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Online Self-Help Intervention for Insomnia: With or Without Feedback

U

Utrecht University

Status and phase

Completed
Phase 3

Conditions

Insomnia

Treatments

Behavioral: CBT for insomnia

Study type

Interventional

Funder types

Other

Identifiers

NCT01456637
FPG-20106524

Details and patient eligibility

About

The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

Enrollment

262 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Insomnia
  • Access to internet
  • Dutch citizen

Exclusion criteria

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

262 participants in 2 patient groups

CBT for insomnia with feedback
Experimental group
Description:
In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.
Treatment:
Behavioral: CBT for insomnia
CBT for insomnia without feedback
Experimental group
Description:
In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.
Treatment:
Behavioral: CBT for insomnia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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