Social Phobia
Conditions
Keywords
randomized controlled trial, stepped-care program, cognitive therapy of social phobia according to D.M. Clark
Brief summary
Primary objective: The purpose of this study is to examine efficacy and efficiency of a Stepped Care Program (SCP) for patients with Social Phobia in comparison to the standard cognitive therapy for Social Phobia according to D.M. Clark. Secondary objective: Further, it is intended to identify mechanisms of change which mediate treatment outcome and to identify differential predictors for therapy success for the two treatment conditions.
Detailed description
With prevalence rates (lifetime) up to 13% in western countries, Social Phobia is one of the most frequent mental disorders. Main objective of this clinical trial is the evaluation of the efficacy and efficiency of a stepped care program for patients with Social Phobia (SCP) as compared to a standard therapy (ST) for patients with social phobia. Both interventions are based on the cognitive therapy according to D.M. Clark. The SCP starts with a 8-sessions self-help-module with minimal therapist contact via email. Patients who do not reach remission after this first step, enter step 2 which consists of 8 therapy sessions guided by a therapist. If patients are not remitted after that, they receive another 8 sessions of therapist-guided cognitive treatment in step 3. So the SCP contains 8, 16 or 24 sessions of therapy - depending on remission status of the patient. In contrast to that, the ST comprises 16 sessions of therapist-guided intervention. The diagnostic status of the patients is assessed by blinded clinician raters before treatment, after every eighth therapy session, and at 5 follow-up timepoints in order to examine the stability of treatment effects (3, 6, 9, 12 and 30 months after the end of therapy). Besides efficacy and efficiency of the SCP vs. ST, mechanisms of change and differential predictors for therapy outcome will be investigated. Hypotheses: We expect that 1. the SCP is significantly more effective than the ST. 2. the SCP is significantly more efficient than the ST. 3. the results referring to the efficacy will be stable up to 30 months after the end of treatment(Follow Up Phase). 4. the SCP will cause less primary and secondary costs than the ST. 5. successful therapy leads to an improvement in the following areas: * reduction of biased information processing, * reduction of negative thoughts, subjective anxiety, safety behaviors, self-focused attention and autonomic arousal in anxiety-provoking situations, * amelioration of verbal and non-verbal social competence in anxiety- provoking situations. As mediators of change, the factors maintaining social anxiety according to the model of Social Phobia by Clark and Wells (1995) will be investigated.
Interventions
BEHAVIORALcognitive therapy
changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
BEHAVIORALstepped care program based on cognitive therapy
starting with a digital-video-disk-based (DVD-based) self-help module (8 Sessions) followed by face-to-face-therapy including 8 or 16 sessions depending on remission status; including: changing safety behaviors, self-focused attention, and automatic negative thoughts in anxiety-provoking situations via cognitive techniques, for example role plays and behavioral experiments
Sponsors
German Research Foundation
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Social Phobia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) * Duration of the disorder at least 1 year * Severity of symptomatology according to at least one of two self-report measures for social anxiety above Cut-Off: Social Interaction Anxiety Scale (SIAS: value of 26 or more) and / or Social Phobia Scale (SPS: value of 17 or more) * Age: 18-60 * Written Informed Consent
Exclusion criteria
* Social Phobia is not the main diagnosis * Mental Retardation * Lifetime Diagnoses: Schizophreniform Disorder, Bipolar Affective Disorder * Acute Diagnoses: severe Major Depression Episode, severe Anorexia Nervosa, Substance-, Drug - or Alcohol-Dependence, life-threatening suicidal crisis * Psychotropic medication (except stable treatment with antidepressant since 3 months before study start: medication and dosage has to be stable during the entire study duration)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Social Interaction Anxiety Scale (SIAS) | baseline to post-treatment (on average 24 weeks) | This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome. |
| Change From Baseline in Social Phobia Scale (SPS) | baseline to post-treatment (on average 24 weeks) | The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome. |
| Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | baseline to post-treatment (on average 24 weeks) | The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brief Symptom Inventory (BSI) | baseline to post-treatment (on average 24 weeks) | The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome. |
| Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | baseline to post-treatment (on average 24 weeks) | The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stepped Care Program stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission | 46 |
| Standardtherapy standard therapy (therapist-guided intervention only) | 43 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | family affairs | 2 | 0 |
| Overall Study | Lack of Efficacy | 5 | 4 |
| Overall Study | Withdrawal by Subject | 17 | 1 |
Baseline characteristics
| Characteristic | Standardtherapy | Stepped Care Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 46 Participants | 89 Participants |
| Age Continuous | 38.47 years STANDARD_DEVIATION 10.26 | 37.26 years STANDARD_DEVIATION 10.47 | 37.84 years STANDARD_DEVIATION 10.33 |
| Region of Enrollment Germany | 43 participants | 46 participants | 89 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)
The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.
