Clinical trial NCT06023732: Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression
Official title: Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression, A Single-case Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-09-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms.
Primary purpose: TREATMENT

Brief summary: The study is a single-case intervention study, evaluating effects of the treatment Behavioral activation and emotion-focused interventions for depression.

Research question and hypothesis

1. What is the effect of behavioural activation and emotion-focused interventions on patients' ratings of depressive symptoms, behavioural activation and emotion regulation difficulties?
2. What is the effect of behavioural activation and emotion-focused interventions on patients' overall psychiatric state, with regards to ratings of anxiety, quality of life, level of functioning?
3. How does patient ratings of behavioural activation and emotion regulation difficulties and skills change during the course of treatment, in relation to treatment/session content?

Detailed description: Procedure The study will be carried out by the authors or experienced clinicians (master level students at the Psychotherapy program at the Karolinska Institute), recruiting and treating patients with recurring depression at a primary care unit in the Stockholm region. 7 patients will be treated during 15 weeks. The treatment will be carried out in a blended format with an internet-based treatment supported with therapist face-to-face sessions. The initial behavioural activation phase lasts up to 6 weeks followed by additional emotion focused interventions. The treatment is initiated by a therapist session, thereafter therapist sessions are planned approximately every 3rd week.

To be included in the study participants must meet diagnostic criteria for depression as their primary problem according to DSM-5 (Diagnostic and Statistical Manual), have basic reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with concurrent co-morbid psychiatric problems are eligible for inclusion unless another psychiatric diagnosis is assessed as primary to depression. Patients will be recruited from the regular flow of patients who seek treatment for psychological problems in the selected clinic. If interested they will be contacted by the study therapists and screened and assessed for eligibility after signing an informed consent.

Participants meeting inclusion criteria and not exclusion criteria will be offered participation in the study, and randomized to one of the 7 baseline lengths.

Methodology/approach/data analysis The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms. The B-phase will last 15 weeks and include the full internet-based treatment supported with 5-10 face-to-face therapist sessions .

Single-case experimental design (SCED) is particularly useful when evaluating a novel treatment in a clinical context as it produces reliable results even with a small sample size. Also, it is particularly helpful for studying the details of how the intervention works for each individual patient, through detailed and repeated measures of several dependent variables and processes. It is recommended that the effect of the intervention is assessed in at least 3 individuals (1), however, we will recruit at least 7 participants to allow for higher statistical power and as a safety measure for drop out and missing data.

Primary treatment effects in terms of depression, behavioural activation and emotion regulation will be assessed daily from day of inclusion to end of follow-up, with brief versions of self-rated measures with good reliability and validity. Brief versions of the following scales will be used for the daily assessment; depressive symptoms PHQ-2 (2), difficulties in emotion regulation, and daily behavioural activation BADS (3). Longitudinal data will be analyzed with non-parametric statistical tests (1). Visual inspection will be used to analyse variability, trends and patterns of change in the daily assessments over the phases of treatment.

Kendal's Tau is a non-overlap statistical test that has been developed for analysing SCED time series data with adequate statistical power. It will be used to analyse statistical differences in the dependent variables between phases. Kendal's Tau will be complemented with Tau-U tests if there are statistical trends in the data-series. Statistical power is very difficult to calculate for this test but given the expected medium effect sizes of the interventions and the replication across five participants, the statistical power is assessed as adequate. Pre, post and follow-up data will be assessed at start of phase A, start of phase B, after phase B and at follow up 3 months post treatment. The measures used will be PHQ-9 (4) for depression, GAD-7 (5) for anxiety symptoms, WSAS (6) for disability and ISI (7) for symptoms of insomnia. To measure if the treatment affects emotion regulation, self-ratings of DERS 16 (8) will be used. Post treatment the CSQ-8 (9) will be used to assess treatment satisfaction and NEQ (10) to asses negative effects.

Eligibility criteria: Inclusion Criteria:

* meet diagnostic criteria for depression as their primary problem according to DSM-5
* have basic reading and writing skills in Swedish
* not express acute suicidal ideation

Exclusion Criteria:

* concurrent comorbid psychiatric problems assessed as primary to depression.

Primary outcomes:
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
measure: 2 item Behavioral Activation for Depression Scale (BADS)
timeFrame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
measure: Emotion Regulation
timeFrame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from pre intervention to follow up 6 months post intervention start
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to post intervention follow up 6 months post intervention start
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
timeFrame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
timeFrame: Change from pre intervention to follow up 6 months post intervention start
measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to follow up 6 months post intervention start
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to follow up 6 months post intervention start
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to post intervention (15 weeks post intervention start)
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to post post Behavioral activation phase (5 weeks post intervention start)
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to follow up 6 months post intervention start
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to follow up 12 months post intervention start
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Immediately post intervention
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Liljeholmens primary care centre
Study officials:
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