Major DepressionNCT02648165
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
A study testing Attention Bias Modification and Acceptance and Commitment Therapy in people with Major Depression, run by Sorlandet Hospital HF at 2 sites in Norway.
Trial summary
Depression (major depressive disorder; MDD) is a very common mental disorder. Research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term management of the disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Attention Bias Modification and Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2015to 30 Nov 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a history of major depression, currently in remission
Who cannot join
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sørlandet Hospital, Department of Psychiatry
Arendal, Aust-Agder, 4801
University of Oslo, Department of Psychology
Oslo, 0317
About this study
Official title: Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
Depression (major depressive disorder; MDD) is a very common mental disorder. Research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term management of the disease. The current project aims to investigate whether group based Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse in a group highly vulnerable to depressive episodes. The group intervention will consist of eight sessions, and each group will consist of maximum 12 persons. The project also studies whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the effect. ABM will be administered over a fourteen days period prior to the ACT-intervention. Effect will be measured over a period of 12 months. The primary outcome is changes in depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with a history of major depression (n=200), currently in remission, will be recruited from Sørlandet Hospital (100 participants). Matched participants (100 participants) will be recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital will be randomized to ABM treatment or control condition. In the second phase all participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT and ABM represent interventions that are time and cost effective, and that could be made available to large number of individuals struggling with MDD.
- Conditions
- Major Depression
- Being tested
- Attention Bias Modification, Sham Attention Bias Modification, Acceptance and Commitment Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias ModificationBehavioural
Also called ABM+
Computer based Attention Bias Modification
Sham Attention Bias ModificationBehavioural
Also called ABM-
Computer based Sham Attention Bias Modification
Acceptance and Commitment TherapyBehavioural
Also called ACT
Acceptance and Commitment Therapy delivered in a group therapy setting
| Study group | Role | What they receive |
|---|---|---|
| ABM + | Experimental | Attention Bias Modification Receives: Behavioral: Attention Bias Modification |
| ABM - | Sham comparator | Sham Attention Bias Modification Receives: Behavioral: Sham Attention Bias Modification |
| ABM + and ACT | Experimental | Attention Bias Modification followed by Group Acceptance and Commitment Therapy Receives: Behavioral: Attention Bias Modification; Behavioral: Acceptance and Commitment Therapy |
| ABM - and ACT | Sham comparator | Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy Receives: Behavioral: Sham Attention Bias Modification; Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in residual symptoms of depression - self report
Change in residual symptoms of depression as measured by Beck Depression Inventory
Measured: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Change in residual symptoms of depression - clinician rating
Change in residual symptoms of depression as rated by Hamilton Rating Scale for Depression
Measured: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Secondary outcomes (10)
Recurrence of major depressive episodes
Measured by MINI structured interview
Measured: Will be measured 12 months after baseline
Changes in Cortisol response
Cortisol measured in salvia. Samples taken in the morning on three days in succession.
Measured: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in symptoms of anxiety - self report
Change in symptoms of anxiety as measured by Beck Anxiety Inventory
Measured: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in Quality of Life - self report
WHOQOL-BREF
Measured: Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Changes in Acceptance - self report
The 7-item Acceptance and Action Questionnaire - II (AAQ-II)
Measured: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values - self report
Bulls Eye
Measured: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values and committed action - self report
Engaged living scale
Measured: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Emotional, Psychological and Social Well-Being - self report
Mental Health continuum - short form
Measured: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Present-moment awareness and acceptance - self report
Philadelphia mindfulness scale
Measured: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Changes in Cognitive fusion - self report
Cognitive fusion questionnaire
Measured: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startApr 2015
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo, University of Oxford, Karolinska Institutet, Wichita State University, The Hospital of Vestfold
- Responsible party
- Sponsor
- Investigators
- Vegard Ø Haaland, PhD, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648165
- Sponsor's protocol ID
- HSØ-2015056
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ostergaard T, Lundgren T, Zettle R, Jonassen R, Harmer CJ, Stiles TC, Landro NI, Haaland VO. Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):203. doi: 10.1186/s13063-018-2515-9.
