NCT02599597

Brief Summary

Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. This study evaluates the potential of these methods as prevention of depressive relapse or recurrence

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

November 5, 2015

Last Update Submit

March 3, 2020

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

  • Depressive relapse (change in diagnostic status, SCID-I)

    Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated \& Structured Clinical Interview for DSM IV

    Baseline - 12 months

  • Change from baseline in depressive symptoms (MADRS-S)

    Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

    Baseline - 6 months

  • Change from baseline in depressive symptoms (MADRS-S)

    Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

    Baseline - 12 months

  • Change from baseline in depressive symptoms (MADRS-S)

    Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

    Monthly, 0-12 months

Secondary Outcomes (26)

  • Change from baseline in health related quality of life (EQ-5D)

    Baseline - 3 months

  • Change from baseline in health related quality of life (EQ-5D)

    Baseline - 6 months

  • Change from baseline in health related quality of life (EQ-5D)

    Baseline - 9 months

  • Change from baseline in health related quality of life (EQ-5D)

    Baseline - 12 months

  • Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    Baseline - 3 months

  • +21 more secondary outcomes

Study Arms (3)

Therapist-assisted iCBT

EXPERIMENTAL

Internet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.

Behavioral: Therapist-assisted iCBTBehavioral: Monthly screening with feedback

Monthly screening with feedback

ACTIVE COMPARATOR

Monthly depression screening with therapist feedback.

Behavioral: Monthly screening with feedback

Control

NO INTERVENTION

No intervention, follow-up along with all participants at 6 and 12-months.

Interventions

Therapist-assisted iCBTBEHAVIORAL

13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.

Therapist-assisted iCBT
Monthly screening with feedbackBEHAVIORAL

Participants are screened with a depression inventory each month and receives feedback from a therapist on the results

Monthly screening with feedbackTherapist-assisted iCBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of at least one episode of Major Depression.
  • If medicating - 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
  • Bipolar disorder
  • Psychosis
  • Substance abuse
  • Suicidality
  • Currently in psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö

Malmo, Skåne County, 21431, Sweden

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Lars-Gunnar Lundh, Professor

    Lund University, Departement of psychology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 6, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

SE(1)