DepressionNCT02599597

Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

A study testing Therapist-assisted iCBT and Monthly screening with feedback in people with Depression, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Therapist-assisted iCBT and Monthly screening with feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteSweden
Study dates: Feb 2016to 1 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Vuxenpsykiatrimottagning allmänpsykiatri Fosievägen Malmö
Malmö, Skåne County, 21431

Other trials in Sweden

About this study

Conditions: Depression
Being tested: Therapist-assisted iCBT, Monthly screening with feedback
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapist-assisted iCBTBehavioural
13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
Monthly screening with feedbackBehavioural
Participants are screened with a depression inventory each month and receives feedback from a therapist on the results

Study groups in NCT02599597
Study group	Role	What they receive
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. Receives: Behavioral: Therapist-assisted iCBT; Behavioral: Monthly screening with feedback
Monthly screening with feedback	Active comparator	Monthly depression screening with therapist feedback. Receives: Behavioral: Monthly screening with feedback
Control	No intervention	No intervention, follow-up along with all participants at 6 and 12-months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Depressive relapse (change in diagnostic status, SCID-I)
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated \& Structured Clinical Interview for DSM IV
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Monthly, 0-12 months

Secondary outcomes (26)

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.
Measured: Baseline - 3 months
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.
Measured: Baseline - 6 months
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.
Measured: Baseline - 9 months
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.
Measured: Baseline - 12 months
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.
Measured: Baseline - 3 months
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.
Measured: Baseline - 6 months
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.
Measured: Baseline - 9 months
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.
Measured: Baseline - 12 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Measured: Baseline - 3 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Measured: Baseline - 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Measured: Baseline - 9 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity
Measured: Baseline - 12 months
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Measured: Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Measured: Baseline - 6 months
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Measured: Baseline - 9 months
Morisky Medication Adherence Scale (MMAS-8)
Self-reported measure of medication adherence
Measured: Baseline - 12 months
Insomnia Severity Index (ISI)
Insomnia issues
Measured: Baseline - 3 months
Insomnia Severity Index (ISI)
Insomnia issues
Measured: Baseline - 6 months
Insomnia Severity Index (ISI)
Insomnia issues
Measured: Baseline - 9 months
Insomnia Severity Index (ISI)
Insomnia issues
Measured: Baseline - 12 months
Alcohol Use Disorder Identification Test (AUDIT)
Measured: Baseline - 3 months
Alcohol Use Disorder Identification Test (AUDIT)
Measured: Baseline - 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Measured: Baseline - 9 months
Alcohol Use Disorder Identification Test (AUDIT)
Measured: Baseline - 12 months
Time to depressive relapse
Time to depressive relapse is recorded as secondary outcome variable
Measured: Baseline - 12 months
Self reported treatment seeking
Treatment seeking among participants is recorded as secondary outcome variable
Measured: Baseline - 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20161 Dec 2019

First posted6 Nov 2015 (estimated)
Study startFeb 2016
Primary completion1 Dec 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Lund UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02599597
Sponsor's protocol ID: rel-prev
Status last verified: Mar 2020
First submitted: 5 Nov 2015
Last updated: 4 Mar 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle
ClinicalTrials.gov ID: NCT02599597
Acronym / sponsor ID: rel-prev
Conditions: Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Lund UniversityUniversity, hospital or other
Study start: Feb 2016
Primary completion: 1 Dec 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 6 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Therapist-assisted iCBT	Experimental	Behavioral: Therapist-assisted iCBT, Behavioral: Monthly screening with feedbackInternet-delivered cognitive behavioral therapy (iCBT), containing physical activity and sleep management for preventing depressive relapse. Monthly depression screening with therapist feedback.
Monthly screening with feedback	Active comparator	Behavioral: Monthly screening with feedbackMonthly depression screening with therapist feedback.
Control	No intervention	–No intervention, follow-up along with all participants at 6 and 12-months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

Fulfilling the criteria for Major depression
Bipolar disorder
Psychosis
Substance abuse
Suicidality

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Therapist-assisted iCBT13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.	Behavioural	Therapist-assisted iCBT
Monthly screening with feedbackParticipants are screened with a depression inventory each month and receives feedback from a therapist on the results	Behavioural	Monthly screening with feedback, Therapist-assisted iCBT

Primary outcome

Depressive relapse (change in diagnostic status, SCID-I)
Time frame: Baseline - 12 months
Monthly screening via Montgomery-Asberg Depression Rating Scale - Self rated \& Structured Clinical Interview for DSM IV
Change from baseline in depressive symptoms (MADRS-S)
Time frame: Baseline - 6 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Change from baseline in depressive symptoms (MADRS-S)
Time frame: Baseline - 12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.
Change from baseline in depressive symptoms (MADRS-S)
Time frame: Monthly, 0-12 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated.

26 secondary outcomes

Change from baseline in health related quality of life (EQ-5D)
Time frame: Baseline - 3 months
Change from baseline in health related quality of life (EQ-5D)
Time frame: Baseline - 6 months
Change from baseline in health related quality of life (EQ-5D)
Time frame: Baseline - 9 months
Change from baseline in health related quality of life (EQ-5D)
Time frame: Baseline - 12 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time frame: Baseline - 3 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time frame: Baseline - 6 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time frame: Baseline - 9 months
Change from baseline in Outcomes Questionnaire 45 (OQ-45)
Time frame: Baseline - 12 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline - 3 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline - 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline - 9 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline - 12 months
Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline - 3 months
Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline - 6 months
Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline - 9 months
Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline - 12 months
Insomnia Severity Index (ISI)
Time frame: Baseline - 3 months
Insomnia Severity Index (ISI)
Time frame: Baseline - 6 months
Insomnia Severity Index (ISI)
Time frame: Baseline - 9 months
Insomnia Severity Index (ISI)
Time frame: Baseline - 12 months
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline - 3 months
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline - 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline - 9 months
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline - 12 months
Time to depressive relapse
Time frame: Baseline - 12 months
Self reported treatment seeking
Time frame: Baseline - 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.

Related trials for Depression

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Unified Protocol in Penitentiary Facilities
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lars-Gunnar Lundh, Professor principal investigator

Lund University, Departement of psychology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Therapist-assisted iCBT and Monthly screening with feedback in people with Depression, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive relapse (change in diagnostic status, SCID-I) (time frame: Baseline - 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.