Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Behavioral: Attention Bias Modification
* Behavioral: Sham Attention Bias Modification
* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a history of major depression, currently in remission Exclusion Criteria: Current or past neurological illness, bipolar disorder, psychosis or drug addiction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABM +<br>Attention Bias Modification | Behavioral: Attention Bias Modification<br>* Computer based Attention Bias Modification<br>* Other names: ABM+;|
| Sham Comparator: ABM -<br>Sham Attention Bias Modification | Behavioral: Sham Attention Bias Modification<br>* Computer based Sham Attention Bias Modification<br>* Other names: ABM-;|
| Experimental: ABM + and ACT<br>Attention Bias Modification followed by Group Acceptance and Commitment Therapy | Behavioral: Attention Bias Modification<br>* Computer based Attention Bias Modification<br>* Other names: ABM+;Behavioral: Acceptance and Commitment Therapy<br>* Acceptance and Commitment Therapy delivered in a group therapy setting<br>* Other names: ACT;|
| Sham Comparator: ABM - and ACT<br>Sham Attention Bias Modification followed by Group Acceptance and Commitment Therapy | Behavioral: Sham Attention Bias Modification<br>* Computer based Sham Attention Bias Modification<br>* Other names: ABM-;Behavioral: Acceptance and Commitment Therapy<br>* Acceptance and Commitment Therapy delivered in a group therapy setting<br>* Other names: ACT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in residual symptoms of depression - self report | Change in residual symptoms of depression as measured by Beck Depression Inventory | 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 | Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of major depressive episodes | Measured by MINI structured interview | 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. | 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 | 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 | 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) | Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months | 
| Changes in Values - self report | Bulls Eye | 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 | 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 | 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 | 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 | 1 month, 2 months, 6 months, 12 months (only in ACT-arms) |