Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for Suicidal Older Adults in a Swedish Geropsychiatric Setting

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• Suicidal Ideation 530
• Suicide 714
• Suicide, Attempted 267

Suicidal Ideation

530 studies on the registry are indexed under Suicidal Ideation; 198 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 440 interventional studies indexed under Suicidal Ideation.

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 272 studies on the registry; 107 are open to participants now.

Study arms

• Experimental
  CRISP 70+

  Behavioral: CRISP 70+

Interventions

• BehavioralCRISP 70+

  CRISP 70+ includes 12 weekly sessions. The therapist and the patient identify and simplify cognitive reappraisal techniques, rate their effectiveness at reducing negative emotions in the therapist's office, and create a plan to repeatedly use and rate those techniques outside of the office, in between sessions. The intervention targets repetition and practice of individualized cognitive reappraisal strategies and includes the following cognitive reappraisal stages: identification of the "perfect storm"; identification of situations/triggers, negative emotions and thoughts; examination of the utility of negative emotions; reappraisal of an emotional trigger; distancing (shifting away) from the emotional experience; and reappraisal of the emotional response to the trigger. The intervention provides tailored collaborative care. Participants use a workbook with a personalized cognitive reappraisal plan and safety plan.

Primary outcomes

1. Severity of suicidal ideation

   Columbia-Suicide Severity Rating Scale (C-SSRS) Scores range from 0-5, where higher scores indicate more severe ideation.

   Time frame: Assessed at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-ups.

Secondary outcomes

1. Depressive symptoms

   Montgomery-Åsberg Depression Rating Scale (MADRS) Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.

   Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-up

2. Anxiety

   Generalized Anxiety Disorder 7-item scale (GAD-7). Each item yields a score of 0 to 3; the overall score thus ranges from 0 to 21. Higher GAD-7 score indicates more severely elevated anxiety.

   Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-up

3. Coping

   Brief - Coping Orientation to Problems Experienced Inventory (Brief-Cope) 28 item scale 1= I haven't been doing this at all 2= A little bit 3 = A medium amount 4= I've been doing this a lot. Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.

   Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-up

4. Emotion Regulation

   Emotion Regulation Questionnaire for emotional regulation (ERQ)(Gross \& John, 2003).

   Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-up

5. Sleep

   Insomnia Severity Index (ISI) (Bastien et al., 2001)

   Time frame: Secondary effect measures will be collected at baseline, immediately after the intervention (approx 12 weeks) and at the 6-month follow-up

Other outcomes

1. Therapeutic Alliance

   Working Alliance Inventory-Short Revised (WAI-SR) measures therapeutic alliance on 12 items on a 7-point Likert scale from 1 = "never" to 7 = "always

   Time frame: After the third session approx 3 weeks after of study inclusion

2. Adverse events

   Negative Effects Questionnaire (NEQ). It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances, as well as one open-ended question.

   Time frame: After the last CRISP session approx 12 weeks after study inclusion

3. Feasibility measure Acceptability

   Acceptability will be addressed in the qualitative interviews with patients post intervention.

   Time frame: After the last CRISP session approx 12 weeks after study inclusion

4. Feasibility measure - Appropriatness

   Appropriateness is measured in qualitative interviews and our measures appropriateness by Cronbach alpha and mean inter-item correlation in our questionnaires.

   Time frame: After the last CRISP session approx 12 weeks after study inclusion

5. Feasibility measure - Deliverability

   Recruitment data

   Time frame: Baseline

6. Feasibility measure - Fidelity

   To ensure good administration of the CRISP, the use therapist rated checklist

   Time frame: Post-intervention

Individual participant data

Plan to share: No