PubMed 29587807
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure
- ClinicalTrials.gov ID
- NCT02648165
- Acronym / sponsor ID
- HSØ-2015056
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Oslo, University of Oxford, Karolinska Institutet, Wichita State University, The Hospital of Vestfold
- Study start
- Apr 2015
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 6 Jan 2016 (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.
Depression (major depressive disorder; MDD) is a very common mental disorder. Research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term management of the disease. The current project aims to investigate whether group based Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse in a group highly vulnerable to depressive episodes. The group intervention will consist of eight sessions, and each group will consist of maximum 12 persons. The project also studies whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the effect. ABM will be administered over a fourteen days period prior to the ACT-intervention. Effect will be measured over a period of 12 months. The primary outcome is changes in depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with a history of major depression (n=200), currently in remission, will be recruited from Sørlandet Hospital (100 participants). Matched participants (100 participants) will be recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital will be randomized to ABM treatment or control condition. In the second phase all participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT and ABM represent interventions that are time and cost effective, and that could be made available to large number of individuals struggling with MDD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABM + | Experimental | Behavioral: Attention Bias ModificationAttention Bias Modification |
| ABM - | Sham comparator | Behavioral: Sham Attention Bias ModificationSham Attention Bias Modification |
| ABM + and ACT | Experimental | Behavioral: Attention Bias Modification, Behavioral: Acceptance and Commitment TherapyAttention Bias Modification followed by Group Acceptance and Commitment Therapy |
| ABM - and ACT | Sham comparator | Behavioral: Sham Attention Bias Modification, Behavioral: Acceptance and Commitment TherapySham Attention Bias Modification followed by Group Acceptance and Commitment Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a history of major depression, currently in remission
Key exclusion criteria (1 listed)
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
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 |
|---|---|---|
| Attention Bias ModificationAlso: ABM+Computer based Attention Bias Modification | Behavioural | ABM +, ABM + and ACT |
| Sham Attention Bias ModificationAlso: ABM-Computer based Sham Attention Bias Modification | Behavioural | ABM -, ABM - and ACT |
| Acceptance and Commitment TherapyAlso: ACTAcceptance and Commitment Therapy delivered in a group therapy setting | Behavioural | ABM + and ACT, ABM - and ACT |
Primary outcome
Change in residual symptoms of depression - self report
Time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Change in residual symptoms of depression as measured by Beck Depression Inventory
Change in residual symptoms of depression - clinician rating
Time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Change in residual symptoms of depression as rated by Hamilton Rating Scale for Depression
10 secondary outcomes
Recurrence of major depressive episodes
Time frame: Will be measured 12 months after baseline
Changes in Cortisol response
Time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in symptoms of anxiety - self report
Time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months
Changes in Quality of Life - self report
Time frame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months
Changes in Acceptance - self report
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values - self report
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Values and committed action - self report
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Emotional, Psychological and Social Well-Being - self report
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months
Changes in Present-moment awareness and acceptance - self report
Time frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
Changes in Cognitive fusion - self report
Time frame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)
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 8 Feb 2023.
- Derived from this study: PubMed 29587807Ostergaard T, Lundgren T, Zettle R, Jonassen R, Harmer CJ, Stiles TC, Landro NI, Haaland VO. Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):203. doi: 10.1186/s13063-018-2515-9.
- Individual participant dataSharing planned: No
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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.
Vegard Ø Haaland, PhD principal investigator
Sorlandet Hospital HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification and Acceptance and Commitment Therapy in people with Major Depression, run by Sorlandet Hospital HF at 2 sites in Norway.
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 1 inclusion and 1 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. Some participants in this study may receive a placebo. 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?
Change in residual symptoms of depression - self report (time frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months). The study lists 2 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 NCT02648165, which also lists 1 linked publication.
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 8 Feb 2023.