CClinicalTrials.gg
CompletedNCT02599597Updated Mar 4, 2020

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

An interventional study of Therapist-assisted iCBT and Monthly screening with feedback in Depression, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Lund University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Depression
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 150 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Fulfilling the criteria for Major depression
  • Bipolar disorder
  • Psychosis
  • Substance abuse
  • Suicidality
  • Currently in psychotherapy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Therapist-assisted iCBT

    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 iCBT · Behavioral: Monthly screening with feedback

  • Active comparator
    Monthly screening with feedback

    Monthly depression screening with therapist feedback.

    Behavioral: Monthly screening with feedback

  • No intervention
    Control

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

Interventions

  • BehavioralTherapist-assisted iCBT

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

  • BehavioralMonthly screening with feedback

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline - 12 months

  2. 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.

    Time frame: Baseline - 6 months

  3. 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.

    Time frame: Baseline - 12 months

  4. 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.

    Time frame: Monthly, 0-12 months

Secondary outcomes

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

    Health related quality of life will be measured by an internet based version of the EQ-5D.

    Time frame: Baseline - 3 months

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

    Health related quality of life will be measured by an internet based version of the EQ-5D.

    Time frame: Baseline - 6 months

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

    Health related quality of life will be measured by an internet based version of the EQ-5D.

    Time frame: Baseline - 9 months

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

    Health related quality of life will be measured by an internet based version of the EQ-5D.

    Time frame: Baseline - 12 months

  5. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.

    Time frame: Baseline - 3 months

  6. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.

    Time frame: Baseline - 6 months

  7. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.

    Time frame: Baseline - 9 months

  8. Change from baseline in Outcomes Questionnaire 45 (OQ-45)

    The OQ-45 measures functioning in 3 domains: Symptom distress (heavily loaded for depression and anxiety), Interpersonal functioning, and Social Role. It enables the clinician to assess functional level and change over time.

    Time frame: Baseline - 12 months

  9. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire is a measure of physical activity

    Time frame: Baseline - 3 months

  10. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire is a measure of physical activity

    Time frame: Baseline - 6 months

  11. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire is a measure of physical activity

    Time frame: Baseline - 9 months

  12. Change from baseline in the International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire is a measure of physical activity

    Time frame: Baseline - 12 months

  13. Morisky Medication Adherence Scale (MMAS-8)

    Self-reported measure of medication adherence

    Time frame: Baseline - 3 months

  14. Morisky Medication Adherence Scale (MMAS-8)

    Self-reported measure of medication adherence

    Time frame: Baseline - 6 months

  15. Morisky Medication Adherence Scale (MMAS-8)

    Self-reported measure of medication adherence

    Time frame: Baseline - 9 months

  16. Morisky Medication Adherence Scale (MMAS-8)

    Self-reported measure of medication adherence

    Time frame: Baseline - 12 months

  17. Insomnia Severity Index (ISI)

    Insomnia issues

    Time frame: Baseline - 3 months

  18. Insomnia Severity Index (ISI)

    Insomnia issues

    Time frame: Baseline - 6 months

  19. Insomnia Severity Index (ISI)

    Insomnia issues

    Time frame: Baseline - 9 months

  20. Insomnia Severity Index (ISI)

    Insomnia issues

    Time frame: Baseline - 12 months

  21. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 3 months

  22. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 6 months

  23. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 9 months

  24. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline - 12 months

  25. Time to depressive relapse

    Time to depressive relapse is recorded as secondary outcome variable

    Time frame: Baseline - 12 months

  26. Self reported treatment seeking

    Treatment seeking among participants is recorded as secondary outcome variable

    Time frame: Baseline - 12 months

07

Study locations

1 site
  • Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
    Malmö, Skåne 21431, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02599597
Lead sponsor
Lund University
Responsible party
Olof Johansson (PhD student, Lund University) — Principal investigator
First posted
Nov 6, 2015
Start date
Feb 2016
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Mar 4, 2020

Study contacts

Lars-Gunnar Lundh, Professor
principal investigator · Lund University, Departement of psychology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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