Time frame: baseline to post-treatment (on average 24 weeks)
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Program | Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | baseline | 57.46 units on a scale | Standard Deviation 23.61 |
| Stepped Care Program | Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | post-treatment | 41.22 units on a scale | Standard Deviation 23.49 |
| Standardtherapy | Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | baseline | 60.58 units on a scale | Standard Deviation 19.37 |
| Standardtherapy | Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) | post-treatment | 31.84 units on a scale | Standard Deviation 21.57 |
p-value: <0.05ANOVA
Primary
Change From Baseline in Social Interaction Anxiety Scale (SIAS)
This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.
Time frame: baseline to post-treatment (on average 24 weeks)
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Program | Change From Baseline in Social Interaction Anxiety Scale (SIAS) | baseline | 43.13 units on a scale | Standard Deviation 14.26 |
| Stepped Care Program | Change From Baseline in Social Interaction Anxiety Scale (SIAS) | post-treatment | 34.85 units on a scale | Standard Deviation 14.86 |
| Standardtherapy | Change From Baseline in Social Interaction Anxiety Scale (SIAS) | baseline | 48.94 units on a scale | Standard Deviation 11 |
| Standardtherapy | Change From Baseline in Social Interaction Anxiety Scale (SIAS) | post-treatment | 33.35 units on a scale | Standard Deviation 16.9 |
p-value: <0.05ANOVA
Primary
Change From Baseline in Social Phobia Scale (SPS)
The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.
Time frame: baseline to post-treatment (on average 24 weeks)
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Program | Change From Baseline in Social Phobia Scale (SPS) | baseline | 35.85 units on a scale | Standard Deviation 14.97 |
| Stepped Care Program | Change From Baseline in Social Phobia Scale (SPS) | post-treatment | 24.89 units on a scale | Standard Deviation 17.41 |
| Standardtherapy | Change From Baseline in Social Phobia Scale (SPS) | baseline | 33.95 units on a scale | Standard Deviation 13.12 |
| Standardtherapy | Change From Baseline in Social Phobia Scale (SPS) | post-treatment | 17.58 units on a scale | Standard Deviation 13.36 |
p-value: <0.05ANOVA
Secondary
Change From Baseline in Brief Symptom Inventory (BSI)
The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.
Time frame: baseline to post-treatment (on average 24 weeks)
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Program | Change From Baseline in Brief Symptom Inventory (BSI) | baseline | 1.00 units on a scale | Standard Deviation 0.59 |
| Stepped Care Program | Change From Baseline in Brief Symptom Inventory (BSI) | post-treatment | 0.71 units on a scale | Standard Deviation 0.51 |
| Standardtherapy | Change From Baseline in Brief Symptom Inventory (BSI) | baseline | 0.90 units on a scale | Standard Deviation 0.56 |
| Standardtherapy | Change From Baseline in Brief Symptom Inventory (BSI) | post-treatment | 0.51 units on a scale | Standard Deviation 0.51 |
p-value: <0.05ANOVA
Secondary
Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.
Time frame: baseline to post-treatment (on average 24 weeks)
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Program | Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | baseline | 21.48 units on a scale | Standard Deviation 9.97 |
| Stepped Care Program | Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | post-treatment | 16.20 units on a scale | Standard Deviation 10.26 |
| Standardtherapy | Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | baseline | 21.47 units on a scale | Standard Deviation 11.04 |
| Standardtherapy | Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | post-treatment | 14.28 units on a scale | Standard Deviation 9.93 |
p-value: <0.05ANOVA