the previous night. The diary asked them to record the times that they went to bed and got up each day, the number of times that they woke each night, how they felt in the morning (ranging from 1 – ‘very tired’ to 5 – ‘very refreshed’) and caffeine consumption. Participants who completed the daily sleep diary were able to access their responses on the intervention website in a section called ‘Sleep Stats’. Here their responses were collated and visualised (e.g., using graphs, tables, charts etc.) so that participants could track their progress throughout the trial.
The sleep diary group completed only the sleep diary aspect of the intervention described above. They did not have access to sleep hygiene information or the CBT content.
The wait-list control group received no intervention whatsoever (however they were offered access to the full intervention after the final follow-up point).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Sleep-50 insomnia sub-scale: assessing aspects of insomnia (both falling asleep and staying asleep)
Each of the outcome measures were completed by all participants before the intervention started (baseline), immediately after the intervention (post-intervention), 4-weeks after the intervention and finally 18 weeks after the intervention
Secondary outcome measures
1. Depression, Anxiety, and Stress Scale-21 (DASS-21): the shortened form of DASS-21 assessing feelings of depression, anxiety and stress, collectively referred to as negative affect
2. Green Paranoid Thoughts Scale part B (GPTS-B): measuring levels of paranoid thinking
Each of the outcome measures were completed by all participants before the intervention started (baseline), immediately after the intervention (post-intervention), 4-weeks after the intervention and finally 18 weeks after the intervention
Overall trial start date
01/04/2014
Overall trial end date
17/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants must be over the age of 18
Participant type
All
Age group
Adult
Gender
Both
Target number of participants
324
Participant exclusion criteria
1. Under the age of 18
2. Insomnia due to a physical complaint (e.g. back pain)
3. On medication for a mental health problem or sleep complaint
4. Currently receiving psychological therapy
Recruitment start date
11/04/2014
Recruitment end date
20/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
S10 2TP
United Kingdom
Sponsor information
Organisation
University of Sheffield
Sponsor details
Department of Psychology
Western Bank
Sheffield
S10 2TP
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish the findings of this trial in a peer-reviewed journal
Intention to publish date
17/08/2016
Participant level data
Available on request
Basic results (scientific)
Publication list