Condition category
Mental and Behavioural Disorders
Date applied
09/08/2016
Date assigned
11/08/2016
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.sheffield.ac.uk/psychology/index

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes