Internetbased Relapse Prevention for Partially Remitted Depression

NCT01807988 | Unknown

• 1 other identifier: 2012/488
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention:

• The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group.
• Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group.
• The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group.
• At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.

Conditions

Depression

Keywords

Relapse, Recurrence, Depression, Internet, Sick-leave

Outcome Measures

Primary Outcomes (4)

• Days absent from work due to sick leave

  The total number of days that a participant has been absent from work due to sick leave (any cause). Data will be collected from the National Insurance Agency at the end of the study.

  24 month follow up

• Change in self-reported sick leave days

  Self-reported number of sick leave days during the study will be collected cumulatively every month during the study time and summarised after 24 months.

  After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months

• Change in diagnostic status

  Change in diagnostic status (depressive relapse) will be assessed in a telephone interview every month during the study. The definition of a relapse is to fulfill the diagnostic criteria for major depression according to the DSM-IV at any time after the study start.

  After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months

• Change in depressive symptoms

  Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. The patient will fill out the questionnaire every month.

  After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months

Secondary Outcomes (2)

• Change in health related quality of life

  After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months

• Change in costs associated with illness

  Pre- and post treatment, after 12 and 24 months

Study Arms (2)

iCBT

EXPERIMENTAL

Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression.

Behavioral: iCBT

Control group

NO INTERVENTION

The control group in the study will fill out questionnaires every month and will be interviewed every month to detect any relapses. They will also receive feedback on there self-reported symptoms.

Interventions

iCBT BEHAVIORAL

Internetbased cognitive behavior therapy (iCBT) contains interventions that will help the participant to change her behavior to experience more positive reinforcement in daily life and also to challenge her negative patterns of thought. There are also information and exercices to improve sleep, increase physical activity, train mindfulness, handle anxiety and to learn about depression.

iCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild residual depressive symptoms (7-19 on the MADRS-S).
• A history of at least one episode of Major Depression.
• Currently in (at least) half-time employment, self-employment or education.
• Taking a stable (since one month) and therapeutic dosage of antidepressant medication
• Being able to read and write Swedish
• Having access to the internet

You may not qualify if:

• Fulfilling the criteria for Major depression
• Psychosis
• Substance abuse
• Suicidality

Sponsors & Collaborators

• Örebro County Council: lead
• Uppsala University: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (2)

Psychiatric Research Centre

Örebro, 70116, Sweden

NOT YET RECRUITING

Psychiatric Clinic in Uppsala

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Depression; Recurrence

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fredrik Holländare, PhD

CONTACT

+46737600700; fredrik.hollandare@orebroll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, PhD

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

SE (2)