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The relationship between insomnia, negative affect, and paranoia

The relationship between insomnia, negative affect, and paranoia: a parallel-group randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18384206
Enrollment
324
Registered
2016-08-11
Start date
2014-04-11
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, paranoia, negative affect Mental and Behavioural Disorders

Interventions

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-week

Sponsors

University of Sheffield
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants must be over the age of 18

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Contacts

Public ContactAlexander Scott

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026