Staying Well After Depression: a randomised trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Aged 18 years or over, and not older than 70 years due to the fact that depression in old age has often been found to be related to different factors than depression in earlier stages of life. Male or female.
2. Meeting enhanced Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a history of recurrent major depression, i.e. history of at least three episodes of depression, two of which must have occurred within the last five years, of which one must have occurred within the last two years. Although previous suicidality is recorded in detail (which allows stratification to be carried out on this basis) participants are not included/excluded from the study on the basis of their prior experience of suicidality.
3. Meeting the National Institute of Mental Health (NIMH) guidelines for recovery or remission at the time of baseline assessment. For the purposes of the trial participants are NOT deemed to be in recovery or remission (and hence are ineligible) if they report a week (or more) during the previous 8 weeks during which they experienced EITHER a core symptom of depression (depressed mood, anhedonia) or suicidal feelings AND at least one other symptom of depression, which together are not accounted for by bereavement or substances/general medical conditions, and which are accompanied by significant impairment in functioning.
4. Giving informed consent
5. Consent received from the participant's General Practitioner

Exclusion Criteria

Participants are excluded from the study if one or more of the following apply:
1. They have a history of schizophrenia, schizoaffective disorder, bipolar I disorder, current and severe substance abuse, organic mental disorder, pervasive developmental delay, a primary diagnosis of obsessive-compulsive disorder or eating disorder, or are currently regularly self-harming
2. They are showing a positive and continuing response to CBT
3. They have current psychotherapy or counseling more frequently than once per month
4. They are unable to complete the baseline research assessment (e.g. due to difficulties with English, visual impairment, or cognitive difficulties)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to relapse or recurrence meeting DSM-IV criteria for major depression, assessed using the Structured Clinical Interview for DSM-IV (SCID). Occurrence of relapse/recurrence is assessed at all follow-up assessments, and ?return to treatment? will be treated as a relapse/recurrence if, in the judgment of a blind assessor, the participant has experienced exacerbation of symptoms that would have met the criteria for major depression in the absence of immediate treatment. In addition to diagnostic status, we assess severity of depression and hopelessness using a number of interview and self-report measures including the Hamilton Rating Scale for Depression, the Beck Depression Inventory and the Beck Hopelessness Scale, at all time points. These quantitative measures complement the dichotomised outcome of diagnosis.<br><br>Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.

Secondary Outcome Measures

Name	Time	Method
1. Cognitive measures relevant to risk of relapse/recurrence (mindfulness, self-compassion, rumination, self discrepancy, autobiographical memory, and executive capacity) are assessed before and immediately after the treatment as well as at the end of the follow-up, and will be used in an explanatory analysis to examine factors that mediate and moderate efficacy<br>2. Severity of suicidal ideation/behaviour both within and between episodes of depression during the follow-up period<br><br>Outcomes measured pre-treatment, post-treatment and at 3, 6, 9, and 12 months follow-up.